Phase II FANG™ in Advanced 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: NCT01453361|
Recruitment Status : Terminated (Business Decision to pursue other indications)
First Posted : October 17, 2011
Results First Posted : May 11, 2018
Last Update Posted : May 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Advanced Melanoma||Biological: Vigil™ Vaccine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of FANG™ Autologous Tumor Cell Vaccine in Advanced Melanoma|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||March 22, 2016|
|Actual Study Completion Date :||March 22, 2016|
Experimental: Vigil™ Vaccine
Autologous Vigil™ vaccine will be supplied by Gradalis, Inc. Patients will receive 1 x 10e7 cells via intradermal injection one day each month for a minimum maximum of 12 doses as long as subject is clinically stable.
Biological: Vigil™ Vaccine
Other Name: formerly known as FANG™
- Enzyme-Linked ImmunoSorbent Spot (ELISPOT) [ Time Frame: Baseline, End of Treatment (30 days after last dose) up to 12 months ]To determine if subjects will have a positive (defined as >10 ELISPOTS from baseline) immune response to Vigil. Blood was collected to compare ELISPOT results from baseline until EOT (30 days after last dose).
- Number of Alive Subjects [ Time Frame: 3 years ]The survival status in patients with stages IIIc and IV melanoma treated with Vigil™ vaccine was determined by following these patients up to 3 years.
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): NCT01453361
|United States, Texas|
|Mary Crowley Cancer Research Centers|
|Dallas, Texas, United States, 75230|
|Principal Investigator:||Minal Barve, MD||Mary Crowley Cancer Research Center|