Immunization With gp100 Protein Vaccine in Treating Patients With Metastatic Melanoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00072085|
Recruitment Status : Completed
First Posted : November 6, 2003
Last Update Posted : June 19, 2013
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: This randomized phase II trial is studying immunization using two different gp100 protein vaccines to compare how well they work in treating patients with metastatic melanoma.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Biological: aldesleukin Biological: gp100 antigen Biological: incomplete Freund's adjuvant||Phase 2|
- Compare the clinical response in patients with metastatic melanoma immunized with recombinant gp100 protein (184V) emulsified in Montanide ISA-51 with or without gp100:209-217 (210M) peptide.
- Compare the toxicity profile of these immunizations in these patients.
OUTLINE: This is a randomized study. Patients are assigned to 1 of 2 cohorts according to HLA-A2*0201 status. Patients assigned to cohort 1 are then randomized to 1 of 2 treatment arms.
Cohort 1 (HLA-A2*0201-positive patients): Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive immunization comprising recombinant gp100 protein (184V) emulsified in Montanide ISA-51 subcutaneously (SC) on days 1, 22, 43, and 64 (1 course).
- Arm II: Patients receive immunization comprising recombinant gp100 protein (184V) and gp100:209-217 (210M) peptide emulsified in Montanide ISA-51 SC on days 1, 22, 43, and 64 (1 course).
- Cohort 2 (HLA-A2*0201-negative patients): Patients receive immunization as in cohort 1, arm I.
In both cohorts, treatment continues in the absence of rapid disease progression or unacceptable toxicity.
In both cohorts, patients are evaluated 3-4 weeks after the fourth immunization. Patients achieving stable disease or a partial response receive retreatment according to their assigned cohort. Patients with progressive disease who are eligible for interleukin-2 (IL-2) receive retreatment according to their assigned cohort AND high-dose IL-2 IV over 15 minutes 3 times daily on days 2-5, 23-26, 44-47, and 65-68 (1 course). Patients receive up to 3 retreatment courses. Patients achieving a complete response (CR) receive 1 retreatment course beyond CR. Patients with progressive disease who are ineligible for IL-2 administration are removed from the study.
PROJECTED ACCRUAL: A total of 45-75 patients (30-50 for cohort 1 [15-25 per treatment arm] and 15-25 for cohort 2) will be accrued for this study within 3 years.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Immunization Of Patients With Metastatic Melanoma Using A Recombinant GP100 Protein (184V) And A Class I Restricted Peptide From The GP100 Antigen|
|Study Start Date :||September 2003|
|Actual Study Completion Date :||July 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00072085
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support|
|Bethesda, Maryland, United States, 20892-1182|
|NCI - Center for Cancer Research|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Steven A. Rosenberg, MD, PhD||NCI - Surgery Branch|