› Forums › General Melanoma Community › New Trial for Stages II and III
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mikengineer2.
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- August 3, 2012 at 5:49 pm
Thanks for this info – I looked it up
http://www.clinicaltrials.gov/ct2/show/NCT01546571?term=POL-103A&rank=1
CriteriaInclusion Criteria:
- Histologically confirmed Stage IIb, IIc, III melanoma
- Surgical resection within 90 days of first dosing
- Persons with positive sentinel nodes must have a complete lymphadenectomy
- ECOG performance status 0 or 1
Exclusion Criteria:
- Any prior melanoma treatment other than surgery or regional irradiation
- Diagnosis of non-cutaneous melanoma or melanoma with unknown primary origin
- Use of biologic response modifiers within 60 days of first dosing
- Subjects with history of other malignancy within past 5 years (with exceptions)
LocationsUnited States, California The Angeles Clinic and Research Institute Recruiting Los Angeles, California, United States, 90025 Contact: Saba Mukarram 310-582-7900 Principal Investigator: Omid Hamid, MD United States, Florida Mount Sinai Medical Center Recruiting Miami Beach, Florida, United States, 33140 Contact: Yvonne Enriquez-Nunez 305-674-2625 Principal Investigator: Jose Lutzky, MD MD Anderson Cancer Center-Orlando Recruiting Orlando, Florida, United States, 32806 Contact: Jean Edwards 321-841-6653 Principal Investigator: Gregory Pennock, MD Ameriderm Research Recruiting Ormond Beach, Florida, United States, 32174 Contact: Jody Wheeler 386-898-0547 Principal Investigator: James Solomon, MD United States, Illinois Oncology Specialists, SC (OSSC) Recruiting Niles, Illinois, United States, 60714 Contact: Kathy Tolzein 847-410-0658 Principal Investigator: Jon Richards, MD United States, Indiana Investigative Clinical Research of Indiana Recruiting Indianapolis, Indiana, United States, 46254 Contact: Leslie Weitman 317-297-2208 Principal Investigator: Stephen Schultz, MD United States, Kentucky Central Kentucky Research Associates Recruiting Lexington, Kentucky, United States, 40509 Contact: Susan Lanthorn 859-977-7144 Principal Investigator: James Borders, MD Central Baptist Hospital Recruiting Lexington, Kentucky, United States, 40503 Contact: Heather Tudor 859-260-3196 Principal Investigator: Peter Tate, MD United States, Missouri Center for Pharmaceutical Research Recruiting Kansas City, Missouri, United States, 64114 Contact: Missy MacPhail 816-943-0770 Principal Investigator: John Ervin, MD Washington University School of Medicine Recruiting St. Louis, Missouri, United States, 63110 Contact: Chloe Fournier 314-747-4235 Principal Investigator: Gerald Linette, MD United States, New Hampshire Norris Cotton Cancer Center / Dartmouth-Hitchcock Medical Center Recruiting Lebanon, New Hampshire, United States, 03756 Contact: Eryn Bagley 603-650-4035 Principal Investigator: Marc Ernstoff, MD United States, New Jersey John Theurer Cancer Center Recruiting Hackensack, New Jersey, United States, 07601 Contact: Danielle Blair, RN, BSN, OCN 201-996-5809 Principal Investigator: Andrew Pecora, MD United States, North Carolina Wake Forest University School of Medicine, Comprehensive Cancer Center Recruiting Winston-Salem, North Carolina, United States, 27157 Contact: Joyce Fenstermaker, RN 336-713-3155 Principal Investigator: Edward Levine, MD United States, Pennsylvania Kimmel Cancer Center at Thomas Jefferson Univ. Recruiting Philadelphia, Pennsylvania, United States, 19107 Contact: Mary Ann Laudadio 215-955-9980 Principal Investigator: Kendra Feeney, MD United States, Texas Research Across America Recruiting Dallas, Texas, United States, 75234 Contact: Enrique Echaniz Contact 972 492 6990 ext 135 Principal