Vaccine Therapy, Tretinoin, and Cyclophosphamide in Treating Patients With Metastatic Lung Cancer
Combination Immunotherapy for Lung Cancer
3 other identifiers
interventional
24
1 country
1
Brief Summary
The purpose of this study is to find out what effects (good and/or bad) a tumor vaccine used in combination with two drugs (ATRA and cytoxan) have on the patient and their cancer. We also want to find out if the vaccine and the drugs can boost the patient's immune system and how their immune system reacts, both before and after the vaccine treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 lung-cancer
Started Oct 2006
Typical duration for phase_2 lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 19, 2008
CompletedFirst Posted
Study publicly available on registry
January 28, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedResults Posted
Study results publicly available
May 15, 2013
CompletedMay 24, 2013
February 1, 2013
5.7 years
January 19, 2008
February 27, 2013
May 15, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Evaluable Participants With Tumor Response
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.
3 years
Secondary Outcomes (3)
Median Time to Progression (TTP)
3 years
Median Overall Survival (OS)
3 years
Number of Participants With Serious Adverse Events (SAEs)
3 years
Study Arms (1)
Combination Immunotherapy
EXPERIMENTALVaccine + Cytoxan + ATRA as outlined in Detailed Description
Interventions
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.
Cyclophosphamide (300 mg/m\^2 IV) was administered before 1st and 4th vaccines to deplete regulatory T-cells.
All-trans retinoic acid was given (150/mg/m\^2/day) after 1st and 4th vaccines to enhance dendritic differentiation.
Eligibility Criteria
You may qualify if:
- Histologically confirmed metastatic adenocarcinoma of the lung
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, or 1
- No radiation therapy within 2 weeks of first vaccine administration
- No chemotherapy within 4 weeks of first vaccine administration
- No steroid therapy within 4 weeks of first vaccine administration
- Patient's written informed consent
- Adequate organ function (measured within a week of beginning treatment)
- Measurable metastatic tumor as defined by standard Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Lesions must be accurately measured in at least one dimension with the longest diameter greater than or equal 20mm. With spiral computer tomography (CT) scan, lesion must be greater than or equal to 10 mm at least one dimension.
- Patient's must have received, and completed first line chemotherapy.
You may not qualify if:
- Symptomatic brain metastasis
- Any acute medical problems requiring active intervention
- Current corticosteroid (other than replacement doses in patients who are hypoadrenal) or other immunosuppressive therapy
- Any other pre-existing immunodeficiency condition (including known HIV infection)
- Pregnant or lactating women -- Patients in reproductive age must agree to use contraceptive methods for the duration of the study (\*A pregnancy test will be obtained before treatment).
- Eastern Cooperative Oncology Group (ECOG) performance status of 2, 3 or 4
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Alberto Chiappori, M.D.
- Organization
- H. Lee Moffitt Cancer Center and Research Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Alberto Chiappori, MD
H. Lee Moffitt Cancer Center and Research Institute
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2008
First Posted
January 28, 2008
Study Start
October 1, 2006
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
May 24, 2013
Results First Posted
May 15, 2013
Record last verified: 2013-02