› Forums › General Melanoma Community › Scan results and possible options…
- This topic has 36 replies, 10 voices, and was last updated 12 years, 2 months ago by Ali.
- Post
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- February 20, 2012 at 2:29 am
Well the most recent CT scan show the tumors in my lungs are still progressing since my last scan on Jan 9th. Some at faster, more alarming rates, and some not so much. Not the news I was hoping for, but, it is what it is, just another little speed bump. I’m in a tricky spot right now. On one hand, as unlikely as it seems, I guess the Yervoy could essentially still kick in any minute, it's been 2 months since my final dose. On the other hand, things are getting worse, and waiting for something that’s unlikely and may not happen may not be in my best interest.
Well the most recent CT scan show the tumors in my lungs are still progressing since my last scan on Jan 9th. Some at faster, more alarming rates, and some not so much. Not the news I was hoping for, but, it is what it is, just another little speed bump. I’m in a tricky spot right now. On one hand, as unlikely as it seems, I guess the Yervoy could essentially still kick in any minute, it's been 2 months since my final dose. On the other hand, things are getting worse, and waiting for something that’s unlikely and may not happen may not be in my best interest. Some would say wait it out, some would say move on, and they are.
As suggested by both of my oncologists, before finalizing a decision to wait it out or go with zelboraf, I spent the last 3 days getting every bit of attainable information (disks, written reports, lab notes) of all recent treatments and medical history together and contacted my most recent doctor and team at the National Institute of Health with a brief update of what has been going on, in hopes that maybe they’ll have a trial or an idea we could both benefit from. Maybe they could hit me with the ACT again, as intense as it was, I would love another shot. Or maybe they've got something new to try, something I'd seem like a good candidate for. She agreed to look them over, discuss any options with the team and get back to me. Personally the thought of going back there, just makes my heart warm. At this exact time last year, I was on the mend because of their help, I remember the feeling, and the thought of possibly feeling like that again is… well it makes me smile, a true smile of unabashed happiness and hope. I know the chances of them accepting me for something aren't that great, but with all my history there, and a bit of much needed luck, maybe they will. We'll see. I fed-exed everything yesterday at the fastest rate possible, and hope to hear from them early this week. As always, this waiting in uncertainty is the hardest part, but I’ll be ok.
On a lighter note, I still feel fine, no pain, trouble breathing, nothing too abnormal from what I can tell. Of course there's some anxiety and nervousness, but during times like these I'm sure it's a pretty normal human reaction and will pass as soon as a plan is in course.
Hopefully I'll have a plan and something beneficial to look forward to in the coming days. Until then, thank you all for the ongoing support and help though these stressful times. It means so much.
I'll talk to you soon.
-Kevin
- Replies
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- February 20, 2012 at 3:05 am
Kevin—God bless you. I am amazed at the stories I read here. I took my last relaxed breath the minute before my husband's derm said Melanoma.
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- February 20, 2012 at 3:05 am
Kevin—God bless you. I am amazed at the stories I read here. I took my last relaxed breath the minute before my husband's derm said Melanoma.
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- February 20, 2012 at 3:05 am
Kevin—God bless you. I am amazed at the stories I read here. I took my last relaxed breath the minute before my husband's derm said Melanoma.
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- February 20, 2012 at 5:51 am
Kevin, thanks for the latest update. There is always the possibility that you might respond to Yervoy. I don't know if you would be eligible for an anti PD-1 clinical trial, but that could be considered as another option.
Take care
Frank from Australia
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- February 20, 2012 at 7:13 am
Kevin,
Consider this trial perhaps…
This is the sister trial of mine…the 4,5,and 6 arm allows for previous use of Anti PD 1
Phase I Pilot Study of Peptide Vaccine Comprising gp100:209-217(210M), MART-1:26-35(27L), gp100:280-288(288V), and NY-ESO-1 Emulsified in Montanide ISA 51 VG and Anti-PD-1 Human Monoclonal Antibody MDX-1106 in Patients With Unresectable Stage III or IV Melanoma
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry InformationAlternate Title
Vaccine Therapy and Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
Basic Trial Information
Phase Type Status Age Sponsor Protocol IDs Phase I Biomarker/Laboratory analysis, Treatment Active 16 and over NCI MCC-15400
MCC-15400, 7997, NCT01176461Objectives
Primary
- To assess the safety and tolerability of multiple class I peptide vaccine comprising gp100:209-217(210M), MART-1:26-35(27L), gp100:280-288(288V), and NY-ESO-1 emulsified in Montanide ISA 51 VG and anti-PD-1 human monoclonal antibody MDX-1106 (BMS-936558) in HLA-A*0201-positive patients with unresectable stage III or IV malignant melanoma (patients in cohort 6 will not be HLA restricted).
