Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Biomarker/Laboratory analysis, Treatment	Active	18 and over	NCI	MCC-14744 MCC 14744, MCC-104490, MCC-0534-NE, NIH-OBA-0608-801, NCT00601796

Objectives

Primary

1. 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

1. To evaluate patients for the development of specific anti-tumor immune responses after immunization.
2. 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.
3. To evaluate the survival of patients treated with this vaccine.

Entry 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

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

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

Expected Enrollment

Outcomes

Tumor response

Time to progression
Survival

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.

Trial Contact Information

Trial Lead Organizations

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

Alberto Chiappori, MD, Principal investigator		Ph: 813-745-3050; 888-663-3488

U.S.A.
Florida
	Tampa
	H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
		Clinical Trials Office - H. Lee Moffitt Cancer Center and Reseach Institute	Ph:  800-456-7121
			Email: canceranswers@moffitt.org

Registry Information
Official Title		Combination Immunotherapy for Lung Cancer
Trial Start Date		2006-10-12 (estimated)
Trial Completion Date		2008-03-25 (estimated)
Registered in ClinicalTrials.gov		NCT00601796
Date Submitted to PDQ		2008-01-07
Information Last Verified		2008-08-11
NCI Grant/Contract Number		CA76292

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