NCT00091338

Interleukin-7 and Vaccine Therapy in Treating Patients With Metastatic Melanoma

A Study of Subcutaneous "CYT 99 007" (Interleukin-7) in Conjunction With Peptide Immunization in Patients With Metastatic Melanoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
BIOLOGICAL	MART-1 antigen
BIOLOGICAL	gp100 antigen
BIOLOGICAL	incomplete Freund's adjuvant
BIOLOGICAL	recombinant interleukin-7

Timeline

• Start date: 2004-08-01
• First posted: 2004-09-09
• Last updated: 2015-04-30

Locations

1 site across 1 country: United States