Chemotherapy With or Without Immunotherapy in Treating Patients With Stage III or Stage IV Melanoma

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Injecting allovectin-7 into a person's melanoma cells may make the body build an immune response that will kill tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of dacarbazine with or without immunotherapy in treating patients who have stage III or stage IV melanoma.

Detailed Description
-----------------
OBJECTIVES: I. Demonstrate either an improvement in the median time to disease progression by at least 2 months with no decrease in the rate of objective clinical response OR an improvement by at least 15% in the rate of objective clinical response with no decrease in the median time to disease progression in patients with stage III or IV melanoma receiving dacarbazine with Allovectin-7 when compared with patients receiving dacarbazine alone. II. Determine the benefits, risks, and side effects of these regimens in this patient population. PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to sex, age, and spread of disease (cutaneous or nodal vs visceral disease). Patients are randomized to one of two treatment arms. Arm I: Patients receive dacarbazine IV over 1 hour on day 0. Arm II: Patients receive treatment as in arm I. Patients also receive Allovectin-7 intratumorally on days 3 and 10. Patients with stable or responding disease may receive additional courses every 28 days. Patients are followed every 4 months. PROJECTED ACCRUAL: A total of 280 patients (140 in each arm) will be accrued for this study.

Official Title
-----------------
Phase III Randomized Study of Dacarbazine With or Without Allovectin-7 in Patients With Metastatic Melanoma

Conditions
-----------------
Stage IV Melanoma, Stage III Melanoma, Recurrent Melanoma

Intervention / Treatment
-----------------
* Drug: allovectin-7
* Drug: allovectin-7/dacarbazine
* Drug: dacarbazine


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically confirmed stage III or IV melanoma 1 or more metastatic tumors for which surgery is not deemed to be a curative option Dacarbazine is indicated as first line chemotherapy At least 1 measurable tumor at least 1 cm2 but no greater than 100 cm2 No history of brain metastases --Prior/Concurrent Therapy-- Biologic therapy: At least 4 weeks since prior biologic therapy Chemotherapy: See Disease Characteristics; No 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 experimental therapy --Patient Characteristics-- Age: 18 and over Performance status: Karnofsky 80-100% Life expectancy: At least 24 weeks 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 (ULN); PT/PTT normal; Albumin normal; LDH no greater than 2 times ULN 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; Not pregnant or nursing; 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 within the past 5 years except skin cancer or stage 0-II cervical cancer; No significant psychiatric disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years


Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

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

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