Melanoma (Skin) Clinical Trial
Official title:
A Study of Subcutaneous "CYT 99 007" (Interleukin-7) in Conjunction With Peptide Immunization in Patients With Metastatic Melanoma
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.
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
;
Primary Purpose: Treatment
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