Investigator: Jeffrey Adelglass, MD Dallas Surgical Group Recruiting Dallas, Texas, United States, 75230 Contact: Tiffany Huber 972-566-4143 Principal Investigator: Peter Beitsch, MD United States, Utah Intermountain Medical Center Recruiting Murray, Utah, United States, 84107 Contact: Tricia Fullmer 801-408-3887 Principal Investigator: Tawnya Bowles, MD The Huntsman Cancer Institute, University of Utah Recruiting Salt Lake City, Utah, United States, 84112-5550 Contact: Jennifer Demko 801-587-4342 Principal Investigator: Robert Andtbacka, MD United States, Virginia Clinical Research Associates of Tidewater Recruiting Norfolk, Virginia, United States, 23507 Contact: Edith Wombolt 757-627-7446 Principal Investigator: Duane Wombolt, MD Sponsors and CollaboratorsPolynoma LLC -
- August 3, 2012 at 5:49 pm
Thanks for this info – I looked it up
http://www.clinicaltrials.gov/ct2/show/NCT01546571?term=POL-103A&rank=1
CriteriaInclusion Criteria:
- Histologically confirmed Stage IIb, IIc, III melanoma
- Surgical resection within 90 days of first dosing
- Persons with positive sentinel nodes must have a complete lymphadenectomy
- ECOG performance status 0 or 1
Exclusion Criteria:
- Any prior melanoma treatment other than surgery or regional irradiation
- Diagnosis of non-cutaneous melanoma or melanoma with unknown primary origin
- Use of biologic response modifiers within 60 days of first dosing
- Subjects with history of other malignancy within past 5 years (with exceptions)
LocationsUnited States, California The Angeles Clinic and Research Institute Recruiting Los Angeles, California, United States, 90025 Contact: Saba Mukarram 310-582-7900 Principal Investigator: Omid Hamid, MD United States, Florida Mount Sinai Medical Center Recruiting Miami Beach, Florida, United States, 33140 Contact: Yvonne Enriquez-Nunez 305-674-2625 Principal Investigator: Jose Lutzky, MD MD Anderson Cancer Center-Orlando Recruiting Orlando, Florida, United States, 32806 Contact: Jean Edwards 321-841-6653 Principal Investigator: Gregory Pennock, MD Ameriderm Research Recruiting Ormond Beach, Florida, United States, 32174 Contact: Jody Wheeler 386-898-0547 Principal Investigator: James Solomon, MD United States, Illinois Oncology Specialists, SC (OSSC) Recruiting Niles, Illinois, United States, 60714 Contact: Kathy Tolzein 847-410-0658 Principal Investigator: Jon Richards, MD United States, Indiana Investigative Clinical Research of Indiana Recruiting Indianapolis, Indiana, United States, 46254 Contact: Leslie Weitman 317-297-2208 Principal Investigator: Stephen Schultz, MD United States, Kentucky Central Kentucky Research Associates Recruiting Lexington, Kentucky, United States, 40509 Contact: Susan Lanthorn 859-977-7144 Principal Investigator: James Borders, MD Central Baptist Hospital Recruiting Lexington, Kentucky, United States, 40503 Contact: Heather Tudor 859-260-3196 Principal Investigator: Peter Tate, MD United States, Missouri Center for Pharmaceutical Research Recruiting Kansas City, Missouri, United States, 64114 Contact: Missy MacPhail 816-943-0770 Principal Investigator: John Ervin, MD Washington University School of Medicine Recruiting St. Louis, Missouri, United States, 63110 Contact: Chloe Fournier 314-747-4235 Principal Investigator: Gerald Linette, MD United States, New Hampshire Norris Cotton Cancer Center / Dartmouth-Hitchcock Medical Center Recruiting Lebanon, New Hampshire, United States, 03756 Contact: Eryn Bagley 603-650-4035 Principal Investigator: Marc Ernstoff, MD United States, New Jersey John Theurer Cancer Center Recruiting Hackensack, New Jersey, United States, 07601 Contact: Danielle Blair, RN, BSN, OCN 201-996-5809 Principal Investigator: Andrew Pecora, MD United States, North Carolina