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Vaccine Therapy, Tretinoin, and Cyclophosphamide in Treating Patients With Metastatic Lung Cancer
This study is currently recruiting participants.
Study NCT00601796   Information provided by National Cancer Institute (NCI)
First Received: January 19, 2008   Last Updated: February 6, 2009   History of Changes
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January 19, 2008
February 6, 2009
October 2006
Tumor response [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00601796 on ClinicalTrials.gov Archive Site
  • Time to progression [ Designated as safety issue: No ]
  • Survival [ Designated as safety issue: No ]
Same as current
 
Vaccine Therapy, Tretinoin, and Cyclophosphamide in Treating Patients With Metastatic Lung Cancer
Combination Immunotherapy for Lung Cancer

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.

OBJECTIVES:

Primary

  • To evaluate tumor response rate in patients with stage IV lung cancer receiving vaccine therapy comprising allogeneic tumor cells and GM.CD40L in combination with tretinoin and cyclophosphamide.

Secondary

  • To evaluate patients for the development of specific anti-tumor immune responses after immunization.
  • To quantitate the dendritic cell (DC):immature myeloid cell (ImC) ratio before and after treatment with tretinoin, vaccine therapy comprising allogeneic tumor cells and GM.CD40L, and cyclophosphamide.
  • To evaluate the survival of patients treated with this vaccine.

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.

Phase II
Interventional
Treatment, Open Label
Lung Cancer
  • Biological: GM.CD40L cell vaccine
  • Biological: allogeneic tumor cell vaccine
  • Drug: cyclophosphamide
  • Drug: tretinoin
  • Genetic: protein expression analysis
  • Other: flow cytometry
  • Other: immunoenzyme technique
  • Other: immunohistochemistry staining method
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
48
 
March 2008   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the lung

    • Metastatic disease
  • Measurable metastatic tumor as defined by standard RECIST criteria

    • Lesions must be accurately measured in at least 1 dimension with the longest diameter ≥ 20 mm (≥ 10 mm in at least 1 dimension by spiral CT scan)
  • Completed first-line chemotherapy
  • No symptomatic brain metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • WBC > 3,000/mm³
  • ANC > 1,500/mm³
  • Platelets > 100,000/mm³
  • Hematocrit > 25%
  • Bilirubin < 2.0 mg/dL
  • Creatinine < 2.0 mg/dL OR creatinine clearance > 60 mL/min
  • No acute medical problems requiring active intervention
  • No other pre-existing immunodeficiency condition (including known HIV infection)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No radiotherapy 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
  • No concurrent corticosteroids (other than replacement doses in patients who are hypoadrenal) or other immunosuppressive therapy
Both
18 Years and older
No
 
United States
 
 
NCT00601796
 
MCC-14744, MCC-104490, MCC-0534-NE, NIH-OBA-0608-801
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
National Cancer Institute (NCI)
August 2008

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††   WHO trial registration data element that is required only if it exists.