Interleukin-7 and Vaccine Therapy 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: NCT00091338|
Recruitment Status : Completed
First Posted : September 9, 2004
Last Update Posted : April 30, 2015
RATIONALE: Interleukin-7 may stimulate a person's white blood cells to kill tumor cells. Vaccines made from peptides may make the body build an immune response to kill tumor cells. Combining interleukin-7 with vaccine therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of interleukin-7 when given with vaccine therapy in treating patients with metastatic melanoma.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Biological: MART-1 antigen Biological: gp100 antigen Biological: incomplete Freund's adjuvant Biological: recombinant interleukin-7||Phase 1|
- Determine the maximum tolerated dose of interleukin-7 (IL-7) when administered with melanoma peptide vaccine emulsified in Montanide ISA-51 in patients with metastatic melanoma.
- Determine the safety of this regimen in these patients.
- Determine the biological effects of this regimen on T-cell function and phenotype at various doses and at the optimal biological dose in these patients.
- Determine the pharmacokinetic and pharmacodynamic characteristics of IL-7 in patients treated with this regimen.
- Determine the antitumor effects of IL-7, in terms of a dose-escalation strategy, in these patients.
OUTLINE: This is a dose-escalation study of interleukin-7 (IL-7).
Patients receive IL-7 subcutaneously (SC) on days 0, 3, 6, 9, 12, 15, 18, and 21. Patients also receive melanoma peptide vaccine comprising gp100 antigen and MART-1 antigen emulsified in Montanide ISA-51 SC on days 0, 7, 14, and 21 in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of IL-7 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. After the MTD is determined, an additional 13 patients are treated at that dose level.
Patients are followed at 1, 2, and 5 weeks, at 3 and 6 months, and then at 1 year.
PROJECTED ACCRUAL: A total of 3-37 patients will be accrued for this study within 1-12.3 months.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Study of Subcutaneous "CYT 99 007" (Interleukin-7) in Conjunction With Peptide Immunization in Patients With Metastatic Melanoma|
|Study Start Date :||August 2004|
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): NCT00091338
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support|
|Bethesda, Maryland, United States, 20892-1182|
|Principal Investigator:||Steven A. Rosenberg, MD, PhD||NCI - Surgery Branch|