NCT00395070

A Phase 3 Pivotal Trial Comparing Allovectin-7® Alone vs Chemotherapy Alone in Patients With Stage 3 or Stage 4 Melanoma

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 390 (actual)
• Sponsor: Vical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Metastatic Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	Allovectin-7®	Allovectin-7® 2 mg intralesional injection into a single lesion weekly for six consecutive weeks, repeated beginning after each 8th week.
DRUG	Dacarbazine (DTIC)	1000 mg/m2 intravenous infusion over 60 minutes, repeated every 28 days, OR
DRUG	Temozolomide (TMZ)	150 to 200 mg/m2 orally once daily for five consecutive days, repeated every 28 days.

Timeline

• Start date: 2006-10-01
• Primary completion: 2012-03-01
• Completion: 2013-07-01
• First posted: 2006-11-02
• Last updated: 2013-09-13

Locations

88 sites across 14 countries: United States, Belgium, Brazil, Canada, France, Germany, Israel, Italy, Netherlands, Poland, Russia, Spain, Switzerland, Turkey (Türkiye)