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

NCT00395070 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 390

Last updated 2013-09-13

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Vical

    lead INDUSTRY

Principal Investigators

  • Linda Strause, PhD · Vical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2012-03-31
Completion
2013-07-31

Countries

  • United States
  • Belgium
  • Brazil
  • Canada
  • France
  • Germany
  • Israel
  • Italy
  • Netherlands
  • Poland
  • Russia
  • Spain
  • Switzerland
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00395070 on ClinicalTrials.gov