› Forums › General Melanoma Community › Now I’m Stage IV…and GSK Braf has been pulled???? Help! & Vent-Time.
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P Brown.
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- October 22, 2010 at 9:19 pm
Dear Fellow Mellos;
Just talked with VERY helpful folks at Eastabrooke cancer center in Omaha. They told me the GSK 2118436 B-raf drug trial phase II (NCT 011537630) had been pulled (terminated?) by FDA nationwide. MDAnderson cannot seem to give me an answer at all. I waited 5 long weeks for MDA to lemme know i was B-raf positive. Now my CT scan 2 days ago show 3 Nodules OVER 1 cm. as well as the continued others. I completed 1 yr. I-feron 3 mths. ago.
Dear Fellow Mellos;
Just talked with VERY helpful folks at Eastabrooke cancer center in Omaha. They told me the GSK 2118436 B-raf drug trial phase II (NCT 011537630) had been pulled (terminated?) by FDA nationwide. MDAnderson cannot seem to give me an answer at all. I waited 5 long weeks for MDA to lemme know i was B-raf positive. Now my CT scan 2 days ago show 3 Nodules OVER 1 cm. as well as the continued others. I completed 1 yr. I-feron 3 mths. ago.
Does ANYONE know of a viable active B-raf trial available via GSK, Novartis, Roche, Bayer?, anyplace anywhere?
I know i could get IPI, but i'm just not too impressed with the stats on it- maybe i'm wrong. At least the B-raf drugs showed miraculous results- albeit short term; AND traditional IL-2 shows Proven long term results on around 10% of people. I really wanted to do B-raf drug to at least buy some somewhat guaranteed time.
Any suggestions or trial knowledge greatly appreciated!
Love, Shady-Grady.
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- October 22, 2010 at 11:17 pm
These are all lung nodules BTW. At least 10 with two 1.1 cm on each side of heart (paracardium) and one .9cm next to diaphram. all still technically in lungs.
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- October 23, 2010 at 12:52 am
I think that you have the wrong clinical trial number..I googled that number it does not exit in the data base.
Everyone would be interested in knowing which trial has been pulled.
Please post further/or more info on the trial
Thanks.
good luck with your trial search
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- October 23, 2010 at 4:43 pm
I don't know anything about whether this trial is being terminated or not, but this is the link:
http://www.clinicaltrials.gov/ct2/show/NCT01153763?term=01153763&rank=1
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- October 23, 2010 at 4:43 pm
I don't know anything about whether this trial is being terminated or not, but this is the link:
http://www.clinicaltrials.gov/ct2/show/NCT01153763?term=01153763&rank=1
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- October 23, 2010 at 12:52 am
I think that you have the wrong clinical trial number..I googled that number it does not exit in the data base.
Everyone would be interested in knowing which trial has been pulled.
Please post further/or more info on the trial
Thanks.
good luck with your trial search
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- October 23, 2010 at 11:47 am
I am on the Roche Braf trial. Have you looked into this one?
RO5185426
http://clinicaltrials.gov/show/NCT01006980
I am on vacation right now with my family so I will check back later it you found it.
Love and peace,
Shelly in Switzerland
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- October 23, 2010 at 11:47 am
I am on the Roche Braf trial. Have you looked into this one?
RO5185426
http://clinicaltrials.gov/show/NCT01006980
I am on vacation right now with my family so I will check back later it you found it.
Love and peace,
Shelly in Switzerland
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- October 23, 2010 at 11:49 am
I dont know what happened on that message. I am typing on a keyboard in Italy and it is ALL confusing.
At the bottom of that blob is the gov. trial number.
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- October 23, 2010 at 11:49 am
I dont know what happened on that message. I am typing on a keyboard in Italy and it is ALL confusing.
At the bottom of that blob is the gov. trial number.
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- October 23, 2010 at 12:25 pm
Thanks Shelly- Yes I have looked at this one. However, it is randomised correct? meaning of course you have a 1/3 or more chance of NOT getting B-raf drug. I do not like this. Correct me please if i am wrong- that would be great!