Wake Forest University School of Medicine, Comprehensive Cancer Center Recruiting Winston-Salem, North Carolina, United States, 27157 Contact: Joyce Fenstermaker, RN 336-713-3155 Principal Investigator: Edward Levine, MD United States, Pennsylvania Kimmel Cancer Center at Thomas Jefferson Univ. Recruiting Philadelphia, Pennsylvania, United States, 19107 Contact: Mary Ann Laudadio 215-955-9980 Principal Investigator: Kendra Feeney, MD United States, Texas Research Across America Recruiting Dallas, Texas, United States, 75234 Contact: Enrique Echaniz Contact 972 492 6990 ext 135 Principal Investigator: Jeffrey Adelglass, MD Dallas Surgical Group Recruiting Dallas, Texas, United States, 75230 Contact: Tiffany Huber 972-566-4143 Principal Investigator: Peter Beitsch, MD United States, Utah Intermountain Medical Center Recruiting Murray, Utah, United States, 84107 Contact: Tricia Fullmer 801-408-3887 Principal Investigator: Tawnya Bowles, MD The Huntsman Cancer Institute, University of Utah Recruiting Salt Lake City, Utah, United States, 84112-5550 Contact: Jennifer Demko 801-587-4342 Principal Investigator: Robert Andtbacka, MD United States, Virginia Clinical Research Associates of Tidewater Recruiting Norfolk, Virginia, United States, 23507 Contact: Edith Wombolt 757-627-7446 Principal Investigator: Duane Wombolt, MD Sponsors and CollaboratorsPolynoma LLC-
- December 25, 2012 at 6:40 pm
I have just been accepted into the POL-103A Trial. I too had a right upper arm deep melanoma and am doing very well. N.E.D. but a high risk due to Irish whiteness, toxin exposure and sunlight burns as a child. The quick response at the UMDNJ and the Cancer Center at Hackensack may have very well saved my life. I had a 2mm diameter mole on the right upper arm that I tore off in some sticker bushes. It got ugly and I went to the derma. It was in the over 4.00 deep stage and I was moved very quickly through the oncology system at University Hospital in Newark, N.J. The efficiency, expertise and overall caring at this huge facility still amazes me ! The POL-103A trial was not available at this facility and I was referred to the John Theurer Cancer Center at Hackensack University Hospital for the trial.
I am wondering what, if any side effects anyone has encountered as they progress through the trial.
Thanks, Merry Christmas !
Mike
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- December 25, 2012 at 7:35 pm
No noticeable side effects. Injection sites show little redness or swelling after a few hours. Then I could be receiving the placebo. Waiting until enough patients are enrolled (think they require 90) through 10 weeks to unmask. The amount of medical following for now is the benefit. Lots and lots of blood work plus I am scheduled for more MRI's, and CT scan's Jan 2. They pick up the tab. Hoping they show nothing.
-
- December 25, 2012 at 7:35 pm
No noticeable side effects. Injection sites show little redness or swelling after a few hours. Then I could be receiving the placebo. Waiting until enough patients are enrolled (think they require 90) through 10 weeks to unmask. The amount of medical following for now is the benefit. Lots and lots of blood work plus I am scheduled for more MRI's, and CT scan's Jan 2. They pick up the tab. Hoping they show nothing.
-
- December 25, 2012 at 7:35 pm
No noticeable side effects. Injection sites show little redness or swelling after a few hours. Then I could be receiving the placebo. Waiting until enough patients are enrolled (think they require 90) through 10 weeks to unmask. The amount of medical following for now is the benefit. Lots and lots of blood work plus I am scheduled for more MRI's, and CT scan's Jan 2. They pick up the tab. Hoping they show nothing.
