Expired Study
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Chicago, Illinois 60637


Purpose:

RATIONALE: Vaccines 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. Interleukin-2 and interleukin-12 may stimulate a person's white blood cells to kill melanoma cells. Combining vaccine therapy and interleukin-12 with interleukin-2 may be a more effective treatment for metastatic melanoma. PURPOSE: This randomized phase II trial is studying vaccine therapy, interleukin-12, and interleukin-2 to see how well they work compared to vaccine therapy and interleukin-12 in treating patients with metastatic melanoma.


Study summary:

OBJECTIVES: - Compare peptide-interferon-gamma production by CD8+ T cells in patients with metastatic melanoma immunized with MAGE-3, Melan-A, gp100 antigen, and NA17-A peptide-pulsed autologous peripheral blood mononuclear cells and interleukin-12 with or without low-dose interleukin-2. - Compare the clinical response rate (complete and partial response) in patients treated with these regimens. OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive immunization comprising MAGE-3, Melan-A, gp100 antigen, and NA17-A peptide-pulsed autologous peripheral blood mononuclear cells subcutaneously (SC) on day 1 and interleukin-12 (IL-12) SC on days 1, 3, and 5. - Arm II: Patients receive immunization and IL-12 as in arm I and low-dose interleukin-2 SC on days 7-18. Treatment in both arms repeats every 21 days for a total of 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving an objective response or stable disease may receive additional treatment sets of 3 courses for up to a total of 9 courses. Patients are followed every 8 weeks until disease progression and then at least every 3 months thereafter. PROJECTED ACCRUAL: A total of 36 patients (18 per treatment arm) will be accrued for this study within 1.25 years.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed melanoma - Evidence of metastatic disease by radiological or physical examination - In-transit metastases allowed - HLA-A2 positive - No untreated brain metastases - Brain lesions successfully treated by stereotactic radiotherapy or surgery with no recurrence at 28-day follow-up are allowed PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 70-100% Life expectancy - At least 12 weeks Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Hemoglobin at least 9 g/dL - Platelet count at least 100,000/mm^3 Hepatic - SGPT no greater than 2 times upper limit of normal (ULN) - Bilirubin no greater than 1.5 times ULN - Lactic dehydrogenase less than 1.25 times ULN - Hepatitis B and C negative Renal - Creatinine no greater than 1.5 times ULN - Calcium no greater than 11 mg/dL Cardiovascular - No significant cardiovascular disease - No cardiac arrhythmia requiring medical intervention Immunologic - HIV negative - No intrinsic immunosuppression - No serious concurrent infection, including active tuberculosis - No prior or active autoimmune disease including: - Rheumatoid arthritis (rheumatoid factor-positive with current or recent flare) - Inflammatory bowel disease - Systemic lupus erythematosus - Clinical evidence and antibody titer at least 1:80 - Ankylosing spondylitis - Scleroderma - Multiple sclerosis - Autoimmune hemolytic anemia - Immune thrombocytopenic purpura Other - Not pregnant or nursing - Negative pregnancy test - No psychiatric illness that would preclude study compliance or giving informed consent - No active gastrointestinal bleeding - No uncontrolled peptic ulcer disease PRIOR CONCURRENT THERAPY: Biologic therapy - More than 4 weeks since prior biologic therapy - No prior melanoma vaccine therapy containing the same MAGE-3, Melan-A, gp100 antigen, or NA17 peptides used in the study Chemotherapy - Prior chemotherapy allowed Endocrine therapy - No concurrent systemic corticosteroids except physiologic replacement doses Radiotherapy - See Disease Characteristics Surgery - See Disease Characteristics Other - No concurrent immunosuppressive drugs (e.g., cyclosporine)


NCT ID:

NCT00064168


Primary Contact:

Study Chair
Thomas F. Gajewski, MD, PhD
University of Chicago


Backup Contact:

N/A


Location Contact:

Chicago, Illinois 60637
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 12, 2017

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