Love from the Swamps, Grady.
PS- Hoffman/LaRoche has 1 trial in Zurich= NCT 01164891 ; US study # NP25158.
Would love to find excuse to go back to Switz.!
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- October 23, 2010 at 12:25 pm
Thanks Shelly- Yes I have looked at this one. However, it is randomised correct? meaning of course you have a 1/3 or more chance of NOT getting B-raf drug. I do not like this. Correct me please if i am wrong- that would be great!
Love from the Swamps, Grady.
PS- Hoffman/LaRoche has 1 trial in Zurich= NCT 01164891 ; US study # NP25158.
Would love to find excuse to go back to Switz.!
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- October 23, 2010 at 4:53 pm
Grady where do you live??? What location site was the BRAF clinical trial you were going to participatebefore it got terminated??????? Who told you the FDA terminated this braf trial???
Has anyone else been told of this FDA termination of this BRAF trial??
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- October 23, 2010 at 4:53 pm
Grady where do you live??? What location site was the BRAF clinical trial you were going to participatebefore it got terminated??????? Who told you the FDA terminated this braf trial???
Has anyone else been told of this FDA termination of this BRAF trial??
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- October 23, 2010 at 4:52 pm
Hi There! Check in with Sara Cannon, Nashville. My brother is there taking GSK Braf- after nine months doing great! They also have several other trials starting up.
Best of luck!
MrsMarilyn
sister of Gary Stage (iv)
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- October 23, 2010 at 9:34 pm
Thank You MrsMarilyn. Actually, funny you mention Sarah Cannon- because when i talked with Estabroke in Omaha place to check on the B-raf GSK drug trial- which they did say was cnacelled or no longer available there at least (i know i'm not THAT crazy!)- they, the person in Omaha, recommended S. Cannon as a possibility for trials.
I'm so scared of saying something wrong or misleading at this pt…..but….i would like to ask about your brother, his trial, and perhaps the contact/Dr. that helped you at S. Cannon. My email is: [email protected] if you feel comfortable sending me an "OK" so i could ask some things. I'm finding out a lot of mixed-up contadictory info. re. the specific NON-randomised trial of GSK drug 2118436 and trial # NCT 01153763. I assume this is the one your brother is on?
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- October 24, 2010 at 4:52 pm
I've talked to the SC people before too and they are very nice. If you can't find contact info email me and I'll get you some. I think the 2113458 trials are on hold, or at least not recruiting. I know when I was on it there were no openings. I think they opened a combo with that drug w/ a MEK inhibitor. I was not able to get cleared for it because of my brain mets. No luck finding a PLX trial that would take me either. So I am doing the ipi comp. use and hoping for the best. I started this week in San Antonio.
Good luck and keep me posted on what you find! I know it's frustrating to not be able to get your hands on it. I literally felt my tumors decreasing in size after two days – and they almost completely disappeared and stayed gone 8 months. Short term worth the longer term risk? For me – you bet. But hopefully the ipi will do its job and last long enough that the kinase inhibitor problems / complexities can be resolved.
Love,
Amy
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- October 24, 2010 at 6:21 pm
Thanks so much Amy. I was at MDA on 9-16th and even asked Dr. Wen-Jen Hwu about you – of course they couldn't tell me anything or even acknowledge your existence in this PC/HIPPA/Paranoid world. Where did old fashion common sense go?? ….like i'm there with probable Stage IV MM, slides, records, and my wife – and i might be a stalker ir something??? anyway, yeah i've been a bit bitchy lately (in a manly way of course). Ya gotta laugh about things- its the only thing thats kept me alive even before MM!!!
I knew i'd count on you to understand my frustrations…..you otta know, right?! I hope the best for you re. IPI. Lemme know how THAT goes as i have contemplated that. I assume you may be on the trial where it is combined with Tremador? I'll let ya know about what i "get" from the powers that be….including first and formost God, i reckon.
When you note the "stayed gone 8 months." – what treatment are you refering to?
