Vaccine Therapy and Interleukin-12 in Treating Patients With Metastatic Melanoma
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|ClinicalTrials.gov Identifier: NCT00002952|
Recruitment Status : Completed
First Posted : April 22, 2004
Last Update Posted : September 5, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Biological: MART-1 antigen Biological: recombinant MAGE-3.1 antigen Biological: recombinant interleukin-12||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of Immunization With MAGE-3 Peptide-Pulsed Autologous PBMC Plus rhIL-12 in Patients With Metastatic Melanoma|
|Study Start Date :||January 1997|
|Actual Primary Completion Date :||August 2002|
|Actual Study Completion Date :||November 2002|
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)
- Clinical Response Rate [ Time Frame: 4 years ]
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): 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|