Vaccine Therapy and Interleukin-12 in Treating 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.
Biological: MART-1 antigen
Biological: recombinant MAGE-3.1 antigen
Biological: recombinant interleukin-12
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Study of Immunization With MAGE-3 Peptide-Pulsed Autologous PBMC Plus rhIL-12 in Patients With Metastatic Melanoma|
- Clinical Response Rate [ Time Frame: 4 years ] [ Designated as safety issue: No ]
|Study Start Date:||January 1997|
|Study Completion Date:||November 2002|
|Primary Completion Date:||August 2002 (Final data collection date for primary outcome measure)|
Experimental: Arm A
Melan-A peptide loaded PBMCs (sc, q3wk x 3), rhIL-12 (4 mcg, sc, days 1, 3 and 5 of every 3 wk cycle)
Biological: MART-1 antigen
Melan-A peptide loaded PBMCs (sc, q3wk x 3)Biological: recombinant MAGE-3.1 antigen
Other Name: Melan-A peptide loaded PBMCs (sc, q3wk x 3)Biological: recombinant interleukin-12
rhIL-12 (4 mcg, sc, days 1, 3 and 5 of every 3 wk cycle)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002952
|United States, Illinois|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637|
|Study Chair:||Thomas F. Gajewski, MD, PhD||University of Chicago|