-
- December 25, 2012 at 6:40 pm
I have just been accepted into the POL-103A Trial. I too had a right upper arm deep melanoma and am doing very well. N.E.D. but a high risk due to Irish whiteness, toxin exposure and sunlight burns as a child. The quick response at the UMDNJ and the Cancer Center at Hackensack may have very well saved my life. I had a 2mm diameter mole on the right upper arm that I tore off in some sticker bushes. It got ugly and I went to the derma. It was in the over 4.00 deep stage and I was moved very quickly through the oncology system at University Hospital in Newark, N.J. The efficiency, expertise and overall caring at this huge facility still amazes me ! The POL-103A trial was not available at this facility and I was referred to the John Theurer Cancer Center at Hackensack University Hospital for the trial.
I am wondering what, if any side effects anyone has encountered as they progress through the trial.
Thanks, Merry Christmas !
Mike
-
- December 25, 2012 at 6:40 pm
I have just been accepted into the POL-103A Trial. I too had a right upper arm deep melanoma and am doing very well. N.E.D. but a high risk due to Irish whiteness, toxin exposure and sunlight burns as a child. The quick response at the UMDNJ and the Cancer Center at Hackensack may have very well saved my life. I had a 2mm diameter mole on the right upper arm that I tore off in some sticker bushes. It got ugly and I went to the derma. It was in the over 4.00 deep stage and I was moved very quickly through the oncology system at University Hospital in Newark, N.J. The efficiency, expertise and overall caring at this huge facility still amazes me ! The POL-103A trial was not available at this facility and I was referred to the John Theurer Cancer Center at Hackensack University Hospital for the trial.
I am wondering what, if any side effects anyone has encountered as they progress through the trial.
Thanks, Merry Christmas !
Mike
-
- August 3, 2012 at 5:49 pm
Thanks for this info – I looked it up
http://www.clinicaltrials.gov/ct2/show/NCT01546571?term=POL-103A&rank=1
CriteriaInclusion Criteria:
- Histologically confirmed Stage IIb, IIc, III melanoma
- Surgical resection within 90 days of first dosing
- Persons with positive sentinel nodes must have a complete lymphadenectomy
- ECOG performance status 0 or 1
Exclusion Criteria:
- Any prior melanoma treatment other than surgery or regional irradiation
- Diagnosis of non-cutaneous melanoma or melanoma with unknown primary origin
- Use of biologic response modifiers within 60 days of first dosing
- Subjects with history of other malignancy within past 5 years (with exceptions)
LocationsUnited States, California The Angeles Clinic and Research Institute Recruiting Los Angeles, California, United States, 90025 Contact: Saba Mukarram 310-582-7900 Principal Investigator: Omid Hamid, MD United States, Florida Mount Sinai Medical Center Recruiting Miami Beach, Florida, United States, 33140 Contact: Yvonne Enriquez-Nunez 305-674-2625 Principal Investigator: Jose Lutzky, MD MD Anderson Cancer Center-Orlando Recruiting Orlando, Florida, United States, 32806 Contact: Jean Edwards 321-841-6653 Principal Investigator: Gregory Pennock, MD Ameriderm Research Recruiting Ormond Beach, Florida, United States, 32174 Contact: Jody Wheeler 386-898-0547 Principal Investigator: James Solomon, MD United States, Illinois Oncology Specialists, SC (OSSC) Recruiting Niles, Illinois, United States, 60714 Contact: Kathy Tolzein 847-410-0658 Principal Investigator: Jon Richards, MD United States, Indiana Investigative Clinical Research of Indiana Recruiting Indianapolis, Indiana, United States, 46254 Contact: Leslie Weitman 317-297-2208 Principal Investigator: Stephen Schultz, MD United States, Kentucky Central Kentucky Research Associates Recruiting Lexington, Kentucky, United States, 40509 Contact: Susan Lanthorn 859-977-7144 Principal Investigator: James Borders, MD Central Baptist Hospital Recruiting Lexington, Kentucky, United States, 40503 Contact: Heather Tudor 859-260-3196 Principal Investigator: Peter Tate, MD United States, Missouri Center for Pharmaceutical Research Recruiting Kansas City, Missouri, United States, 64114 Contact: Missy