Secondary
- To evaluate the immune response at week 12 in patients treated with these regimens compared to the immune response to peptide vaccine alone that was determined in previous studies.
- To assess the host immune response (immunogenicity) to BMS-936558.
- To assess, preliminarily, the efficacy of these regimens in these patients.
Entry Criteria
Disease Characteristics:
- Histologically confirmed melanoma
- Unresectable stage III or IV disease
- HLA-A*0201 positive by DNA allele-specific PCR assay (not a requirement for cohort 6)
- Positive staining of tumor tissue for ≥ 1 of the following: antibody HMB-45 for gp100, NY-ESO-1, and/or MART-1
- At least 1 measurable lesion
- Must have failed ≥ 1 chemotherapy regimen for metastatic disease
- Must have failed prior ipilimumab (cohorts 4, 5, and 6)
- Prior treated brain and meningeal metastases allowed provided the following criteria are met:
- No evidence of progression by MRI within the past 8 weeks
- Off immunosuppressive doses of systemic steroids (> 10 mg/day prednisone or equivalent) for ≥ 2 weeks
Prior/Concurrent Therapy:
- See Disease Characteristics
- May have received ≤ 2 prior chemotherapy regimens
- At least 4 weeks since prior chemotherapy or immunotherapy (tumor vaccine, cytokine, or growth factor given to control the cancer) and recovered
- At least 2 weeks since prior immunosuppressive doses of systemic medications, such as steroids or absorbed topical steroids (> 10 mg/day prednisone or equivalent)
- At least 4 weeks since prior systemic radiotherapy
- At least 2 weeks since prior focal radiotherapy
- More than 8 weeks since prior radiopharmaceuticals (strontium, samarium)
- At least 6 weeks since prior nitrosourea
- At least 2 weeks since prior surgery that required general anesthesia
- At least 72 hours since prior surgery requiring local and/or epidural anesthesia
- No prior anti-PD-1, anti-PD-L1, anti-PDL-2, or anti-CTLA-4 antibody (or any other antibody targeting T-cell costimulation pathways)
- No concurrent participation in another clinical study involving treatment with medications, radiotherapy, or surgery or prior participation in this study
- No concurrent use of any of the following:
- Other anticancer agents
- Immunosuppressive agents
- Immunosuppressive doses of systemic or topical steroids whose absorption is expected to result in systemically immunosuppressive steroid levels
- Non-oncologic vaccines (during and ≥ 4 weeks after study treatment)
- Patients in the fourth cohort must meet the following criteria:
- Ipilimumab at 3 mg/kg must have been completed not less than 4 weeks prior to initiation of anti-PD-1 human monoclonal antibody MDX-1106 (MDX-1106)
- Ipilimumab at 10 mg/kg must have been completed not less than 6 weeks prior to initiation of MDX-1106
- All drug-related toxicities must have resolved to grade 1 or less or non-DLT grade 2
- Patients must be off steroids for at least 3 weeks
- No patients who required infliximab or other immune suppressants including mycophenolic acid
- Patients in the fifth and sixth cohort must meet the following criteria:
- Ipilimumab at 3 mg/kg or 10 mg/kg must have been completed not less than 8 weeks prior to initiation of MDX-1106
- All drug-related toxicities must have resolved to grade 1 or less or non-DLT grade 2
- Patients must be off steroids for at least 3 weeks
- No patients who required infliximab or other immune suppressants including mycophenolic acid
Patient Characteristics:
- ECOG performance status 0-1
- Life expectancy ≥ 3 months
- WBC ≥ 2,000/μL
- ANC ≥ 1,500/μL
- Platelet count ≥ 100,000/μL
- Hemoglobin ≥ 9.0 g/dL
- Serum creatinine ≤ 2 mg/dL
- AST and/or ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN for hepatic metastasis)
- Bilirubin ≤ 2 times ULN (< 3 times ULN for patients with Gilbert syndrome)
- Fertile patients must agree to use effective contraception for ≥ 28 days before, during, and for ≥ 70 days (180 days for males) after completion of treatment period
- Negative pregnancy test
- Not pregnant or nursing
- Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol
- No history of severe hypersensitivity reactions to other monoclonal antibodies
- No systemic hypersensitivity to Montanide ISA 51 VG or any vaccine component
- No active malignancy within the past 2 years except for curatively treated local cancer, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast
- No prior or active autoimmune disease, or history of syndrome requiring systemic steroids or immunosuppressive medications
- Patients with vitiligo or resolved childhood asthma and/or atopy allowed
- No known HIV positivity or AIDS
- Not positive for hepatitis B virus surface antigen or hepatitis C virus RNA indicating active or chronic infection
- No underlying medical condition (e.g., a condition associated with diarrhea) that, in the investigator's opinion, would make the administration of any of the study drugs hazardous to the patient, or obscure the interpretation of toxicity determination or adverse events
- No concurrent medical condition requiring the use of immunosuppressive doses of systemic or absorbable topical corticosteroids
Expected Enrollment
85
Outcomes
Primary Outcome(s)
Best overall response (complete or partial response, stable disease, or progressive disease)
Adverse eventsSecondary Outcome(s)
Time to response
Duration of responseOutline
This is a dose-escalation study of anti-PD-1 human monoclonal antibody MDX-1106.
