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

Vical

Status and phase: Completed; Phase 3

Conditions: Metastatic Melanoma

Treatments: Drug: Dacarbazine (DTIC); Drug: Temozolomide (TMZ); Biological: Allovectin-7®

Study type: Interventional

Funder types: Industry

Identifiers

NCT00395070

LX01-315

Details and patient eligibility

About

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.

Full 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.

Enrollment: 390 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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390 participants in 2 patient groups

Treatment Arm

Experimental group

Description:

Allovectin-7® 2 mg intralesional injection into a single lesion weekly for six consecutive weeks, repeated beginning after each 8th week.

Treatment:

Biological: Allovectin-7®

Control Arm

Active Comparator group

Description:

DTIC 1000 mg/m2 intravenous infusion over 60 minutes, repeated every 28 days, OR TMZ 150 to 200 mg/m2 orally once daily for five consecutive days, repeated every 28 days.

Treatment:

Drug: Temozolomide (TMZ)

Drug: Dacarbazine (DTIC)