Tracking Information
Start Date ICMJE | October 2006 |
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Estimated Primary Completion Date | January 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 History | Complete list of historical versions of study NCT00395070 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: July 25, 2008) |
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Original Secondary Outcome Measures ICMJE (submitted: October 31, 2006) |
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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 |
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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 Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Metastatic Melanoma |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 375 | ||||||||
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Estimated Completion Date | July 2010 | ||||||||
Estimated Primary Completion Date | January 2010 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria (Potential study participants must meet the following criteria):
Exclusion Criteria (Potential study participants will not be eligible with the following):
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Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Belgium, Brazil, Canada, Croatia, France, Germany, Israel, Italy, Netherlands, Poland, Russian Federation, Spain, Switzerland, Turkey |
Administrative Information
NCT ID ICMJE | NCT00395070 | ||||
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Responsible Party | Linda Strause, PHD, Executive Director, Clinical Oncology, Vical Incorporated | ||||
Study ID Numbers ICMJE | LX01-315 | ||||
Study Sponsor ICMJE | Vical | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Vical |