Patients receive peptide vaccines* comprising gp 100 (210M), MART-1 (27L), gp100 (288V), and NY-ESO-1(165V) emulsified by Montanide ISA 51 VG subcutaneously and anti-PD-1 human monoclonal antibody MDX-1106 IV over 60 minutes once a week on weeks 1, 3, 5, 7, 9, and 11. Treatment repeats every 12 weeks for 2 courses. Patients with responsive or stable disease continue to receive anti-PD-1 human monoclonal antibody MDX-1106 IV over 60 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
[Note: *Patients in cohorts 1-5 will receive the peptide vaccine, but not those in cohort 6.]
Blood samples are collected for pharmacokinetic and immunologic analysis.
After completion of study therapy, patients are followed up periodically for 2 years.
Trial Lead Organizations
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Jeffrey Weber, MD, PhD, Principal investigator Ph: 813-747-2691; 888-663-3488 U.S.A. Florida Tampa H. Lee Moffitt Cancer Center and Research Institute at University of South Florida Clinical Trials Office – H. Lee Moffitt Cancer Center and Reseach Institute Ph: 800-456-7121 Email: [email protected] NCT01176461 Date Submitted to PDQ 2010-08-02 Information Last Verified 2012-02-14 NCI Grant/Contract Number CA-129594 Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
-
- February 20, 2012 at 7:13 am
Kevin,
Consider this trial perhaps…
This is the sister trial of mine…the 4,5,and 6 arm allows for previous use of Anti PD 1
Phase I Pilot Study of Peptide Vaccine Comprising gp100:209-217(210M), MART-1:26-35(27L), gp100:280-288(288V), and NY-ESO-1 Emulsified in Montanide ISA 51 VG and Anti-PD-1 Human Monoclonal Antibody MDX-1106 in Patients With Unresectable Stage III or IV Melanoma
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry InformationAlternate Title
Vaccine Therapy and Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
Basic Trial Information
Phase Type Status Age Sponsor Protocol IDs Phase I Biomarker/Laboratory analysis, Treatment Active 16 and over NCI MCC-15400
MCC-15400, 7997, NCT01176461Objectives
Primary
- To assess the safety and tolerability of multiple class I peptide vaccine comprising gp100:209-217(210M), MART-1:26-35(27L), gp100:280-288(288V), and NY-ESO-1 emulsified in Montanide ISA 51 VG and anti-PD-1 human monoclonal antibody MDX-1106 (BMS-936558) in HLA-A*0201-positive patients with unresectable stage III or IV malignant melanoma (patients in cohort 6 will not be HLA restricted).
Secondary
- To evaluate the immune response at week 12 in patients treated with these regimens compared to the immune response to peptide vaccine alone that was determined in previous studies.
- To assess the host immune response (immunogenicity) to BMS-936558.
- To assess, preliminarily, the efficacy of these regimens in these patients.
