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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Metastatic Melanoma

Intervention / Treatment
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* Biological: Allovectin-7®
* Drug: Dacarbazine (DTIC)
* Drug: Temozolomide (TMZ)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm<br>Allovectin-7® 2 mg intralesional injection into a single lesion weekly for six consecutive weeks, repeated beginning after each 8th week. | Biological: Allovectin-7®<br>* Allovectin-7® 2 mg intralesional injection into a single lesion weekly for six consecutive weeks, repeated beginning after each 8th week.<br>|
| Active Comparator: Control Arm<br>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. | Drug: Dacarbazine (DTIC)<br>* 1000 mg/m2 intravenous infusion over 60 minutes, repeated every 28 days, OR<br>Drug: Temozolomide (TMZ)<br>* 150 to 200 mg/m2 orally once daily for five consecutive days, repeated every 28 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the overall response rate at ≥24 weeks after randomization in the Allovectin-7® arm versus the control (DTIC/TMZ) arm. |  | After all 375 subjects are enrolled | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the safety/tolerability of Allovectin-7® in comparison to DTIC/TMZ. |  | After all 375 subjects are enrolled | 
| To investigate the effect of Allovectin-7® in comparison to DTIC-TMZ on overall survival. |  | After all 375 subjects are enrolled | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Melanoma, DTIC, TMZ, Stage 3, Stage 4, Metastatic, Metastatic Melanoma (Stage 3, Stage 4 Melanoma)