Melanoma (Skin) Clinical Trial
Official title:
Phase I/II Study of Immunization With MAGE-3 Peptide-Pulsed Autologous PBMC Plus rhIL-12 in Patients With Metastatic Melanoma
RATIONALE: Vaccines made from a tumor antigen gene may make the body build an immune
response to kill tumor cells. Interleukin-12 may kill tumor cells by stopping blood flow to
the tumor and by stimulating a person's white blood cell to kill melanoma cells. Combining
vaccine therapy with interleukin-12 may kill more melanoma cells.
PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy plus interleukin-12
in treating patients who have metastatic melanoma.
OBJECTIVES: I. Determine the safety and maximum tolerated dose level of the vaccine
consisting of MAGE-3 or Melan-A (human tumor antigen genes) peptide-pulsed autologous
peripheral blood mononuclear cells plus interleukin-12. II. Determine if the procedure
results in successful immunization. III. Assess the response of the tumor to the vaccine.
OUTLINE: This is an open label, nonrandomized, single institution study. Patients receive 3
initial courses of treatment consisting of 21 days each. Treatment consists of an
immunization with MAGE-3 or Melan-A peptide-loaded autologous PBMC and interleukin-12
(IL-12) on the first day, IL-12 on days 3 and 5, and 16 days of rest. The first cohort is
not administered IL-12 and the next cohorts are given escalating doses of IL-12. The Phase
II dose will be one dose level below the MTD. Patients who have a tumor remission response
or stable disease may continue treatment for up to one year. Phase I completed as of
04/1999. Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 34 patients will be accrued for this study.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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