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Vaccine Therapy in Treating Patients With Stage IV Melanoma Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Vaccine Therapy in Treating Patients With Stage IV 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 Melanoma Clinical research trials and Vaccine Therapy in Treating Patients With Stage IV Melanoma health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Vaccine Therapy in Treating Patients With Stage IV Melanoma. Vaccine Therapy in Treating Patients With Stage IV Melanoma Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Vaccine Therapy in Treating Patients With Stage IV Melanoma clinical trial. Human subjects often get the best healthcare available for their Vaccine Therapy in Treating Patients With Stage IV Melanoma condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "V" Clinical Trials Conditions > Vaccine Therapy in Treating Patients With Stage IV Melanoma  Vaccine Therapy in Treating Patients With Stage IV Melanoma
Vaccine Therapy in Treating Patients With Stage IV Melanoma
For Condition: Stage 4 Melanoma,Recurrent Melanoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , University of Pennsylvania Cancer Center
Synopsis: RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: Randomized phase I trial to study the effectiveness of vaccine therapy in treating patients who have stage IV melanoma.
Details: OBJECTIVES: I. Determine the dose-limiting toxicities, maximum tolerated dose, recommended phase II dose, and rate of sensitization of T cells at each dose level in patients with melanoma receiving dendritic cell vaccine. II. Determine the overall (complete and partial) response rate, duration of response, and optimal route of administration in this patient population. PROTOCOL OUTLINE: This is a dose escalation study. Patients are randomized to one of three treatment arms. All patients undergo leukopheresis to obtain lymphocyte and myeloid origin mononuclear cell fractions for preparation of dendritic cell (DC) vaccine. In each arm, cohorts of up to 5 patients receive escalating doses of vaccine. The maximum tolerated dose (MTD) is defined as the dose preceding that at which 2 or more of 5 patients experience dose-limiting toxicity. Randomization ceases if the MTD has been reached in 2 arms, although accrual may continue. Treatment repeats every 2 weeks for a total of 4 doses. Arm I: Patients receive 3 different doses of peptide pulsed DC vaccine IV, each divided into 3 different peptide pulsed pools administered over 30 minutes. Arm II: Patients receive 3 different doses of peptide pulsed DC vaccine subcutaneously/intradermally to sites with no evidence of disease. At the lowest dose, patients receive 3 different peptide pulsed pools, each administered at a separate site. At the higher doses, patients receive 3 injections further subdivided into 6 and administered at 6 distinct sites. Arm III: Patients receive peptide pulsed DC vaccine intranodally in groin or ancillary lymph nodes at the lower 2 doses of the 3 administered to arms I and II. At the lower dose, patients receive 3 different peptide pulsed pools, each administered into a different node. At the higher dose, patients receive 3 injections further subdivided into 6 and administered at 6 distinct sites. Patients are followed at 2 weeks and then monthly for 3 months. PROJECTED ACCRUAL: A maximum of 40 patients will be accrued for this study within 14 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed stage IV melanoma - Must be MHC Class I HLA-A2.1 --Prior/Concurrent Therapy-- - Biologic therapy: At least 30 days since prior immunotherapy; No concurrent immunotherapy - Chemotherapy: At least 30 days since prior chemotherapy; No concurrent chemotherapy - Endocrine therapy: Not specified - Radiotherapy: At least 30 days since prior radiotherapy; No concurrent radiotherapy - Surgery: Not specified --Patient Characteristics-- - Age: Over 18 - Performance status: ECOG 0-1 - Life expectancy: At least 2 months - Hematopoietic: Platelet count at least 100,000/mm3; INR no greater than 1.5 mg/dL; No coagulopathies including thrombocytopenia - Hepatic: Partial thromboplastin time no greater than 50 seconds - Renal: Not specified - Cardiovascular: No major cardiac illness - Pulmonary: No major respiratory illness - Other: No active systemic infection or other illness; No peripheral vascular disease; Not pregnant or nursing; Effective contraception required of all fertile patients during and for one month after completion of treatment
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BrianCzerniecki, Study Chair, University of Pennsylvania Cancer Center
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
United States
Additional Information:
Study ID Numbers: CDR0000066759; UPCC-4697,NCI-T98-0033
Study Start Date: April 1999
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003665
Other Stage 4 Melanoma Studies:
1. Bevacizumab With or Without Interferon alfa in Treating Patients With Metastatic Malignant Melanoma
2. Biological Therapy in Treating Patients With Metastatic Melanoma
3. Vaccine Therapy With or Without Sargramostim in Treating Patients With High-Risk or Metastatic Melanoma
4. Interferon alfa-2b With or Without Radiation Therapy in Treating Patients With Melanoma That Has Metastasized to Lymph Nodes in the Neck, Under the Arm, or in the Groin
5. Vaccine Therapy in Treating Patients With Metastatic Melanoma
Related Studies:
Other Stage 4 Melanoma Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Vaccine Therapy in Treating Patients With Stage IV Melanoma
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