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

Sponsor:	H. Lee Moffitt Cancer Center and Research Institute
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00049218

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Vaccines made from a gene-modified virus may make the body build an immune response to kill tumor cells. Combining vaccine therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy followed by adenovirus p53 vaccine therapy in treating patients who have extensive-stage small cell lung cancer.

Condition	Intervention	Phase
Lung Cancer	Biological: autologous dendritic cell-adenovirus p53 vaccine Drug: carboplatin Drug: etoposide	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Etoposide Carboplatin Etoposide phosphate

U.S. FDA Resources

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

Primary Outcome Measures:

Tumor response rate [ Designated as safety issue: No ]
Time to progression and survival [ Designated as safety issue: No ]

Estimated Enrollment:	58
Study Start Date:	July 2002

Detailed Description:

OBJECTIVES:

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.
Determine the toxicity of this regimen in these patients.
Determine the development of an anti-p53-specific immune response in these patients after treatment with this regimen.
Determine the tumor response rate, time to progression, and overall survival of patients treated with this regimen.
Determine the frequency of anti-adenovirus immune responses in these patients after treatment with this regimen.

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.

PROJECTED ACCRUAL: 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.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed small cell lung cancer
- Extensive stage disease
Measurable disease
No uncontrolled CNS metastasis

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-2

Life expectancy

Not specified

Hematopoietic

WBC greater than 3,000/mm^3
Absolute neutrophil count greater than 1,500/mm^3
Platelet count greater than 100,000/mm^3
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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00049218

Locations

United States, Florida
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States, 33612-9497

Sponsors and Collaborators

H. Lee Moffitt Cancer Center and Research Institute

Investigators

Study Chair:

Scott J. Antonia, MD, PhD

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:	CDR0000257814, MCC-13427, MCC-6260, MCC-IRB-0147/NE, MCC-0205538, MCC-12614
Study First Received:	November 12, 2002
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00049218 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

extensive stage small cell lung cancer

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Carcinoma, Neuroendocrine
Antineoplastic Agents
Neoplasms, Nerve Tissue
Carboplatin
Pharmacologic Actions
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors

Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Adenocarcinoma
Antineoplastic Agents, Phytogenic
Etoposide
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 25, 2009