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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

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Metastatic Melanoma Biological: Allovectin-7® Drug: Dacarbazine (DTIC) Drug: Temozolomide (TMZ) Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 390 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2006
Actual Primary Completion Date : March 2012
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment Arm
Allovectin-7® 2 mg intralesional injection into a single lesion weekly for six consecutive weeks, repeated beginning after each 8th week.
 Biological: Allovectin-7®
Allovectin-7® 2 mg intralesional injection into a single lesion weekly for six consecutive weeks, repeated beginning after each 8th week.
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To investigate the safety/tolerability of Allovectin-7® in comparison to DTIC/TMZ. [ Time Frame: After all 375 subjects are enrolled ]
  2. To investigate the effect of Allovectin-7® in comparison to DTIC-TMZ on overall survival. [ Time Frame: After all 375 subjects are enrolled ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00395070


Locations
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Sponsors and Collaborators
Vical
Investigators
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Study Director: Linda Strause, PhD Vical
More Information
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Additional Information:

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Responsible Party: Vical
ClinicalTrials.gov Identifier: NCT00395070    
Other Study ID Numbers: LX01-315
First Posted: November 2, 2006    Key Record Dates
Last Update Posted: September 13, 2013
Last Verified: September 2013
Keywords provided by Vical:
Melanoma
DTIC
TMZ
Stage 3
 Stage 4
Metastatic
Metastatic Melanoma (Stage 3, Stage 4 Melanoma)
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
 Nevi and Melanomas
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents