Gene Therapy in Treating Patients With Stage III or Stage IV Melanoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase II Study of Allovectin-7 as an Immunotherapeutic Agent in Patients With Stages III and IV Melanoma

Conditions
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Stage IV Melanoma, Stage III Melanoma, Recurrent Melanoma

Intervention / Treatment
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* Drug: allovectin-7


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years


Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: allovectin-7|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adult solid tumor, body system/site cancer, cancer, melanoma, recurrent melanoma, skin tumor, solid tumor, stage III melanoma, stage IV melanoma, stage, melanoma