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

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vical
• Treatments: Dacarbazine; Temozolomide

Criteria

Inclusion Criteria (Potential study participants must meet the following criteria):

• Confirmed Stage 3 or Stage 4 melanoma that may have had previous treatment via surgery, radiation or biologic drugs (typically Interferon Alpha or Interleukin-2)

• At least 1 melanoma tumor that is 1cm x 1cm or greater in size (about the size of a dime) and can be injected

• Normal blood chemistries and blood cell counts

• At least 18 years old and able and willing to provide informed consent to participate

Exclusion Criteria (Potential study participants will not be eligible with the following):

• Previous chemotherapy treatment for melanoma

• Melanoma lesions in the brain or liver (however, lesions in the lungs are allowed)

• If surgical removal of all lesions would be possible and could be curative

• Any melanoma tumors greater than 10cm x 10cm in size

• Known condition resulting in a suppressed immune system

• Female subjects who are pregnant