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Gene Therapy in Treating Patients With 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 Gene 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. Gene Therapy in Treating Patients With Stage III or Stage IV Melanoma Clinical research trials and Gene Therapy in Treating Patients With 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 Gene Therapy in Treating Patients With Stage III or Stage IV Melanoma. Gene Therapy in Treating Patients With 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 Gene Therapy in Treating Patients With Stage III or Stage IV Melanoma clinical trial. Subjects frequently obtain the most expert healthcare possible for their Gene Therapy in Treating Patients With 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 > "G" Clinical Trials Conditions > Gene Therapy in Treating Patients With Stage III or Stage IV Melanoma  Gene Therapy in Treating Patients With Stage III or Stage IV Melanoma
Gene Therapy in Treating Patients With Stage III or Stage IV Melanoma
For Condition: stage 3 melanoma,Stage 4 Melanoma,Recurrent Melanoma
Status: No longer recruiting
Sponsor(s): Vical ,
Synopsis: RATIONALE: Injecting allovectin-7 into a person's melanoma cells may make the body build an immune response that will kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of gene therapy in treating patients who have stage III or stage IV melanoma that has not responded to previous treatment.
Details: OBJECTIVES: I. Demonstrate an objective clinical response (partial or complete) with a median duration of at least 4 months in 15% of patients with stage III or IV melanoma treated with Allovectin-7. Allovectin-7 is a direct gene transfer immunotherapeutic agent. II. Determine the benefits, risks, and side effects of Allovectin-7 in this patient population. PROTOCOL OUTLINE: This is a multicenter study. Patients receive an intratumoral injection of Allovectin-7 once weekly for 6 weeks. At week 9, a complete disease status assessment is performed. Patients with stable or responding disease may receive additional courses of 6 injections. PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed melanoma; Stage III with locoregional disease, in transit metastasis, or nodal disease OR Stage IV metastatic disease in skin, subcutaneous tissue, lymph node(s), and/or lung - At least 1 metastasis for which surgery is not deemed to be a curative option - Relapsed from or has not responded to frontline chemotherapy or biotherapy - At least 1 measurable tumor at least 1 cm by 1 cm, but less than 5 cm by 5 cm - No history of brain metastases or visceral metastases other than lung metastases --Prior/Concurrent Therapy-- - Biologic therapy: See Disease Characteristics; At least 4 weeks since prior biologic therapy - Chemotherapy: See Disease Characteristics; At least 4 weeks since prior chemotherapy - Endocrine therapy: No concurrent immunosuppressive drugs - Radiotherapy: At least 4 weeks since prior radiotherapy - Surgery: At least 2 weeks since prior major surgery - Other: No other concurrent anticancer drug therapy, or any other experimental therapy --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 80-100% - Life expectancy: At least 6 months - Hematopoietic: WBC at least 3,000/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 9 g/dL - Hepatic: Bilirubin no greater than 2.0 mg/dL; SGOT/SGPT less than 3 times upper limit of normal; PT/PTT normal LDH and albumin normal - Renal: Creatinine no greater than 2.0 mg/dL - Cardiovascular: No uncontrolled hypertension; No New York Heart Association class III or IV disease - Other: HIV negative; Negative pregnancy test; Fertile patients must use effective contraception; No active autoimmune disease; No active infection requiring parenteral antibiotics; No uncontrolled diabetes mellitus; No other prior malignancy in the past 5 years except skin cancer or stage 0-II cervical cancer; No significant psychiatric disorders
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JenniferFernandez, Study Chair, Vical
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Physician Reliance Network, Inc.
Dallas, Texas, 75246
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Additional Information:
Study ID Numbers: CDR0000066735; VCL-1005-205
Study Start Date: October 1998
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003646
Other Stage 4 Melanoma Studies:
1. Vaccine Therapy in Treating Patients With Stage IV Melanoma
2. Carboplatin and Temozolomide in Treating Patients With Unresectable or Metastatic Melanoma
3. Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma
4. Chemotherapy Plus Bone Marrow Transplantation in Treating Patients With Metastatic Melanoma
5. CCI-779 in Treating Patients With Metastatic Melanoma
Related Studies:
Other Stage 4 Melanoma Clinical Trials
Other Minnesota Clinical Trials
Other Rochester Clinical Trials
Gene Therapy in Treating Patients With Stage III or Stage IV Melanoma
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