Universal Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)-Producing and CD40L Expressing Bystander Cell Line for Tumor Vaccine in Melanoma
|ClinicalTrials.gov Identifier: NCT00101166|
Recruitment Status : Completed
First Posted : January 10, 2005
Results First Posted : November 16, 2012
Last Update Posted : February 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Biological: Bystander-Based Autologous Tumor Cell Vaccine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial Using a Universal GM-CSF-Producing and CD40L-Expressing Bystander Cell Line (GM.CD40L) in the Formulation of Autologous Tumor Cell-Based Vaccines for Patients With Malignant Melanoma|
|Study Start Date :||October 2004|
|Primary Completion Date :||March 2010|
|Study Completion Date :||March 2010|
Experimental: Vaccine Therapy
Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.
Biological: Bystander-Based Autologous Tumor Cell Vaccine
The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm.
- Number of Participants With Partial Response [ Time Frame: Average of 14 months ]Response and progression were evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
- Number of Participants With Serious Adverse Events (SAEs) Related to Study Treatment [ Time Frame: Average of 14 months ]Frequency of Study Related Toxicity. To evaluate the toxicity of the autologous tumor cell / GM.CD40L bystander cell vaccine. Toxicity was scored using the NCI Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE-3).
- Number of Participants With Stable Disease [ Time Frame: Average of 14 months ]Patients with stable disease by RECIST criteria after 3 vaccine injections. Response and progression were evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
- Time to Progression (TTP) in Months [ Time Frame: Average of 14 months ]Response and progression were evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Progressive disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
- Overall Survival (OS) in Months [ Time Frame: Average of 14 months ]Average overall survival time in months.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00101166
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612-9497|
|Principal Investigator:||Sophie Dessureault, M.D., Ph.D.||H. Lee Moffitt Cancer Center and Research Institute|