Love & Take Care- Grady.
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- October 24, 2010 at 6:21 pm
Thanks so much Amy. I was at MDA on 9-16th and even asked Dr. Wen-Jen Hwu about you – of course they couldn't tell me anything or even acknowledge your existence in this PC/HIPPA/Paranoid world. Where did old fashion common sense go?? ….like i'm there with probable Stage IV MM, slides, records, and my wife – and i might be a stalker ir something??? anyway, yeah i've been a bit bitchy lately (in a manly way of course). Ya gotta laugh about things- its the only thing thats kept me alive even before MM!!!
I knew i'd count on you to understand my frustrations…..you otta know, right?! I hope the best for you re. IPI. Lemme know how THAT goes as i have contemplated that. I assume you may be on the trial where it is combined with Tremador? I'll let ya know about what i "get" from the powers that be….including first and formost God, i reckon.
When you note the "stayed gone 8 months." – what treatment are you refering to?
Love & Take Care- Grady.
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- October 24, 2010 at 4:52 pm
I've talked to the SC people before too and they are very nice. If you can't find contact info email me and I'll get you some. I think the 2113458 trials are on hold, or at least not recruiting. I know when I was on it there were no openings. I think they opened a combo with that drug w/ a MEK inhibitor. I was not able to get cleared for it because of my brain mets. No luck finding a PLX trial that would take me either. So I am doing the ipi comp. use and hoping for the best. I started this week in San Antonio.
Good luck and keep me posted on what you find! I know it's frustrating to not be able to get your hands on it. I literally felt my tumors decreasing in size after two days – and they almost completely disappeared and stayed gone 8 months. Short term worth the longer term risk? For me – you bet. But hopefully the ipi will do its job and last long enough that the kinase inhibitor problems / complexities can be resolved.
Love,
Amy
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- October 23, 2010 at 9:34 pm
Thank You MrsMarilyn. Actually, funny you mention Sarah Cannon- because when i talked with Estabroke in Omaha place to check on the B-raf GSK drug trial- which they did say was cnacelled or no longer available there at least (i know i'm not THAT crazy!)- they, the person in Omaha, recommended S. Cannon as a possibility for trials.
I'm so scared of saying something wrong or misleading at this pt…..but….i would like to ask about your brother, his trial, and perhaps the contact/Dr. that helped you at S. Cannon. My email is: [email protected] if you feel comfortable sending me an "OK" so i could ask some things. I'm finding out a lot of mixed-up contadictory info. re. the specific NON-randomised trial of GSK drug 2118436 and trial # NCT 01153763. I assume this is the one your brother is on?
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- October 23, 2010 at 4:52 pm
Hi There! Check in with Sara Cannon, Nashville. My brother is there taking GSK Braf- after nine months doing great! They also have several other trials starting up.
Best of luck!
MrsMarilyn
sister of Gary Stage (iv)
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- October 25, 2010 at 4:14 pm
I did a quick search on the open BRAF trials that are recruiting and found 16 that are recruiting and 1 that is not recruiting.
You may want to look at them to see if you meet any of their criteria.
http://www.clinicalgaltrials.gov
I searchec by Melanoma and BRAF. Good luck.
