Vaccine Therapy, Tretinoin, and Cyclophosphamide in Treating Patients With Metastatic Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00601796|
Recruitment Status : Completed
First Posted : January 28, 2008
Results First Posted : May 15, 2013
Last Update Posted : May 24, 2013
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Biological: Vaccine Treatment Drug: Cyclophosphamide Drug: All-trans retinoic acid (ATRA)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Combination Immunotherapy for Lung Cancer|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
U.S. FDA Resources
Experimental: Combination Immunotherapy
Vaccine + Cytoxan + ATRA as outlined in Detailed Description
Biological: Vaccine Treatment
We created a vaccine in which irradiated allogeneic lung adenocarcinoma cells are combined with a bystander K562 cell line transfected with hCD40L and hGM-CSF. By recruiting and activating dendritic cells, we hypothesized the vaccine would induce tumor regression in metastatic lung adenocarcinoma. Intradermal vaccine was given every 14 days x3, followed by monthly x3.
Other Name: Allogeneic Tumor Cell-Based VaccinesDrug: Cyclophosphamide
Cyclophosphamide (300 mg/m^2 IV) was administered before 1st and 4th vaccines to deplete regulatory T-cells.
Other Name: cytoxanDrug: All-trans retinoic acid (ATRA)
All-trans retinoic acid was given (150/mg/m^2/day) after 1st and 4th vaccines to enhance dendritic differentiation.
- Number of Evaluable Participants With Tumor Response [ Time Frame: 3 years ]Number of participants with evaluable peripheral blood mononuclear cells (PBMCs) who demonstrated sustained tumor peptide-specific T-cell activation after vaccination. Peripheral blood mononuclear cells (PBMCs) were collected at baseline and after each vaccination. T-cell activation profiles were analyzed by ELISpot assay and tested by generalized Wilcoxon for correlation to survival.
- Median Time to Progression (TTP) [ Time Frame: 3 years ]
Analysis of Time to Progression and Survival Endpoints. All patients will be considered in the analysis of progression free survival time (time from start of treatment to progression or death) and survival time (time from initiation of treatment to death). Progression is defined using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of the longest diameter (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.
Follow-up for this analysis will continue for all patients for their lifetimes. Time to progression and survival probabilities over time will be calculated by the method of Kaplan-Meier.
- Median Overall Survival (OS) [ Time Frame: 3 years ]Analysis of Time to Progression and Survival Endpoints. All patients will be considered in the analysis of progression free survival time (time from start of treatment to progression or death) and survival time (time from initiation of treatment to death). Follow-up for this analysis will continue for all patients for their lifetimes. Time to progression and survival probabilities over time will be calculated by the method of Kaplan-Meier.
- Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: 3 years ]Toxicity will be assessed using the NCI Common Terminology Criteria for Adverse Criteria (CTAE-3),Version 3.0 (www.ctep.cancer.gov). Particular attention will assess the presence of symptomatic lymphadenopathy or any local skin / soft tissue reaction at the vaccine site. Blood tests for ANA and rheumatoid factor will be performed on any patient who develops evidence of autoimmune phenomena.
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): NCT00601796
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612-9497|
|Principal Investigator:||Alberto Chiappori, MD||H. Lee Moffitt Cancer Center and Research Institute|