Vaccine Therapy, Tretinoin, and Cyclophosphamide in Treating Patients With Metastatic Lung Cancer - Full Text View

Sponsor:	H. Lee Moffitt Cancer Center and Research Institute
Collaborator:	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	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	Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cyclophosphamide Tretinoin

U.S. FDA Resources

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

Additional Information:

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

No publications provided

Study ID Numbers:	CDR0000581417, MCC-14744, MCC-104490, MCC-0534-NE, NIH-OBA-0608-801
Study First Received:	January 19, 2008
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00601796 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the lung
stage IV non-small cell lung cancer

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Cyclophosphamide
Immunosuppressive Agents
Pharmacologic Actions
Keratolytic Agents
Neoplasms

Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Myeloablative Agonists
Tretinoin
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Dermatologic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on November 27, 2009