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Vaccine Therapy in Treating Patients With Stage IV or Relapsed Malignant Melanoma Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Vaccine Therapy in Treating Patients With Stage IV or Relapsed Malignant Melanoma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Vaccine Therapy in Treating Patients With Stage IV or Relapsed Malignant Melanoma Clinical research trials and Vaccine Therapy in Treating Patients With Stage IV or Relapsed Malignant Melanoma health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Vaccine Therapy in Treating Patients With Stage IV or Relapsed Malignant Melanoma. Vaccine Therapy in Treating Patients With Stage IV or Relapsed Malignant Melanoma Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Vaccine Therapy in Treating Patients With Stage IV or Relapsed Malignant Melanoma clinical trial. Test subjects typically receive the most expert healthcare available for their Vaccine Therapy in Treating Patients With Stage IV or Relapsed Malignant Melanoma condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "V" Clinical Trials Conditions > Vaccine Therapy in Treating Patients With Stage IV or Relapsed Malignant Melanoma  Vaccine Therapy in Treating Patients With Stage IV or Relapsed Malignant Melanoma
Vaccine Therapy in Treating Patients With Stage IV or Relapsed Malignant Melanoma
For Condition: Recurrent Melanoma,Stage 4 Melanoma
Status: No longer recruiting
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have stage IV, or relapsed malignant melanoma.
Details: OBJECTIVES: - Determine the safety of administering MART-1 peptide-pulsed dendritic cells to patients with stage IV or relapsed malignant melanoma. - Determine the immunological and clinical responses in this patient population after this therapy. OUTLINE: This is a dose-escalation study. Patients undergo leukapheresis between days -14 to -8. Mononuclear cells are isolated, used to generate dendritic cells (DC), and then pulsed with MART-1 peptide. Patients are vaccinated with MART-1 peptide-pulsed DC either IV or intradermally on days 0, 14, and 28. Cohorts of 3-6 patients receive escalating doses of MART-1 peptide-pulsed DC until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients are followed until death. PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed malignant melanoma - Stage IV or relapsed - HLA-A2.1-positive and MART-1 expression determined by reverse transcriptase-polymerase chain reaction or immunohistochemistry - No uncontrolled CNS metastasis - CNS metastases treated with CNS irradiation to control local tumor growth allowed PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 70-100% Life expectancy: - Not specified Hematopoietic: - Hemoglobin greater than 9.0 g/dL (transfusion independent) - Platelet count greater than 100,000/mm3 - WBC greater than 3,000/mm3 - Absolute neutrophil count greater than 1,000/mm3 Hepatic: - Not specified Renal: - Not specified Cardiovascular: - No prior evidence of New York Heart Association class III or IV heart disease Pulmonary: - No acute lung disease that would preclude anesthesia or surgery - No dyspnea at rest Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No prior evidence of opportunistic infection - No acute viral, bacterial, or fungal infection requiring specific therapy within the past 14 days - No acute medical problems that may be considered an unacceptable anesthetic or operative risk - No underlying condition that would preclude study therapy - No allergies to study reagents - No organ allografts - Positive skin test to common antigens (i.e., tetanus and Candida) - HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 30 days since prior immunotherapy Chemotherapy: - At least 30 days since prior chemotherapy - No concurrent chemotherapy Endocrine therapy: - No concurrent corticosteroids Radiotherapy: - At least 30 days since prior radiotherapy Surgery: - At least 30 days since prior surgery Other: - No concurrent cyclosporine
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JamesEconomou, Study Chair, Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Additional Information:
Study ID Numbers: CDR0000067754; NCI-H00-0050,UCLA-9508375
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005617
Other Recurrent Melanoma Studies:
1. Vaccine Therapy in Treating Patients With Stage IV or Recurrent Melanoma
2. Vaccine Therapy With or Without Biological Therapy in Treating Patients With Metastatic Melanoma
3. Interleukin-12 and Interferon alfa in Treating Patients With Metastatic Malignant Melanoma
4. Dacarbazine With or Without Oblimersen (G3139) in Treating Patients With Advanced Malignant Melanoma
5. Biological Therapy in Treating Patients With Metastatic Melanoma
Related Studies:
Other Recurrent Melanoma Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Vaccine Therapy in Treating Patients With Stage IV or Relapsed Malignant Melanoma
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