Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Chicago, Illinois 60637


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.


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)



Primary Contact:

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

Backup Contact:


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: March 16, 2018

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.