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

Alternate Title

Vaccine Therapy and Chemotherapy With or Without Tretinoin in Treating Patients With Extensive-Stage Small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Biomarker/Laboratory analysis, Treatment	Active	18 and over	NCI, Pharmaceutical / Industry	MCC-15206 MCC-IRB-9792, MCC 15206, INTROGEN-RAC-0705-857, NCT00618891

Objectives

Primary

1. To determine if the combination of autologous dendritic cell-adenovirus p53 vaccine and subsequent chemotherapy (with paclitaxel after progression) will result in a substantial improvement in the clinical response in patients with extensive stage small cell lung cancer.
2. To determine if the addition of tretinoin to autologous dendritic cell-adenovirus p53 vaccine improves the objective tumor response rate achieved with the vaccine, by comparing the response to vaccine treatment of patients in arm II to those in arm III.
3. To evaluate the survival of all patients enrolled on an intent-to-treat basis, with a comparison made between the three arms.

Secondary

1. To determine the frequency of antigen-specific T-cell responses that are induced in the patients over time, with comparisons made between treatment arms II and III.
2. To determine the efficacy of tretinoin in reducing the number of immature myeloid cells in patients, by comparing the numbers observed in the peripheral blood of patients in arm II as compared to arm III.

Entry Criteria

Disease Characteristics:

• Histologically confirmed extensive stage small cell lung cancer (SCLC)



• No uncontrolled CNS metastases

Prior/Concurrent Therapy:

Inclusion criteria:

• At least 2 weeks since prior radiotherapy
• At least 4 weeks since prior and no concurrent steroid therapy
  • No anticipated requirement for chronic steroids at the time of vaccination

Patient Characteristics:

Inclusion criteria:

• ECOG performance status 0-2
• WBC > 3,000/mm³
• ANC > 1,500/mm³
• Platelets > 100,000/mm³
• Hematocrit > 25%
• Bilirubin < 2.0 mg/dL
• Creatinine < 2.0 mg/dL
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

Exclusion criteria:

• Serious ongoing infection
• Other pre-existing immunodeficiency condition including known HIV infection
• Known pre-existing autoimmune disorder
• History of a second malignancy within the past 5 years, except nonmelanoma skin cancer

Expected Enrollment

Outcomes

Complete response rate
Overall response rate

Comparison of survival rate between all arms
Toxicity

Outline

• Standard first-line chemotherapy: Patients receive standard first-line chemotherapy comprising carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for up to 4 courses. Patients undergo restaging after completion of first-line chemotherapy. Patients with progressive disease do not receive any protocol treatment and are changed to second-line therapy.



• Adjuvant therapy: Patients with stable disease or better are then randomized to 1 of 3 arms of adjuvant therapy approximately 3 weeks after completion of first-line chemotherapy.
  • Arm I (Observation only [standard care]): Patients undergo observation with serial CT scans.
  
  
  
  • Arm II (Vaccine): Patients receive autologous dendritic cell-adenovirus p53 vaccine intradermally every 2 weeks for 3 doses. Patients with no sign of disease progression will undergo another leukapheresis and receive autologous dendritic cell-adenovirus p53 vaccine intradermally every 4 weeks for 3 doses.
  
  
  
  • Arm III (Vaccine and tretinoin): Patients receive autologous dendritic cell-adenovirus p53 vaccine for up to 6 doses as in arm II. They also receive oral tretinoin for 3 days before receiving each dose of the vaccine.
  
  
  

Patients who develops evidence of disease progression at any point proceed to second-line chemotherapy with paclitaxel once every 21 days in the absence of disease progression or unacceptable toxicity.

All patients undergo blood collection periodically for immunogenic analysis. After completion of study treatment, patients are followed for at least 30 days.

Trial Contact Information

Trial Lead Organizations

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

Alberto Chiappori, MD, Protocol chair		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		A Randomized Phase II Trial Using Dendritic Cells Transduced With an Adenoviral Vector Containing the p53 Gene to Immunize Patients With Extensive Stage Small Cell Lung Cancer in Combination With Chemotherapy With or Without All Trans Retinoic Acid
Trial Start Date		2007-07-02
Trial Completion Date		2012-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00618891
Date Submitted to PDQ		2007-12-24
Information Last Verified		2008-08-11
NCI Grant/Contract Number		CA76292

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