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Tracking Information | |||||
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First Received Date † | January 19, 2008 | ||||
Last Updated Date | February 6, 2009 | ||||
Start Date † | October 2006 | ||||
Current Primary Outcome Measures † |
Tumor response [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00601796 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Vaccine Therapy, Tretinoin, and Cyclophosphamide in Treating Patients With Metastatic Lung Cancer | ||||
Official Title † | Combination Immunotherapy for Lung Cancer | ||||
Brief Summary | RATIONALE: Vaccines made from tumor cells may help the body build an effective immune response to kill tumor cells. Biological therapies, such as tretinoin and cyclophosphamide, may change the immune system in different ways and help the vaccine work better at stop tumor cells from growing. PURPOSE: This phase II trial is studying how well giving vaccine therapy together with tretinoin and cyclophosphamide works in treating patients with metastatic lung cancer. |
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Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: Patients receive cyclophosphamide IV on days 1 and 57, vaccine (formulated by mixing allogeneic tumor cells and GM.CD40L) intradermally at 4 separate sites on days 4, 18, 32, 60, 88, and 116, and oral tretinoin three times daily on days 5-7 and days 61-63 in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease, partial response, or complete response receive the vaccine every 3 months until disease progression. Patients undergo blood collection periodically during treatment for immune response testing, including determination of dendritic cell (DC):immature myeloid cell (ImC) ratios by flow cytometry and ELISPOT analysis. Archived diagnostic biopsy tissue is analyzed for the expression of WT1, CEA, and hTERT by immunohistochemistry. After completion of study treatment, patients are followed periodically. |
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Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Open Label | ||||
Condition † | Lung Cancer | ||||
Intervention † |
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Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Estimated Enrollment † | 48 | ||||
Completion Date | |||||
Estimated Primary Completion Date | March 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00601796 | ||||
Responsible Party | |||||
Secondary IDs †† | MCC-14744, MCC-104490, MCC-0534-NE, NIH-OBA-0608-801 | ||||
Study Sponsor † | H. Lee Moffitt Cancer Center and Research Institute | ||||
Collaborators †† | National Cancer Institute (NCI) | ||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | August 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |