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Vaccine Therapy in Treating Patients Who Have Stage II, Stage III, or Stage IV Melanoma Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Vaccine Therapy in Treating Patients Who Have Stage II, 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 in Treating Patients Who Have Stage II, Stage III, or Stage IV Melanoma Clinical research trials and Vaccine Therapy in Treating Patients Who Have Stage II, Stage III, or Stage IV Melanoma healthcare trials happen in hundreds of localities throughout 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 usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Vaccine Therapy in Treating Patients Who Have Stage II, Stage III, or Stage IV Melanoma. Vaccine Therapy in Treating Patients Who Have Stage II, Stage III, or Stage IV Melanoma Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Vaccine Therapy in Treating Patients Who Have Stage II, Stage III, or Stage IV Melanoma clinical trial. Subjects frequently obtain the most expert healthcare possible for their Vaccine Therapy in Treating Patients Who Have Stage II, Stage III, or Stage IV Melanoma condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "V" Clinical Trials Conditions > Vaccine Therapy in Treating Patients Who Have Stage II, Stage III, or Stage IV Melanoma  Vaccine Therapy in Treating Patients Who Have Stage II, Stage III, or Stage IV Melanoma
Vaccine Therapy in Treating Patients Who Have Stage II, Stage III, or Stage IV Melanoma
For Condition: Stage 4 Melanoma,stage 2 melanoma,stage 3 melanoma
Status: No longer recruiting
Sponsor(s): Genzyme ,
Synopsis: RATIONALE: Vaccines 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 II, stage III, or stage IV melanoma.
Details: OBJECTIVES: I. Determine the safety and the maximum tolerated dose of vaccines containing two adenoviral vectors encoding the melanoma antigens Melan-A/MART-1 and gp100 in patients with stage II-IV melanoma. II. Assess the dose-response changes in the frequency of MART-1 and gp100 reactive T cells (CD4+ and CD8+) in patients receiving one of three different vaccine regimens. III. Assess the T-cell response to one melanoma antigen following three treatments with the other antigen in these patients. IV. Assess the effect of concomitant vaccination with both antigens on T-cell response in these patients. PROTOCOL OUTLINE: This is a dose escalation study. Patients are sequentially enrolled on 1 of 3 treatment arms. Each treatment arm has 3 groups. Arm I: Patients receive Ad2/MART-1v2 vaccine and Ad2/gp100v2 vaccine intradermally (ID) at the lowest dose level once every three weeks for either 6 or 15 weeks depending on assignment. Arm II: Patients receive Ad2/gp100v2 vaccine and Ad2/MART-1v2 vaccine ID at the mid-range dose level once every three weeks for either 6 or 15 weeks depending on assignment. Arm III: Patients receive Ad2/MART-1v2 vaccine and Ad2/gp100v2 vaccine ID at the highest dose level once every three weeks for either 6 or 15 weeks depending on assignment. Cohorts of 3-6 patients receive escalating doses of Ad2/MART-1v2 and/or Ad2/gp100v2 vaccines in each arm until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 3 months, 6 months, and 1 year after completion of treatment. PROJECTED ACCRUAL: A total of 24-36 patients will be accrued over 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed stage II, III, or IV cutaneous malignant melanoma - No evidence of disease at time of entry to protocol - Definitive complete surgical resection within past 12 months - HLA-A2 positive --Prior/Concurrent Therapy-- - Biologic therapy: No prior or concurrent immunotherapy; At least 3 months since prior interferon therapy - Chemotherapy: No prior or concurrent chemotherapy - Endocrine therapy: No prior or concurrent immunosuppressants - Radiotherapy: At least 4 weeks since prior radiotherapy - Surgery: At least 4 weeks since prior surgery - Other: No other prior or concurrent experimental anticancer therapy --Patient Characteristics-- - Age: 18 or over - Performance status: ECOG 0-1 - Life expectancy: Not specified - Hematopoietic: WBC at least 3,000 cells/mm3; Platelet count at least 100,000 cells/mm3; No clinically significant hematologic disease that would preclude study - Hepatic: SGOT and SGPT less than 2 times upper limit of normal; Bilirubin less than 2 mg/dL; No clinically significant hepatic disease that would preclude study - Renal: Creatinine less than 2 mg/dL; No clinically significant renal disease that would preclude study - Cardiovascular: No clinically significant cardiac disease that would preclude study - Other: No clinically significant underlying condition that would preclude study; No significant autoimmune disease or other major immune system disorder; HIV negative; HTLV negative; Hepatitis B and C negative; No active infection requiring parenteral antibiotics; No psychiatric disorder that could hinder protocol compliance; Not pregnant or nursing; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AmyBock, Study Chair, Genzyme
Genzyme Corporation
Cambridge, Massachusetts, 02139-1562
United States
U.S. Oncology
Houston, Texas, 77060
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Additional Information:
Study ID Numbers: CDR0000068478; GENZ-2000-P-000380/1,GENZ-ADVMEL-001-99,DFCI-00069
Study Start Date: November 2000
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00010309
Other Stage 2 Melanoma Studies:
1. Diagnostic Study to Predict the Risk of Developing Metastatic Cancer in Patients With Stage I or Stage II Melanoma
2. Interferon alfa-2b in Treating Patients With Melanoma and Early Lymph Node Metastasis
3. Vaccine Therapy in Treating Patients With Stage II Melanoma That Can Be Removed by Surgery
4. Vaccine Therapy in Treating Patients With Melanoma
5. Vaccine Therapy in Treating Patients Who Have Stage II, Stage III, or Stage IV Melanoma
Related Studies:
Other stage 2 melanoma Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Vaccine Therapy in Treating Patients Who Have Stage II, Stage III, or Stage IV Melanoma
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