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Vaccine Therapy Followed by Biological Therapy in Treating Patients With Stage III or Stage IV Melanoma Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Vaccine Therapy Followed by Biological Therapy in Treating Patients With Stage III or Stage IV Melanoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Vaccine Therapy Followed by Biological Therapy in Treating Patients With Stage III or Stage IV Melanoma Clinical research trials and Vaccine Therapy Followed by Biological Therapy in Treating Patients With Stage III or Stage IV Melanoma healthcare trials happen in many of places across 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 effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Vaccine Therapy Followed by Biological Therapy in Treating Patients With Stage III or Stage IV Melanoma. Vaccine Therapy Followed by Biological Therapy in Treating Patients With Stage III or Stage IV Melanoma Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Vaccine Therapy Followed by Biological Therapy in Treating Patients With Stage III or Stage IV Melanoma clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Vaccine Therapy Followed by Biological Therapy in Treating Patients With Stage III or Stage IV Melanoma condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "V" Clinical Trials Conditions > Vaccine Therapy Followed by Biological Therapy in Treating Patients With Stage III or Stage IV Melanoma  Vaccine Therapy Followed by Biological Therapy in Treating Patients With Stage III or Stage IV Melanoma
Vaccine Therapy Followed by Biological Therapy in Treating Patients With Stage III or Stage IV Melanoma
For Condition: Stage 4 Melanoma,Recurrent Melanoma,stage 3 melanoma
Status: No longer recruiting
Sponsor(s): University of Southern California , National Cancer Institute (NCI)
Synopsis: RATIONALE: Vaccines made from melanoma cells may make the body build an immune response to kill tumor cells. Biological therapies such as interferon gamma and interleukin-2 use different ways to stimulate the immune system and stop cancer cells from growing. Combining vaccine therapy with biological therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of vaccine therapy, interferon gamma, and interleukin-2 in treating patients who have stage III or stage IV melanoma.
Details: OBJECTIVES: - Determine the clinical response rate and immune response in HLA-A2 positive patients with stage III or IV melanoma after receiving autologous dendritic cells pulsed with melanoma antigen peptides (MART-1:26-35, gp100:209-217, and tyrosinase:368-376) and treated ex vivo with CD40-ligand and interferon gamma, followed by interleukin-2 in vivo. - Determine the toxicities of this regimen in these patients. OUTLINE: This is a multicenter study. Patients undergo leukapheresis to harvest autologous dendritic cells (ADCs). Melanoma peptides (MART-1:26-35, gp100:209-217, and tyrosinase:368-376) are pulsed separately onto ADCs, which are also treated ex vivo with CD40-ligand, interferon gamma, interleukin-4, sargramostim (GM-CSF), and Candida albicans skin test reagent. Patients receive each melanoma peptide pulsed ADC vaccine separately via 3 successive 10 minute infusions on day 1. Patients then receive interleukin-2 subcutaneously every 12 hours on days 2-6. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 4 weeks, then every 3 months for 2 years, then every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study within 18-24 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed metastatic melanoma - Measurable disease after attempted curative surgery - Unresectable stage III or IV uveal melanoma - Metastatic mucosal melanoma - HLA-A2.1 positive - No disease progression following high dose interleukin-2 (600,000 or 720,000 IU/kg every 8 hours) PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - WBC at least 3,000/mm^3 - Platelet count at least 75,000/mm^3 - Hemoglobin at least 9.0 g/dL - No coagulation disorders Hepatic: - Bilirubin no greater than 2.0 mg/dL Renal: - Creatinine no greater than 2.0 mg/dL Cardiovascular: - No myocardial infarction within the past 6 months - Patients with documented or suspected coronary artery disease must undergo stress thallium test - No major cardiovascular illness Pulmonary: - No major pulmonary illness Immunologic: - HIV negative - Hepatitis B surface antigen negative - Hepatitis C antibody negative - No history of uveitis or autoimmune inflammatory eye disease Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No major systemic infection - No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or basal cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - No prior MART-1:26-35, gp100:209-217, or tyrosinase:368-376 antigens Chemotherapy: - At least 1 month since prior chemotherapy for melanoma Endocrine therapy: - No concurrent steroid therapy Radiotherapy: - At least 1 month since prior radiotherapy for melanoma Surgery: - See Disease Characteristics Other: - At least 1 month since prior adjuvant therapy for melanoma - At least 1 month since other prior therapy for melanoma
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JeffreyWeber, Study Chair, University of Southern California
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90089
United States
Additional Information:
Study ID Numbers: CDR0000068125; LAC-USC-10M991,NCI-G00-1837,NCI-T99-0102
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006113
Other Stage 4 Melanoma Studies:
1. Flavopiridol Plus Cisplatin or Carboplatin in Treating Patients With Advanced Solid Tumors
2. PET and CT Scans to Evaluate Patients With Stage III or Stage IV Melanoma
3. Chemotherapy Followed by Biological Therapy in Treating Patients With Stage IV Melanoma That Cannot be Treated With Surgery
4. Bevacizumab With or Without Interferon alfa in Treating Patients With Metastatic Malignant Melanoma
5. Carboplatin and Temozolomide in Treating Patients With Unresectable or Metastatic Melanoma
Related Studies:
Other Stage 4 Melanoma Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Vaccine Therapy Followed by Biological Therapy in Treating Patients With Stage III or Stage IV Melanoma
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