Entry Criteria
Disease Characteristics:
- Histologically confirmed melanoma
- Unresectable stage III or IV disease
- HLA-A*0201 positive by DNA allele-specific PCR assay (not a requirement for cohort 6)
- Positive staining of tumor tissue for ≥ 1 of the following: antibody HMB-45 for gp100, NY-ESO-1, and/or MART-1
- At least 1 measurable lesion
- Must have failed ≥ 1 chemotherapy regimen for metastatic disease
- Must have failed prior ipilimumab (cohorts 4, 5, and 6)
- Prior treated brain and meningeal metastases allowed provided the following criteria are met:
- No evidence of progression by MRI within the past 8 weeks
- Off immunosuppressive doses of systemic steroids (> 10 mg/day prednisone or equivalent) for ≥ 2 weeks
Prior/Concurrent Therapy:
- See Disease Characteristics
- May have received ≤ 2 prior chemotherapy regimens
- At least 4 weeks since prior chemotherapy or immunotherapy (tumor vaccine, cytokine, or growth factor given to control the cancer) and recovered
- At least 2 weeks since prior immunosuppressive doses of systemic medications, such as steroids or absorbed topical steroids (> 10 mg/day prednisone or equivalent)
- At least 4 weeks since prior systemic radiotherapy
- At least 2 weeks since prior focal radiotherapy
- More than 8 weeks since prior radiopharmaceuticals (strontium, samarium)
- At least 6 weeks since prior nitrosourea
- At least 2 weeks since prior surgery that required general anesthesia
- At least 72 hours since prior surgery requiring local and/or epidural anesthesia
- No prior anti-PD-1, anti-PD-L1, anti-PDL-2, or anti-CTLA-4 antibody (or any other antibody targeting T-cell costimulation pathways)
- No concurrent participation in another clinical study involving treatment with medications, radiotherapy, or surgery or prior participation in this study
- No concurrent use of any of the following:
- Other anticancer agents
- Immunosuppressive agents
- Immunosuppressive doses of systemic or topical steroids whose absorption is expected to result in systemically immunosuppressive steroid levels
- Non-oncologic vaccines (during and ≥ 4 weeks after study treatment)
- Patients in the fourth cohort must meet the following criteria:
- Ipilimumab at 3 mg/kg must have been completed not less than 4 weeks prior to initiation of anti-PD-1 human monoclonal antibody MDX-1106 (MDX-1106)
- Ipilimumab at 10 mg/kg must have been completed not less than 6 weeks prior to initiation of MDX-1106
- All drug-related toxicities must have resolved to grade 1 or less or non-DLT grade 2
- Patients must be off steroids for at least 3 weeks
- No patients who required infliximab or other immune suppressants including mycophenolic acid
- Patients in the fifth and sixth cohort must meet the following criteria:
- Ipilimumab at 3 mg/kg or 10 mg/kg must have been completed not less than 8 weeks prior to initiation of MDX-1106
- All drug-related toxicities must have resolved to grade 1 or less or non-DLT grade 2
- Patients must be off steroids for at least 3 weeks
- No patients who required infliximab or other immune suppressants including mycophenolic acid
Patient Characteristics:
- ECOG performance status 0-1
- Life expectancy ≥ 3 months
- WBC ≥ 2,000/μL
- ANC ≥ 1,500/μL
- Platelet count ≥ 100,000/μL
- Hemoglobin ≥ 9.0 g/dL
- Serum creatinine ≤ 2 mg/dL
- AST and/or ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN for hepatic metastasis)
- Bilirubin ≤ 2 times ULN (< 3 times ULN for patients with Gilbert syndrome)
- Fertile patients must agree to use effective contraception for ≥ 28 days before, during, and for ≥ 70 days (180 days for males) after completion of treatment period
- Negative pregnancy test
- Not pregnant or nursing
- Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol
- No history of severe hypersensitivity reactions to other monoclonal antibodies
- No systemic hypersensitivity to Montanide ISA 51 VG or any vaccine component
- No active malignancy within the past 2 years except for curatively treated local cancer, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast
- No prior or active autoimmune disease, or history of syndrome requiring systemic steroids or immunosuppressive medications
- Patients with vitiligo or resolved childhood asthma and/or atopy allowed
- No known HIV positivity or AIDS
- Not positive for hepatitis B virus surface antigen or hepatitis C virus RNA indicating active or chronic infection
- No underlying medical condition (e.g., a condition associated with diarrhea) that, in the investigator's opinion, would make the administration of any of the study drugs hazardous to the patient, or obscure the interpretation of toxicity determination or adverse events
- No concurrent medical condition requiring the use of immunosuppressive doses of systemic or absorbable topical corticosteroids
Expected Enrollment
85
Outcomes
Primary Outcome(s)
Best overall response (complete or partial response, stable disease, or progressive disease)
Adverse eventsSecondary Outcome(s)
Time to response
Duration of responseOutline
This is a dose-escalation study of anti-PD-1 human monoclonal antibody MDX-1106.
