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Vaccine Therapy in Treating Patients With Stage II or Stage III Melanoma That Has Been Surgically Removed Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Vaccine Therapy in Treating Patients With Stage II or Stage III Melanoma That Has Been Surgically Removed conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Vaccine Therapy in Treating Patients With Stage II or Stage III Melanoma That Has Been Surgically Removed Clinical research trials and Vaccine Therapy in Treating Patients With Stage II or Stage III Melanoma That Has Been Surgically Removed healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Vaccine Therapy in Treating Patients With Stage II or Stage III Melanoma That Has Been Surgically Removed. Vaccine Therapy in Treating Patients With Stage II or Stage III Melanoma That Has Been Surgically Removed Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Vaccine Therapy in Treating Patients With Stage II or Stage III Melanoma That Has Been Surgically Removed clinical trial. Human subjects often receive the most effective healthcare possible for their Vaccine Therapy in Treating Patients With Stage II or Stage III Melanoma That Has Been Surgically Removed condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "V" Clinical Trials Conditions > Vaccine Therapy in Treating Patients With Stage II or Stage III Melanoma That Has Been Surgically Removed  Vaccine Therapy in Treating Patients With Stage II or Stage III Melanoma That Has Been Surgically Removed
Vaccine Therapy in Treating Patients With Stage II or Stage III Melanoma That Has Been Surgically Removed
For Condition: stage 3 melanoma,stage 2 melanoma
Status: Suspended
Sponsor(s): National Cancer Institute (NCI) , Rockefeller University
Synopsis: RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune response to kill tumor cells. PURPOSE: Randomized phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have stage II or stage III melanoma that has been surgically removed.
Details: OBJECTIVES: I. Compare the immunogenicity of vaccination with melanoma antigen-pulsed dendritic cells vs melanoma antigens with QS21 adjuvant in patients with surgically resected stage IIB, IIC, or III melanoma. II. Compare the toxicity of these vaccinations in these patients. PROTOCOL OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients undergo leukapheresis to obtain peripheral blood mononuclear cells (PBMC). PBMC are cultured with sargramostim (GM-CSF) and interleukin-4 to generate dendritic cells (DC). DC are then pulsed with endotoxin-free keyhole limpet hemocyanin (KLH), flu matrix, and HLA A*0201-restricted melanoma antigens (Melan-A, MART-1, gp100 antigen, tyrosinase, MAGE-3, and NY-ESO-B) to elicit antigen-specific CD8+ T cells. One day after the DC are exposed to the antigens, patients receive a priming injection of melanoma antigen-pulsed DC vaccine subcutaneously (SC) on day 1 of week 1. Arm II: Patients receive a priming injection of vaccine comprising KLH, flu matrix, and HLA A*0201-restricted melanoma antigens with QS21 adjuvant SC on day 1 of week 1. In both arms, patients then receive 3 booster injections of vaccine (that dose not contain KLH) SC monthly (weeks 4, 8, and 12) for a total of 4 injections. Patients are followed every 12 weeks. PROJECTED ACCRUAL: A total of 50 patients (25 per treatment arm) will be accrued for this study within 1.5-3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of stage IIB, IIC, or III melanoma that has been surgically resected - Patient refused interferon alfa - More than 6 months since definitive surgical resection HLA-A0201 positive --Prior/Concurrent Therapy-- Biologic therapy: No prior peptides used in this study, melanoma protein vaccine, melanoma whole cell vaccines, or QS21 Chemotherapy: - No prior chemotherapy - No concurrent sytemic therapy Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy Surgery: - See Disease Characteristics - Recovered from prior surgery - No concurrent surgery --Patient Characteristics-- Age: 18 and over Performance status: Karnofsky 80-100% Life expectancy: Not specified Hematopoietic: - WBC at least 3,500/mm3 - Platelet count at least 125,000/mm3 - Hemoglobin at least 9 g/dL Hepatic: - Lactic dehydrogenase no greater than 2 times normal - Bilirubin no greater than 2 mg/dL - Albumin at least 3.5 mg/dL - No chronic active hepatitis Renal: Creatinine no greater than 2 mg/dL Other: - HIV negative - No pre-existing retinal or choroidal eye disease - No allergy to shellfish - No allergy to gentamicin, tobramycin, streptomycin, or amikacin - No known autoimmune disease (e.g., systemic lupus erythematosus or rheumatoid arthritis) except vitiligo - No chronic infection - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
NinaBhardwaj, Study Chair, Rockefeller University
Rockefeller University Hospital
New York City, New York, 10021-6399
United States
Additional Information:
Study ID Numbers: CDR0000256890; NCI-5636,RUH-NBH-0428-0401
Study Start Date: April 2002
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00045383
Other Stage 2 Melanoma Studies:
1. Vaccine Therapy in Treating Patients With Stage II or Stage III Melanoma That Has Been Surgically Removed
2. Vaccine Therapy in Treating Patients With Primary Stage II Melanoma
3. Vaccine Therapy in Treating Patients Who Have Stage II, Stage III, or Stage IV Melanoma
4. High-Dose Interferon alfa in Treating Patients With Stage II or Stage III Melanoma
5. Interferon alfa-2b in Treating Patients With Melanoma and Early Lymph Node Metastasis
Related Studies:
Other stage 2 melanoma Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Vaccine Therapy in Treating Patients With Stage II or Stage III Melanoma That Has Been Surgically Removed
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