MacPhail 816-943-0770 Principal Investigator: John Ervin, MD Washington University School of Medicine Recruiting St. Louis, Missouri, United States, 63110 Contact: Chloe Fournier 314-747-4235 Principal Investigator: Gerald Linette, MD United States, New Hampshire Norris Cotton Cancer Center / Dartmouth-Hitchcock Medical Center Recruiting Lebanon, New Hampshire, United States, 03756 Contact: Eryn Bagley 603-650-4035 Principal Investigator: Marc Ernstoff, MD United States, New Jersey John Theurer Cancer Center Recruiting Hackensack, New Jersey, United States, 07601 Contact: Danielle Blair, RN, BSN, OCN 201-996-5809 Principal Investigator: Andrew Pecora, MD United States, North Carolina Wake Forest University School of Medicine, Comprehensive Cancer Center Recruiting Winston-Salem, North Carolina, United States, 27157 Contact: Joyce Fenstermaker, RN 336-713-3155 Principal Investigator: Edward Levine, MD United States, Pennsylvania Kimmel Cancer Center at Thomas Jefferson Univ. Recruiting Philadelphia, Pennsylvania, United States, 19107 Contact: Mary Ann Laudadio 215-955-9980 Principal Investigator: Kendra Feeney, MD United States, Texas Research Across America Recruiting Dallas, Texas, United States, 75234 Contact: Enrique Echaniz Contact 972 492 6990 ext 135 Principal Investigator: Jeffrey Adelglass, MD Dallas Surgical Group Recruiting Dallas, Texas, United States, 75230 Contact: Tiffany Huber 972-566-4143 Principal Investigator: Peter Beitsch, MD United States, Utah Intermountain Medical Center Recruiting Murray, Utah, United States, 84107 Contact: Tricia Fullmer 801-408-3887 Principal Investigator: Tawnya Bowles, MD The Huntsman Cancer Institute, University of Utah Recruiting Salt Lake City, Utah, United States, 84112-5550 Contact: Jennifer Demko 801-587-4342 Principal Investigator: Robert Andtbacka, MD United States, Virginia Clinical Research Associates of Tidewater Recruiting Norfolk, Virginia, United States, 23507 Contact: Edith Wombolt 757-627-7446 Principal Investigator: Duane Wombolt, MD Sponsors and CollaboratorsPolynoma LLC -
- December 8, 2012 at 6:10 pm
I am currently enrolled in the POL-103a trial. Started in June. I had a excision of the melanoma in the upper right arm. with a 0.81-mm thick lesion extending to Clark level IV. One mitosis present per mm2. A Sentinel biopsy was performed which showed a small amount of residual melanoma in situ in the wide excision specimen. A solitary right axillary SLN demonstarated clear-cut metastasis. Staging set at IIIA
The right axilla lymph odes were excised in April and a subsequent PTscan indicated n further sites.
The choice was interfuron but after consultation with three independent oncologists and at 72 years of age although in excellent health I decided not to go that route but to watch carefully.
I started the Trial in June. The trial did extensive pre trial testing. MRI's, CTScan, eye exam and extensive blood work before acceptance. time consuming and expensive if you were not in a trial. So there were additional benefits. Received 4 injections two weeks apart for the first 10 weeks along with extensive blood work, EKG's and physical inspection.
Now going once every 4 weeks for 3 months and then every three months. I am scheduled for additional MRI, CT Scan and Eye exam.
There is little to no reaction from the drug or placebo. Just a short skin irritation for the first 6-10 hours. Then again, I might be receiving the placebo. I also see my Oncologist for testing on a three month basis.
In my situation I preferred to go the no interfuron route for side effect reasons and to microscopy my condition???
Would be interested in any other patients in the study.
-
- December 8, 2012 at 6:10 pm
I am currently enrolled in the POL-103a trial. Started in June. I had a excision of the melanoma in the upper right arm. with a 0.81-mm thick lesion extending to Clark level IV. One mitosis present per mm2. A Sentinel biopsy was performed which showed a small amount of residual melanoma in situ in the wide excision specimen. A solitary right axillary SLN demonstarated clear-cut metastasis. Staging set at IIIA
The right axilla lymph odes were excised in April and a subsequent PTscan indicated n further sites.
