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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00395070
Recruitment Status : Completed
First Posted : November 2, 2006
Last Update Posted : September 13, 2013
Sponsor:
Information provided by (Responsible Party):
Vical

Tracking Information
First Submitted Date  ICMJE October 31, 2006
First Posted Date  ICMJE November 2, 2006
Last Update Posted Date September 13, 2013
Study Start Date  ICMJE October 2006
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2013)		 To compare 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 ]
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 History
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 ]
  • To investigate the effect of Allovectin-7® in comparison to DTIC-TMZ on overall survival. [ Time Frame: After all 375 subjects are enrolled ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2006)
  • To investigate the effect of Allovectin-7® in comparison to DTIC-TMZ on overall survival.
  • To investigate the safety/tolerability of Allovectin-7® in comparison to DTIC/TMZ.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 3 Pivotal Trial Comparing Allovectin-7® Alone vs Chemotherapy Alone in Patients With Stage 3 or Stage 4 Melanoma
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Metastatic 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)
    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  ICMJE
  • Experimental: Treatment Arm
    Allovectin-7® 2 mg intralesional injection into a single lesion weekly for six consecutive weeks, repeated beginning after each 8th week.
    Intervention: Biological: Allovectin-7®
  • Active Comparator: Control Arm
    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.
    Interventions:
    • Drug: Dacarbazine (DTIC)
    • Drug: Temozolomide (TMZ)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 11, 2013)		 390
Original Enrollment  ICMJE
 (submitted: October 31, 2006)		 375
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date March 2012   (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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Brazil,   Canada,   France,   Germany,   Israel,   Italy,   Netherlands,   Poland,   Russian Federation,   Spain,   Switzerland,   Turkey,   United States
Removed Location Countries Croatia
 
Administrative Information
NCT Number  ICMJE NCT00395070
Other Study ID Numbers  ICMJE LX01-315
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Vical
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Vical
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Linda Strause, PhD Vical
PRS Account Vical
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP