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Vaccine Therapy, Tretinoin, and Cyclophosphamide in Treating Patients With Metastatic Lung Cancer

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), August 2008

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
  Purpose

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   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   Combination Immunotherapy for Lung Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Tumor response [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression [ Designated as safety issue: No ]
  • Survival [ Designated as safety issue: No ]

Estimated Enrollment:   48
Study Start Date:   October 2006
Estimated Primary Completion Date:   March 2008 (Final data collection date for primary outcome measure)

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00601796

Locations
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    

Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI)

Investigators
Principal Investigator:     Alberto Chiappori, MD     H. Lee Moffitt Cancer Center and Research Institute    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

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

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the lung  
stage IV non-small cell lung cancer  

Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Adenocarcinoma of lung
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Tretinoin
Cyclophosphamide
Adenocarcinoma
Carcinoma, Non-Small-Cell Lung

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Keratolytic Agents
Neoplasms
Neoplasms by Site
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Dermatologic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on October 28, 2008




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