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

Alternate Title

Chemotherapy Followed By Vaccine Therapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Closed	18 and over	Other	MCC-13427 MCC-6260, MCC-IRB-0147/NE, MCC-0205538, MCC-12614, NCT00049218

Objectives

1. Determine the maximum tolerated dose of autologous dendritic cell-adenovirus p53 vaccine, administered after standard chemotherapy, in patients with extensive stage small cell lung cancer.
2. Determine the toxicity of this regimen in these patients.
3. Determine the development of an anti-p53-specific immune response in these patients after treatment with this regimen.
4. Determine the tumor response rate, time to progression, and overall survival of patients treated with this regimen.
5. Determine the frequency of anti-adenovirus immune responses in these patients after treatment with this regimen.

Entry Criteria

Disease Characteristics:

• Histologically confirmed small cell lung cancer
  • Extensive stage disease



• Measurable disease



• No uncontrolled CNS metastasis

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• At least 4 weeks since prior steroids (before vaccination)
• No concurrent chronic steroids (during vaccination)

Radiotherapy

• At least 2 weeks since prior radiotherapy (before vaccination)

Surgery

• Not specified

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• WBC greater than 3,000/mm³
• Absolute neutrophil count greater than 1,500/mm³
• Platelet count greater than 100,000/mm³
• Hematocrit greater than 25%

Hepatic

• Bilirubin less than 2.0 mg/dL

Renal

• Creatinine less than 2.0 mg/dL

Immunologic

• HIV negative
• No serious ongoing infection
• No pre-existing immunodeficiency
• No known pre-existing autoimmune disorder

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 6 months after study participation

Expected Enrollment

A total of 43-58 patients (3-18 for phase I and 40 for phase II) will be accrued for this study within 3 years.

Outcomes

Tumor response rate
Time to progression and survival

Outline

This is a dose-escalation study of autologous dendritic cell-adenovirus p53 vaccine.

Patients undergo leukapheresis and dendritic cells are cultured. Adenovirus carrying p53 gene particles are added to the dendritic cells to make the vaccine. Leukapheresis is performed before chemotherapy or 8 weeks after the last dose of chemotherapy if the patient has already started chemotherapy.

Patients receive standard chemotherapy before receiving the vaccine. The recommended regimen is 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 6 courses in the absence of disease progression or unacceptable toxicity.

Patients with progressive disease (PD) at 6 weeks after chemotherapy are removed from the study.

• Phase I: Beginning 9 weeks after completion of chemotherapy, patients receive autologous dendritic cell-adenovirus p53 vaccine subcutaneously (SC) on days 1, 14, and 28. Patients without PD may undergo repeat leukapheresis on day 49. Patients receive vaccine SC again on days 56, 84, and 112 in the absence of disease progression or unacceptable toxicity.

  Cohorts of 3-6 patients receive escalating doses of autologous dendritic cell-adenovirus p53 vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.




• Phase II: Patients receive autologous dendritic cell-adenovirus p53 vaccine at the MTD determined in phase I.

Patients are followed at day 140 and then every 3 months thereafter.

Trial Contact Information

Trial Lead Organizations

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

Scott Antonia, MD, PhD, Protocol chair		Ph: 813-972-8400, ext. 2677; 888-663-3488

Registry Information
Official Title		A Phase I-II Trial Using Dendritic Cells Transduced With An Adenoviral Vector Containing The p53 Gene To Immunize Patients With Extensive Stage Small Cell Lung Cancer After Standard Chemotherapy
Trial Start Date		2002-07-30
Registered in ClinicalTrials.gov		NCT00049218
Date Submitted to PDQ		2002-09-03
Information Last Verified		2007-10-11

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