Patients receive peptide vaccines* comprising gp 100 (210M), MART-1 (27L), gp100 (288V), and NY-ESO-1(165V) emulsified by Montanide ISA 51 VG subcutaneously and anti-PD-1 human monoclonal antibody MDX-1106 IV over 60 minutes once a week on weeks 1, 3, 5, 7, 9, and 11. Treatment repeats every 12 weeks for 2 courses. Patients with responsive or stable disease continue to receive anti-PD-1 human monoclonal antibody MDX-1106 IV over 60 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
[Note: *Patients in cohorts 1-5 will receive the peptide vaccine, but not those in cohort 6.]
Blood samples are collected for pharmacokinetic and immunologic analysis.
After completion of study therapy, patients are followed up periodically for 2 years.
Trial Lead Organizations
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Jeffrey Weber, MD, PhD, Principal investigator Ph: 813-747-2691; 888-663-3488 U.S.A. Florida Tampa H. Lee Moffitt Cancer Center and Research Institute at University of South Florida Clinical Trials Office – H. Lee Moffitt Cancer Center and Reseach Institute Ph: 800-456-7121 Email: [email protected] NCT01176461 Date Submitted to PDQ 2010-08-02 Information Last Verified 2012-02-14 NCI Grant/Contract Number CA-129594 Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
-
- February 20, 2012 at 7:13 am
Kevin,
Consider this trial perhaps…
This is the sister trial of mine…the 4,5,and 6 arm allows for previous use of Anti PD 1
Phase I Pilot Study of Peptide Vaccine Comprising gp100:209-217(210M), MART-1:26-35(27L), gp100:280-288(288V), and NY-ESO-1 Emulsified in Montanide ISA 51 VG and Anti-PD-1 Human Monoclonal Antibody MDX-1106 in Patients With Unresectable Stage III or IV Melanoma
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry InformationAlternate Title
Vaccine Therapy and Monoclonal Antibody Therapy in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
Basic Trial Information
Phase Type Status Age Sponsor Protocol IDs Phase I Biomarker/Laboratory analysis, Treatment Active 16 and over NCI MCC-15400
MCC-15400, 7997, NCT01176461Objectives
Primary
- To assess the safety and tolerability of multiple class I peptide vaccine comprising gp100:209-217(210M), MART-1:26-35(27L), gp100:280-288(288V), and NY-ESO-1 emulsified in Montanide ISA 51 VG and anti-PD-1 human monoclonal antibody MDX-1106 (BMS-936558) in HLA-A*0201-positive patients with unresectable stage III or IV malignant melanoma (patients in cohort 6 will not be HLA restricted).
Secondary
- To evaluate the immune response at week 12 in patients treated with these regimens compared to the immune response to peptide vaccine alone that was determined in previous studies.
- To assess the host immune response (immunogenicity) to BMS-936558.
- To assess, preliminarily, the efficacy of these regimens in these patients.
Entry Criteria
Disease Characteristics:
- Histologically confirmed melanoma
- Unresectable stage III or IV disease
- HLA-A*0201 positive by DNA allele-specific PCR assay (not a requirement for cohort 6)
- Positive staining of tumor tissue for ≥ 1 of the following: antibody HMB-45 for gp100, NY-ESO-1, and/or MART-1
- At least 1 measurable lesion
- Must have failed ≥ 1 chemotherapy regimen for metastatic disease
- Must have failed prior ipilimumab (cohorts 4, 5, and 6)
- Prior treated brain and meningeal metastases allowed provided the following criteria are met:
- No evidence of progression by MRI within the past 8 weeks
- Off immunosuppressive doses of systemic steroids (> 10 mg/day prednisone or equivalent) for ≥ 2 weeks
Prior/Concurrent Therapy:
- See Disease Characteristics
- May have received ≤ 2 prior chemotherapy regimens
- At least 4 weeks since prior chemotherapy or immunotherapy (tumor vaccine, cytokine, or growth factor given to control the cancer) and recovered
- At least 2 weeks since prior immunosuppressive doses of systemic medications, such as steroids or absorbed topical steroids (> 10 mg/day prednisone or equivalent)
- At least 4 weeks since prior systemic radiotherapy
- At least 2 weeks since prior focal radiotherapy
- More than 8 weeks since prior radiopharmaceuticals (strontium, samarium)
- At least 6 weeks since prior nitrosourea
- At least 2 weeks since prior surgery that required general anesthesia
- At least 72 hours since prior surgery requiring local and/or epidural anesthesia
- No prior anti-PD-1, anti-PD-L1, anti-PDL-2, or anti-CTLA-4 antibody (or any other antibody targeting T-cell costimulation pathways)
- No concurrent participation in another clinical study involving treatment with medications, radiotherapy, or surgery or prior participation in this study
- No concurrent use of any of the following:
- Other anticancer agents
- Immunosuppressive agents
