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Vaccine Therapy in Treating Patients With Stage IV or Recurrent Malignant Melanoma Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Vaccine Therapy in Treating Patients With Stage IV or Recurrent Malignant Melanoma conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Vaccine Therapy in Treating Patients With Stage IV or Recurrent Malignant Melanoma Clinical research trials and Vaccine Therapy in Treating Patients With Stage IV or Recurrent Malignant Melanoma healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Vaccine Therapy in Treating Patients With Stage IV or Recurrent Malignant Melanoma. Vaccine Therapy in Treating Patients With Stage IV or Recurrent Malignant Melanoma Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Vaccine Therapy in Treating Patients With Stage IV or Recurrent Malignant Melanoma clinical trial. Participants typically obtain the most effective healthcare available for their Vaccine Therapy in Treating Patients With Stage IV or Recurrent Malignant Melanoma condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. 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 Recurrent Malignant Melanoma  Vaccine Therapy in Treating Patients With Stage IV or Recurrent Malignant Melanoma
Vaccine Therapy in Treating Patients With Stage IV or Recurrent Malignant Melanoma
For Condition: Stage 4 Melanoma,Recurrent Melanoma
Status: Recruiting
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Vaccines made by inserting a laboratory-treated gene into a person's white blood cells 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 recurrentmalignantmelanoma.
Details: OBJECTIVES: - Determine the safety of vaccination with MART-1 adenovirus-transduced dendritic cells in patients with stage IV or recurrent malignant melanoma. - Determine the immunological and clinical responses of patients receiving this vaccine. OUTLINE: This is a dose-escalation study. Patients undergo leukapheresis. Mononuclear cells are isolated and dendritic cells (DC) are generated. DC are incubated with the adenoviral vector containing MART-1. Patients receive MART-1 adenovirus-transduced dendritic cell (AdVMART1/DC) vaccine intradermally on days 0, 14, and 28. Patients with a significant clinical or immunological response are eligible for 6 additional monthly vaccinations. Cohorts of 3-6 patients receive escalating doses of the AdVMART1/DC vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed on weeks 1, 4, and 12 and then for survival. PROJECTED ACCRUAL: A total of 6-36 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 stage IV or recurrent malignant melanoma - HLA-A2.1 and/or HLA-DR4 positive and MART-1 expression determined by reverse transcription polymerase chain reaction or immunohistochemistry - No uncontrolled CNS metastases - CNS metastases allowed if treated with CNS irradiation to control local tumor growth PATIENT CHARACTERISTICS: Age: - Over 18 Performance status: - Karnofsky 70-100% Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count greater than 1,000/mm^3 - WBC greater than 3,000/mm^3 - Hemoglobin greater than 9.0 g/dL - Platelet count greater than 100,000/mm^3 Hepatic: - Not specified Renal: - Not specified Cardiovascular: - No prior evidence of New York Heart Association class III-IV cardiac insufficiency - No coronary artery disease - No acute ischemic heart disease that would preclude anesthesia or surgery Pulmonary: - No acute lung disease that would preclude anesthesia or surgery Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Positive skin test to common antigens (e.g., tetanus and/or Candida) - HIV negative - No prior evidence of opportunistic infection - No prior clinical evidence of autoimmune disease - No other underlying condition that would preclude study participation - No allergies to study reagents - No other acute medical problem that would preclude anesthesia or surgery PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 30 days since prior immunotherapy for melanoma Chemotherapy: - At least 30 days since prior chemotherapy for melanoma - No concurrent chemotherapy Endocrine therapy: - No concurrent corticosteroids Radiotherapy: - See Disease Characteristics - At least 30 days since prior radiotherapy for melanoma Surgery: - More than 30 days since prior surgery for melanoma - No prior organ allograft Other: - At least 14 days since prior therapy for any acute viral, bacterial, or fungal infection - No concurrent specific therapy for any acute viral, bacterial, or fungal infection - No concurrent cyclosporine
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JamesEconomou, Study Chair, Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-1781
United States
Recruiting James Economou 310-794-6913
Additional Information:
Study ID Numbers: CDR0000069373; UCLA-9707074,NCI-G02-2077
Study Start Date:
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00039325
Other Recurrent Melanoma Studies:
1. Vaccine Therapy in Treating Patients With Unresectable Metastatic Melanoma
2. Gene Therapy in Treating Patients With Stage III or Stage IV Melanoma
3. Vaccine Therapy in Treating Patients With Stage IV or Recurrent Melanoma
4. Vaccine Therapy in Treating Patients With Metastatic Melanoma
5. Radiation Therapy Followed by Stereotactic Radiosurgery in Treating Patients With Brain Metastases From Malignant 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 Recurrent Malignant Melanoma
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