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Vaccine Therapy and Interleukin-12 in Treating Patients With Metastatic Melanoma



Vaccine Therapy and Interleukin-12 in Treating Patients With Metastatic Melanoma

For Condition: childhood skin cancer,Stage 4 Melanoma,Recurrent Melanoma
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , University of Chicago Cancer Research Center
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed metastatic melanoma - Patient must express HLA-A2 (a human leukocyte antigen) - Tumor must express MAGE-3 or Melan-A by polymerase chain reaction (PCR) analysis - No untreated brain metastases --Prior/Concurrent Therapy-- - Biologic therapy: No concurrent immunosuppressive drugs; At least 4 weeks since biologic therapy - Chemotherapy: At least 2 weeks since chemotherapy - Endocrine therapy: No concurrent systemic corticosteroids (except physiologic replacement doses) - Radiotherapy: At least 2 weeks since radiotherapy - Surgery: At least 2 weeks since surgery --Patient Characteristics-- - Age: Not specified - Performance status: Karnofsky 70%-100% - Life expectancy: At least 12 weeks - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 9 g/dL - Hepatic: Bilirubin no greater 1.5 times upper limit of normal (ULN); SGPT no greater than 2 times ULN - Renal: Calcium no greater than 11 mg/dL; Creatinine no greater than 1.5 times ULN - Cardiovascular: No significant cardiovascular disease or cardiac arrhythmia requiring medical intervention - Other: Hepatitis B surface antigen negative; HIV negative; No serious concurrent infection; No clinically significant autoimmune disease; No active gastrointestinal bleeding or uncontrolled peptic ulcer disease; No history of inflammatory bowel disease; No psychiatric illness that may interfere with compliance in study Not pregnant or nursing
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
ThomasGajewski,  Study Chair,  University of Chicago Cancer Research Center

University of Chicago Cancer Research Center
Chicago,  Illinois,  60637
United States
 


Additional Information:
Study ID Numbers:  CDR0000065424;  UCCRC-9018,NCI-G97-1162,UCCRC-8381
Study Start Date: January 1997
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002952

Other Recurrent Melanoma Studies:
1. CC-5013 in Treating Patients With Progressive or Relapsed Metastatic Melanoma

2. Interleukin-12 and Interferon alfa in Treating Patients With Metastatic Kidney Cancer or Malignant Melanoma

3. Monoclonal Antibody and Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Has Been Removed During Surgery

4. Chemotherapy Followed by Biological Therapy in Treating Patients With Stage IV Melanoma That Cannot be Treated With Surgery

5. Boron Neutron Capture Therapy in Treating Patients With Melanoma

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