- Immunosuppressive doses of systemic or topical steroids whose absorption is expected to result in systemically immunosuppressive steroid levels
- Non-oncologic vaccines (during and ≥ 4 weeks after study treatment)
- Patients in the fourth cohort must meet the following criteria:
- Ipilimumab at 3 mg/kg must have been completed not less than 4 weeks prior to initiation of anti-PD-1 human monoclonal antibody MDX-1106 (MDX-1106)
- Ipilimumab at 10 mg/kg must have been completed not less than 6 weeks prior to initiation of MDX-1106
- All drug-related toxicities must have resolved to grade 1 or less or non-DLT grade 2
- Patients must be off steroids for at least 3 weeks
- No patients who required infliximab or other immune suppressants including mycophenolic acid
- Patients in the fifth and sixth cohort must meet the following criteria:
- Ipilimumab at 3 mg/kg or 10 mg/kg must have been completed not less than 8 weeks prior to initiation of MDX-1106
- All drug-related toxicities must have resolved to grade 1 or less or non-DLT grade 2
- Patients must be off steroids for at least 3 weeks
- No patients who required infliximab or other immune suppressants including mycophenolic acid
Patient Characteristics:
- ECOG performance status 0-1
- Life expectancy ≥ 3 months
- WBC ≥ 2,000/μL
- ANC ≥ 1,500/μL
- Platelet count ≥ 100,000/μL
- Hemoglobin ≥ 9.0 g/dL
- Serum creatinine ≤ 2 mg/dL
- AST and/or ALT ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN for hepatic metastasis)
- Bilirubin ≤ 2 times ULN (< 3 times ULN for patients with Gilbert syndrome)
- Fertile patients must agree to use effective contraception for ≥ 28 days before, during, and for ≥ 70 days (180 days for males) after completion of treatment period
- Negative pregnancy test
- Not pregnant or nursing
- Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol
- No history of severe hypersensitivity reactions to other monoclonal antibodies
- No systemic hypersensitivity to Montanide ISA 51 VG or any vaccine component
- No active malignancy within the past 2 years except for curatively treated local cancer, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast
- No prior or active autoimmune disease, or history of syndrome requiring systemic steroids or immunosuppressive medications
- Patients with vitiligo or resolved childhood asthma and/or atopy allowed
- No known HIV positivity or AIDS
- Not positive for hepatitis B virus surface antigen or hepatitis C virus RNA indicating active or chronic infection
- No underlying medical condition (e.g., a condition associated with diarrhea) that, in the investigator's opinion, would make the administration of any of the study drugs hazardous to the patient, or obscure the interpretation of toxicity determination or adverse events
- No concurrent medical condition requiring the use of immunosuppressive doses of systemic or absorbable topical corticosteroids
Expected Enrollment
85
Outcomes
Primary Outcome(s)
Best overall response (complete or partial response, stable disease, or progressive disease)
Adverse eventsSecondary Outcome(s)
Time to response
Duration of responseOutline
This is a dose-escalation study of anti-PD-1 human monoclonal antibody MDX-1106.
Patients receive peptide vaccines* comprising gp 100 (210M), MART-1 (27L), gp100 (288V), and NY-ESO-1(165V) emulsified by Montanide ISA 51 VG subcutaneously and anti-PD-1 human monoclonal antibody MDX-1106 IV over 60 minutes once a week on weeks 1, 3, 5, 7, 9, and 11. Treatment repeats every 12 weeks for 2 courses. Patients with responsive or stable disease continue to receive anti-PD-1 human monoclonal antibody MDX-1106 IV over 60 minutes every 12 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
[Note: *Patients in cohorts 1-5 will receive the peptide vaccine, but not those in cohort 6.]
Blood samples are collected for pharmacokinetic and immunologic analysis.
After completion of study therapy, patients are followed up periodically for 2 years.
Trial Lead Organizations
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Jeffrey Weber, MD, PhD, Principal investigator Ph: 813-747-2691; 888-663-3488 U.S.A. Florida Tampa H. Lee Moffitt Cancer Center and Research Institute at University of South Florida Clinical Trials Office – H. Lee Moffitt Cancer Center and Reseach Institute Ph: 800-456-7121 Email: [email protected] NCT01176461 Date Submitted to PDQ 2010-08-02 Information Last Verified 2012-02-14 NCI Grant/Contract Number CA-129594 Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
-
- February 20, 2012 at 5:51 am
Kevin, thanks for the latest update. There is always the possibility that you might respond to Yervoy. I don't know if you would be eligible for an anti PD-1 clinical trial, but that could be considered as another option.
