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


Tracking Information

Start Date  ICMJEOctober 2006
Estimated Primary Completion DateJanuary 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: July 25, 2008)		Variant of Progression Free Survival: Durable Response Rate (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 ]
Original Primary Outcome Measures  ICMJE 
 (submitted: October 31, 2006)		To compare the overall response rate at ≥24 weeks after randomization in the Allovectin-7® arm versus the control (DTIC/TMZ) arm.
Change HistoryComplete list of historical versions of study NCT00395070 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: July 25, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE 
 (submitted: October 31, 2006)
  • To investigate the safety/tolerability of Allovectin-7® in comparison to DTIC/TMZ.
  • To investigate the effect of Allovectin-7® in comparison to DTIC-TMZ on overall survival.

Descriptive Information

Brief Title  ICMJEA Phase 3 Pivotal Trial Comparing Allovectin-7® Alone vs Chemotherapy Alone in Patients With Stage 3 or Stage 4 Melanoma
Official Title  ICMJEA 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
Brief 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.

Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEMetastatic Melanoma
Intervention  ICMJE
  • 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)
    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.
Study Arms / Comparison Groups
  • Treatment Arm: Experimental
    Intervention: Biological: Allovectin-7®
  • Control Arm: Active Comparator
    Interventions:
    • Drug: Dacarbazine (DTIC)
    • Drug: Temozolomide (TMZ)

Recruitment Information

Estimated Enrollment  ICMJE375
Estimated Completion DateJuly 2010
Estimated Primary Completion DateJanuary 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Dmitri Kharkevitch, MD,PHD858-646-1164 or 1-877-343-6389melanoma@vical.com
Contact: Linda Strause, PHD858-646-1156 or 1-877-343-6389melanoma@vical.com
Location Countries  ICMJEUnited States,   Belgium,   Brazil,   Canada,   Croatia,   France,   Germany,   Israel,   Italy,   Netherlands,   Poland,   Russian Federation,   Spain,   Switzerland,   Turkey

Administrative Information

NCT ID  ICMJENCT00395070
Responsible PartyLinda Strause, PHD, Executive Director, Clinical Oncology, Vical Incorporated
Study ID Numbers  ICMJELX01-315
Study Sponsor  ICMJEVical
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Linda Strause, PHDVical
Information Provided ByVical