Chemotherapy With or Without Immunotherapy in Treating Patients With Stage III or Stage IV Melanoma
|ClinicalTrials.gov Identifier: NCT00003647|
Recruitment Status : Completed
First Posted : March 23, 2004
Last Update Posted : July 25, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Stage IV Melanoma Stage III Melanoma Recurrent Melanoma||Drug: allovectin-7 Drug: allovectin-7/dacarbazine Drug: dacarbazine||Phase 3|
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.
A total of 280 patients (140 in each arm) will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase III Randomized Study of Dacarbazine With or Without Allovectin-7 in Patients With Metastatic Melanoma|
|Study Start Date :||July 1998|
|Actual Study Completion Date :||September 2002|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003647
|Study Chair:||Cherie Smith||Vical|