Take care
Frank from Australia
-
- February 20, 2012 at 5:51 am
Kevin, thanks for the latest update. There is always the possibility that you might respond to Yervoy. I don't know if you would be eligible for an anti PD-1 clinical trial, but that could be considered as another option.
Take care
Frank from Australia
-
- February 20, 2012 at 8:06 am
Hi Kevin
I feel your pain. I had a melanoma recurrence – 3 mets to the brain – in Oct. 2011. My doc, a very well respected melanoma doc at Mayo, put me on Zelboraf. So far so good, The only problems is that it is not a cure. Usually only lasts 6 months or so, so you need to have a plan b going in to it.
good luck, david
-
- February 20, 2012 at 8:06 am
Hi Kevin
I feel your pain. I had a melanoma recurrence – 3 mets to the brain – in Oct. 2011. My doc, a very well respected melanoma doc at Mayo, put me on Zelboraf. So far so good, The only problems is that it is not a cure. Usually only lasts 6 months or so, so you need to have a plan b going in to it.
good luck, david
-
- February 20, 2012 at 8:06 am
Hi Kevin
I feel your pain. I had a melanoma recurrence – 3 mets to the brain – in Oct. 2011. My doc, a very well respected melanoma doc at Mayo, put me on Zelboraf. So far so good, The only problems is that it is not a cure. Usually only lasts 6 months or so, so you need to have a plan b going in to it.
good luck, david
-
- February 20, 2012 at 9:09 am
Kevin,
I also tried the Yervoy route with no luck. Then IL2 – again no luck. I'm still hoping that maybe one or both of these treatments kick in late and do some good but I can't wait on that. Going to try another trial in a week and I understand there are others but I need get off this steroid first. The way I see it why not keep getting up to bat and give it a go – what else is there to do anyway?
Keep at it and good luck,
Dave G
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- February 20, 2012 at 9:09 am
Kevin,
I also tried the Yervoy route with no luck. Then IL2 – again no luck. I'm still hoping that maybe one or both of these treatments kick in late and do some good but I can't wait on that. Going to try another trial in a week and I understand there are others but I need get off this steroid first. The way I see it why not keep getting up to bat and give it a go – what else is there to do anyway?
Keep at it and good luck,
Dave G
-
- February 20, 2012 at 9:09 am
Kevin,
I also tried the Yervoy route with no luck. Then IL2 – again no luck. I'm still hoping that maybe one or both of these treatments kick in late and do some good but I can't wait on that. Going to try another trial in a week and I understand there are others but I need get off this steroid first. The way I see it why not keep getting up to bat and give it a go – what else is there to do anyway?
Keep at it and good luck,
Dave G
-
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- February 20, 2012 at 1:10 pm
I have been thinking and praying for you. Good for you for getting all your information off as soon as possible and I am hopeful they can find a plan for you and can take you.
The positive news is there seems to be more and more trials coming out and one of them will be the winner for you, you are young and strong and such an amazing attitude!!. I do hope the yervoy is just taking it time and will kick in for you.
take care, keep us posted, stay strong!
laurie from maine
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- February 20, 2012 at 1:10 pm
I have been thinking and praying for you. Good for you for getting all your information off as soon as possible and I am hopeful they can find a plan for you and can take you.
The positive news is there seems to be more and more trials coming out and one of them will be the winner for you, you are young and strong and such an amazing attitude!!. I do hope the yervoy is just taking it time and will kick in for you.
take care, keep us posted, stay strong!
laurie from maine
-
- February 20, 2012 at 1:10 pm
I have been thinking and praying for you. Good for you for getting all your information off as soon as possible and I am hopeful they can find a plan for you and can take you.
The positive news is there seems to be more and more trials coming out and one of them will be the winner for you, you are young and strong and such an amazing attitude!!. I do hope the yervoy is just taking it time and will kick in for you.
take care, keep us posted, stay strong!
laurie from maine
-
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- February 20, 2012 at 2:21 pm
Kevin,
I been following a new Clinical trial at the NCI with Rosenberg. It uses modified T-cells to secrete IL-12 into the tumor's miroenviroment. This will shift the T-cell differentiation toward the Th1 phenotype (the good helper cells). This IL-12 also help activate the CD8 T-cell (CTLs) Tumor Killing cells. You might want to see about this one.
