|
|
|
|
|
|
Sponsors and Collaborators: |
H. Lee Moffitt Cancer Center and Research Institute National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00601796 |
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.
Condition | Intervention | Phase |
Lung Cancer |
Drug: GM.CD40L cell vaccine Drug: allogeneic tumor cell vaccine Drug: cyclophosphamide Drug: tretinoin Procedure: flow cytometry Procedure: immunoenzyme technique Procedure: immunohistochemistry staining method Procedure: protein expression analysis |
Phase II |
MedlinePlus related topics: | Cancer Lung Cancer |
Drug Information available for: | Cyclophosphamide Tretinoin CD40 Ligand |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Combination Immunotherapy for Lung Cancer |
Estimated Enrollment: | 48 |
Study Start Date: | October 2006 |
Estimated Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the lung
Measurable metastatic tumor as defined by standard RECIST criteria
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Florida | |||||
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | Recruiting | ||||
Tampa, Florida, United States, 33612-9497 | |||||
Contact: Clinical Trials Office - H. Lee Moffitt Cancer Center and Rese 800-456-7121 canceranswers@moffitt.org |
H. Lee Moffitt Cancer Center and Research Institute |
National Cancer Institute (NCI) |
Principal Investigator: | Alberto Chiappori, MD | H. Lee Moffitt Cancer Center and Research Institute |
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
Study ID Numbers: | CDR0000581417, MCC-14744, MCC-104490, MCC-0534-NE, NIH-OBA-0608-801 |
First Received: | January 19, 2008 |
Last Updated: | October 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00601796 |
Health Authority: | Unspecified |
|
|
|
|
|