Rank Status Study 1 Not yet recruiting A Study Comparing GSK2118436 to Dacarbazine (DTIC) in Previously Untreated Subjects With BRAF Mutation Positive Advanced (Stage III) or Metastatic (Stage IV) Melanoma. Conditions: Melanoma; BRAF Mutant Metastatic Melanoma; Cancer Interventions: Drug: GSK2118436; Drug: Dacarbazine (DTIC) 2 Recruiting Study to Determine the Effectiveness of GSK1120212 in BRAF Mutation-positive Melanoma Previously Treated With or Without a BRAF Inhibitor Conditions: Melanoma; Cancer Intervention: Drug: GSK1120212 3 Recruiting A Study of GSK2118436 in BRAF Mutant Metastatic Melanoma Conditions: Melanoma; BRAF Mutant Metastatic Melanoma Intervention: Drug: GSK2118436 4 Recruiting Investigate Safety, Pharmacokinetics and Pharmacodynamics of GSK2118436 & GSK1120212 Condition: Cancer Interventions: Drug: GSK2118436; Drug: GSK1120212 5 Recruiting Temsirolimus/AZD 6244 for Treatment-naive With BRAF Mutant Unresectable Stage IV Condition: Melanoma Interventions: Drug: CCI-779; Drug: AZD6244 6 Recruiting A Study of RO5212054 (PLX3603) in Patients With BRAF V600-mutated Advanced Solid Tumours Condition: Colorectal Cancer, Malignant Melanoma, Neoplasms Intervention: Drug: RO5212054 7 Recruiting A Phase I Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of GSK2118436 in Subjects With Solid Tumors Conditions: Melanoma; Solid Tumor Cancer; Cancer Interventions: Drug: GSK2118436; Drug: Midazolam 8 Recruiting MEK Inhibitor AZD6244 in Treating Patients With Stage III or Stage IV Melanoma Condition: Melanoma (Skin) Interventions: Drug: MEK inhibitor AZD6244; Genetic: gene expression analysis; Genetic: mutation analysis; Genetic: nucleic acid sequencing; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis; Other: matrix-assisted laser desorption/ionization time of flight mass spectrometry 9 Recruiting A Study of RO5185426 in Comparison With Dacarbazine in Previously Untreated Patients With Metastatic Melanoma Condition: Malignant Melanoma Interventions: Drug: RO5185426; Drug: dacarbazine 10 Recruiting Genetic Risk Factors and Acquired Oncogenic Mutations of Melanoma Condition: Melanoma Intervention: 11 Recruiting A Study to Evaluate RAF265, an Oral Drug Administered to Subjects With Locally Advanced or Metastatic Melanoma Condition: Metastatic Melanoma Intervention: Drug: RAF265 12 Recruiting AZD6244 in Cancers With BRAF Mutations Condition: BRAF Mutation Cancer Intervention: Drug: AZD6244 13 Recruiting Study of TAK-733 in Adult Patients With Advanced Nonhematologic Malignancies Conditions: Advanced Non-hematologic Malignancies; Advanced Metastatic Melanoma Intervention: Drug: TAK-733 14 Recruiting An Open-Label, 2-Cohort, Multicenter, Study of E7080 in Previously Treated Subjects With Unresectable Stage III or Stage IV Melanoma Condition: Unresectable Stage III or Stage IV Melanoma Intervention: Drug: E7080 15 Recruiting Study of Tumor Tissue Samples From Patients With Stage I, Stage II, or Stage III Malignant Melanoma Condition: Melanoma (Skin) Interventions: Genetic: gene expression analysis; Genetic: polymerase chain reaction; Genetic: polymorphism analysis; Other: matrix-assisted laser desorption/ionization time of flight mass spectrometry; Other: medical chart review 16 Recruiting Study of XL281 in Adults With Solid Tumors Conditions: Cancer; Non-Small-Cell Lung Cancer; Colorectal Cancer; Papillary Thyroid Cancer; Melanoma Interventions: Drug: XL281; Drug: famotidine 17 Not yet recruiting Genetic Identification (ID) of Segmental Dysplastic Nevi Condition: Segmental Dysplastic Nevi Intervention: Procedure: Punch Biopsy -
- October 25, 2010 at 4:14 pm
I did a quick search on the open BRAF trials that are recruiting and found 16 that are recruiting and 1 that is not recruiting.
You may want to look at them to see if you meet any of their criteria.
http://www.clinicalgaltrials.gov
I searchec by Melanoma and BRAF. Good luck.
Rank Status Study 1 Not yet recruiting A Study Comparing GSK2118436 to Dacarbazine (DTIC) in Previously Untreated Subjects With BRAF Mutation Positive Advanced (Stage III) or Metastatic (Stage IV) Melanoma. Conditions: Melanoma; BRAF Mutant Metastatic Melanoma; Cancer Interventions: Drug: GSK2118436; Drug: Dacarbazine (DTIC) 2 Recruiting Study to Determine the Effectiveness of GSK1120212 in BRAF Mutation-positive Melanoma Previously Treated With or Without a BRAF Inhibitor Conditions: Melanoma; Cancer Intervention: Drug: GSK1120212 3 Recruiting A Study of GSK2118436 in BRAF Mutant Metastatic Melanoma Conditions: Melanoma; BRAF Mutant Metastatic Melanoma Intervention: Drug: GSK2118436 4 Recruiting Investigate Safety, Pharmacokinetics and Pharmacodynamics of GSK2118436 & GSK1120212 Condition: Cancer Interventions: Drug: GSK2118436; Drug: GSK1120212 5 Recruiting Temsirolimus/AZD 6244 for Treatment-naive With BRAF Mutant Unresectable Stage IV Condition: Melanoma Interventions: Drug: CCI-779; Drug: AZD6244 6 Recruiting A Study of RO5212054 (PLX3603) in Patients With BRAF V600-mutated Advanced Solid Tumours Condition: Colorectal Cancer, Malignant Melanoma, Neoplasms Intervention: Drug: RO5212054 7 Recruiting A Phase I Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of GSK2118436 in Subjects With Solid Tumors Conditions: Melanoma; Solid Tumor Cancer; Cancer Interventions: Drug: GSK2118436; Drug: Midazolam 8 Recruiting MEK Inhibitor AZD6244 in Treating Patients With Stage III or Stage IV Melanoma Condition: Melanoma (Skin) Interventions: Drug: MEK inhibitor AZD6244; Genetic: gene expression analysis; Genetic: mutation analysis; Genetic: nucleic acid sequencing; Other: immunohistochemistry staining method; Other: laboratory biomarker analysis; Other: matrix-assisted laser desorption/ionization time of flight mass spectrometry 9 Recruiting A Study of RO5185426 in Comparison With Dacarbazine in Previously Untreated Patients With Metastatic Melanoma Condition: Malignant Melanoma Interventions: Drug: RO5185426; Drug: dacarbazine 10 Recruiting Genetic Risk Factors and Acquired Oncogenic Mutations of Melanoma Condition: Melanoma Intervention: 11 Recruiting A Study to Evaluate RAF265, an Oral Drug Administered to Subjects With Locally Advanced or Metastatic Melanoma Condition: Metastatic Melanoma Intervention: Drug: RAF265 12 Recruiting AZD6244 in Cancers With BRAF Mutations Condition: BRAF Mutation Cancer Intervention: Drug: AZD6244 13 Recruiting Study of TAK-733 in Adult Patients With Advanced Nonhematologic Malignancies Conditions: Advanced Non-hematologic Malignancies; Advanced Metastatic Melanoma Intervention: Drug: TAK-733 14 Recruiting An Open-Label, 2-Cohort, Multicenter, Study of E7080 in Previously Treated Subjects With Unresectable Stage III or Stage IV Melanoma Condition: Unresectable Stage III or Stage IV Melanoma Intervention: Drug: E7080 15 Recruiting Study of Tumor Tissue Samples From Patients With Stage I, Stage II, or Stage III Malignant Melanoma Condition: Melanoma (Skin) Interventions: Genetic: gene expression analysis; Genetic: polymerase chain reaction; Genetic: polymorphism analysis; Other: matrix-assisted laser desorption/ionization time of flight mass spectrometry; Other: medical chart review 16 Recruiting Study of XL281 in Adults With Solid Tumors Conditions: Cancer; Non-Small-Cell Lung Cancer; Colorectal Cancer; Papillary Thyroid Cancer; Melanoma Interventions: Drug: XL281; Drug: famotidine 17 Not yet recruiting Genetic Identification (ID) of Segmental Dysplastic Nevi Condition: Segmental Dysplastic Nevi Intervention: Procedure: Punch Biopsy
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