A Phase 3 Pivotal Trial Comparing Allovectin-7® Alone vs Chemotherapy Alone in Patients With Stage 3 or Stage 4 Melanoma
To compare the safety and efficacy of Allovectin-7® versus Dacarbazine (DTIC)or Temozolomide (TMZ) in subjects with recurrent stage 3 or stage 4 melanoma.
Drug: Dacarbazine (DTIC)
Drug: Temozolomide (TMZ)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Treatment With 2 mg Intralesional Allovectin-7® Compared to Dacarbazine (DTIC) or Temozolomide (TMZ) in Subjects With Recurrent Metastatic Melanoma|
- To compare the overall response rate at ≥24 weeks after randomization in the Allovectin-7® arm versus the control (DTIC/TMZ) arm. [ Time Frame: After all 375 subjects are enrolled ] [ Designated as safety issue: No ]
- To investigate the safety/tolerability of Allovectin-7® in comparison to DTIC/TMZ. [ Time Frame: After all 375 subjects are enrolled ] [ Designated as safety issue: Yes ]
- To investigate the effect of Allovectin-7® in comparison to DTIC-TMZ on overall survival. [ Time Frame: After all 375 subjects are enrolled ] [ Designated as safety issue: No ]
|Study Start Date:||October 2006|
|Estimated Study Completion Date:||August 2013|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
|Experimental: Treatment Arm||
Allovectin-7® 2 mg intralesional injection into a single lesion weekly for six consecutive weeks, repeated beginning after each 8th week.
|Active Comparator: Control Arm||
Drug: Dacarbazine (DTIC)
DTIC 1000 mg/m2 intravenous infusion over 60 minutes, repeated every 28 days, ORDrug: Temozolomide (TMZ)
150 to 200 mg/m2 orally once daily for five consecutive days, repeated every 28 days.
Eligible patients will have a 66% chance of receiving Allovectin-7® alone (an investigational product designed to train your body's immune system to recognize and destroy tumor cells) vs. a 33% chance of receiving standard chemotherapy (either dacarbazine or temozolomide). The treatment course recommended for patients who receive Allovectin-7® is a minimum of 16 weeks. Each cycle will consist of weekly injections of Allovectin-7® alone for six weeks followed by two weeks of observation and assessments. For patients who receive the chemotherapy alone, their treatment course will follow standard dosing. During the trial all patients' tumors will be closely monitored. Patients whose melanoma does not clinically progress will be encouraged to continue on the treatment and be assessed for up to two years.
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|Study Director:||Linda Strause, PHD||Vical|