I have been studing how to activate the "Danger signal" to help get the immune response started.. It can be done a number of ways but not all have been clinically tested.
You can involke an immune response by the innate immune systems. This entails using the (TLRs) Toll Like receptors.
If you combine the TLR4 and TLR9 actiavtion you can induce an immune response that secretes IL-6,IL-1, TNF and mostly IL-12. If you add PI3K inhibitor in the mix, the outcome is the Th1 T-cells with very few new Tregs. Tregs are suppressive to the immune response.
The bottom line is Rosenberg's Trial is the most cutting edge technology out there.
The second best is the combination of Yervoy and Anti-PD-1. This trial not only knocks out the Treg's function, but also fixes the T-cell exhuastion with Anti-PD-1. The problem here is you still need the "danger signal" to get the T-cells activated and homing to the point of danger, the tumor's microenvirnoment.
I wish you well in your path forward.
Jimmy B
-
- February 20, 2012 at 2:21 pm
Kevin,
I been following a new Clinical trial at the NCI with Rosenberg. It uses modified T-cells to secrete IL-12 into the tumor's miroenviroment. This will shift the T-cell differentiation toward the Th1 phenotype (the good helper cells). This IL-12 also help activate the CD8 T-cell (CTLs) Tumor Killing cells. You might want to see about this one.
I have been studing how to activate the "Danger signal" to help get the immune response started.. It can be done a number of ways but not all have been clinically tested.
You can involke an immune response by the innate immune systems. This entails using the (TLRs) Toll Like receptors.
If you combine the TLR4 and TLR9 actiavtion you can induce an immune response that secretes IL-6,IL-1, TNF and mostly IL-12. If you add PI3K inhibitor in the mix, the outcome is the Th1 T-cells with very few new Tregs. Tregs are suppressive to the immune response.
The bottom line is Rosenberg's Trial is the most cutting edge technology out there.
The second best is the combination of Yervoy and Anti-PD-1. This trial not only knocks out the Treg's function, but also fixes the T-cell exhuastion with Anti-PD-1. The problem here is you still need the "danger signal" to get the T-cells activated and homing to the point of danger, the tumor's microenvirnoment.
I wish you well in your path forward.
Jimmy B
-
- February 20, 2012 at 2:25 pm
Kevin,
I forgot one thing. If you do BRAF, try to get it in combination with MEK inhibitor. Melanoma seems to find its way around the Braf pathway. So blocking both pathways lowers the chances that Melanoma will circumvent the pathways.
Best regards,
Jimmy B
-
- February 20, 2012 at 2:25 pm
Kevin,
I forgot one thing. If you do BRAF, try to get it in combination with MEK inhibitor. Melanoma seems to find its way around the Braf pathway. So blocking both pathways lowers the chances that Melanoma will circumvent the pathways.
Best regards,
Jimmy B
-
- February 20, 2012 at 2:25 pm
Kevin,
I forgot one thing. If you do BRAF, try to get it in combination with MEK inhibitor. Melanoma seems to find its way around the Braf pathway. So blocking both pathways lowers the chances that Melanoma will circumvent the pathways.
Best regards,
Jimmy B
-
- February 20, 2012 at 2:21 pm
Kevin,
I been following a new Clinical trial at the NCI with Rosenberg. It uses modified T-cells to secrete IL-12 into the tumor's miroenviroment. This will shift the T-cell differentiation toward the Th1 phenotype (the good helper cells). This IL-12 also help activate the CD8 T-cell (CTLs) Tumor Killing cells. You might want to see about this one.
I have been studing how to activate the "Danger signal" to help get the immune response started.. It can be done a number of ways but not all have been clinically tested.
You can involke an immune response by the innate immune systems. This entails using the (TLRs) Toll Like receptors.
If you combine the TLR4 and TLR9 actiavtion you can induce an immune response that secretes IL-6,IL-1, TNF and mostly IL-12. If you add PI3K inhibitor in the mix, the outcome is the Th1 T-cells with very few new Tregs. Tregs are suppressive to the immune response.
The bottom line is Rosenberg's Trial is the most cutting edge technology out there.
The second best is the combination of Yervoy and Anti-PD-1. This trial not only knocks out the Treg's function, but also fixes the T-cell exhuastion with Anti-PD-1. The problem here is you still need the "danger signal" to get the T-cells activated and homing to the point of danger, the tumor's microenvirnoment.
I wish you well in your path forward.
Jimmy B
-
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