Trial of Melaxin Cancer Vaccine Plus Bacillus Calmette-Guerin (BCG) to Treat Malignant Melanoma
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|ClinicalTrials.gov Identifier: NCT00671554|
Recruitment Status : Terminated (Due to business considerations; not due to toxicities or adverse events.)
First Posted : May 5, 2008
Results First Posted : June 4, 2014
Last Update Posted : June 4, 2014
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Biological: Melaxin (autologous dendritoma vaccine) and BCG||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II, Open-Label Trial in Patients With Stage IV Malignant Melanoma Using Melaxin as a Cancer Vaccine in Conjunction With BCG|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||March 2009|
Experimental: Melaxin and BCG
Four 1 ml doses of 250,000 dendritomas SQ at 4 week intervals along with a separate SQ injection containing 1 million Colony Forming Units (CFU) of BCG. The dose of BCG will be decreased by 50% in subsequent dosing if there is injection site ulceration
Biological: Melaxin (autologous dendritoma vaccine) and BCG
Four 1 ml doses of 250,000 dendritomas SQ at 4 week intervals along with a separate SQ injection containing 1 million CFU of BCG. The dose of BCG will be decreased by 50% in subsequent dosing if there is injection site ulceration.
Other Name: Melaxin
- Safety as Measured by Number of Participants With Unexpected Adverse Events or Unexpected Laboratory Results. [ Time Frame: From first vaccine to 18 months after the last injection ]Expected adverse events included injection site reactions, fever, chills, and arthralgias as anticipated with vaccine therapy. No unexpected or uncommon adverse events occurred such as disseminated sepsis. Clinical laboratory results on all participants were within expected ranges, including an increase in the number of IFN gamma expressing T-cells.
- Tumor Response Measured by RECIST Criteria and Progression-free Survival. [ Time Frame: From first vaccine to 18 months after the last injection ]CT scans for disease assessment occurred at three month intervals. If partial or complete responses were observed confirmation scans were performed within four weeks. Patients were followed for 18 months post study completion. All three participants recieved at least one vaccine, and all participants had progression of disease prior to the 18 month followup visit.
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): NCT00671554
|United States, South Carolina|
|Cancer Center of Carolinas/Clinical Research Unit 3rd Floor|
|Greenville, South Carolina, United States, 29605|
|Study Director:||Thomas E Wagner, PhD||Greenville Hospital System|