The choice was interfuron but after consultation with three independent oncologists and at 72 years of age although in excellent health I decided not to go that route but to watch carefully.
I started the Trial in June. The trial did extensive pre trial testing. MRI's, CTScan, eye exam and extensive blood work before acceptance. time consuming and expensive if you were not in a trial. So there were additional benefits. Received 4 injections two weeks apart for the first 10 weeks along with extensive blood work, EKG's and physical inspection.
Now going once every 4 weeks for 3 months and then every three months. I am scheduled for additional MRI, CT Scan and Eye exam.
There is little to no reaction from the drug or placebo. Just a short skin irritation for the first 6-10 hours. Then again, I might be receiving the placebo. I also see my Oncologist for testing on a three month basis.
In my situation I preferred to go the no interfuron route for side effect reasons and to microscopy my condition???
Would be interested in any other patients in the study.
-
- December 8, 2012 at 6:10 pm
I am currently enrolled in the POL-103a trial. Started in June. I had a excision of the melanoma in the upper right arm. with a 0.81-mm thick lesion extending to Clark level IV. One mitosis present per mm2. A Sentinel biopsy was performed which showed a small amount of residual melanoma in situ in the wide excision specimen. A solitary right axillary SLN demonstarated clear-cut metastasis. Staging set at IIIA
The right axilla lymph odes were excised in April and a subsequent PTscan indicated n further sites.
The choice was interfuron but after consultation with three independent oncologists and at 72 years of age although in excellent health I decided not to go that route but to watch carefully.
I started the Trial in June. The trial did extensive pre trial testing. MRI's, CTScan, eye exam and extensive blood work before acceptance. time consuming and expensive if you were not in a trial. So there were additional benefits. Received 4 injections two weeks apart for the first 10 weeks along with extensive blood work, EKG's and physical inspection.
Now going once every 4 weeks for 3 months and then every three months. I am scheduled for additional MRI, CT Scan and Eye exam.
There is little to no reaction from the drug or placebo. Just a short skin irritation for the first 6-10 hours. Then again, I might be receiving the placebo. I also see my Oncologist for testing on a three month basis.
In my situation I preferred to go the no interfuron route for side effect reasons and to microscopy my condition???
Would be interested in any other patients in the study.
-
- December 26, 2012 at 1:28 am
Am interested in Halcur's upper arm excision. My incision looks like a shark bite, about 30+ sutures. It starts 3" above my elbow to 3" below my right shoulder and back across/down to about 6" above the elbow. Looks like a shark fin. It healed very well in a short time ( 3 weeks) with no grafting. Stretched tight but look ok. (relevant). I also decided that the Inteferon was not a viable solution as this trial has greater end potential. Does anyone know if the Inteferon is now synthetically derived, or is continued to be extracted from apricot pits.
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- December 26, 2012 at 1:28 am
Am interested in Halcur's upper arm excision. My incision looks like a shark bite, about 30+ sutures. It starts 3" above my elbow to 3" below my right shoulder and back across/down to about 6" above the elbow. Looks like a shark fin. It healed very well in a short time ( 3 weeks) with no grafting. Stretched tight but look ok. (relevant). I also decided that the Inteferon was not a viable solution as this trial has greater end potential. Does anyone know if the Inteferon is now synthetically derived, or is continued to be extracted from apricot pits.
-
- December 26, 2012 at 1:28 am
Am interested in Halcur's upper arm excision. My incision looks like a shark bite, about 30+ sutures. It starts 3" above my elbow to 3" below my right shoulder and back across/down to about 6" above the elbow. Looks like a shark fin. It healed very well in a short time ( 3 weeks) with no grafting. Stretched tight but look ok. (relevant). I also decided that the Inteferon was not a viable solution as this trial has greater end potential. Does anyone know if the Inteferon is now synthetically derived, or is continued to be extracted from apricot pits.
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