Status:
COMPLETED
A Phase 3 Pivotal Trial Comparing Allovectin-7® Alone vs Chemotherapy Alone in Patients With Stage 3 or Stage 4 Melanoma
Lead Sponsor:
Vical
Conditions:
Metastatic Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
390 Patients enrolled
Trial Details
Trial ID
NCT00395070
Start Date
October 1 2006
End Date
July 1 2013
Last Update
September 13 2013
Active Locations (88)
Enter a location and click search to find clinical trials sorted by distance.
1
Location #40
Tucson, Arizona, United States, 85724
2
Location #9
Little Rock, Arkansas, United States, 72205
3
Location #1
Bakersfield, California, United States, 93309
4
Location #24
San Diego, California, United States, 92093