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Vaccine Therapy in Treating Patients With Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00023985
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 7, 2011
Sponsor:
Information provided by:
Roswell Park Cancer Institute

Study Description
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Brief Summary:

RATIONALE: Vaccines made from a person's tumor cells and white blood cells may make the body build an immune response to kill tumor cells.

PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have non-small cell lung cancer.


Condition or disease Intervention/treatment Phase
Lung Cancer Biological: autologous tumor cell vaccine Biological: therapeutic autologous dendritic cells Procedure: conventional surgery Phase 1

Detailed Description:

OBJECTIVES:

  • Determine the safety and feasibility of immunization with autologous tumor lysate-pulsed dendritic cell vaccine in patients with non-small cell lung cancer.
  • Determine the immunologic response in patients treated with this vaccine.

OUTLINE: Patients undergo surgery to remove all or most of the gross evidence of tumor. Two months after surgery (or 4 months if chemotherapy and/or radiotherapy are required), patients undergo leukapheresis. Peripheral blood mononuclear cells are isolated and cultured with interleukin-4 and sargramostim (GM-CSF) to generate dendritic cells (DC). DC are then pulsed with tumor lysate prepared from previously removed tumor. Patients receive autologous tumor lysate-pulsed DC vaccine subcutaneously twice, 4 weeks apart.

Patients are followed every 4 months for 2 years, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 2 years.

Study Design
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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Vaccination With Autologous Tumor Lysate-Pulsed Dendritic Cells - Phase I
Study Start Date : January 2001
Actual Primary Completion Date : July 2003
Actual Study Completion Date : August 2003

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of operable stage IB, II, or IIIA non-small cell lung cancer

    • Tumor diameter of at least 3 cm

PATIENT CHARACTERISTICS:

Age:

  • 18 to 75

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 3 months

Hematopoietic:

  • WBC at least 3,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 2.0 mg/dL
  • AST less than 2 times upper limit of normal (ULN)
  • Lactate dehydrogenase less than 2 times ULN
  • Hepatitis B and C negative

Renal:

  • Creatinine no greater than 1.4 mg/dL

Other:

  • Positive cell mediated immunity test (i.e., greater than 5 mm induration in 48 hours with purified protein derivative (of tuberculin), candida, and mumps intradermal injection skin test)
  • HIV negative
  • No active systemic infection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior biological materials

Chemotherapy:

  • At least 4 weeks since prior cytotoxic or chemotherapeutic agents
  • Concurrent chemotherapy allowed after surgery and before vaccination

Endocrine therapy:

  • No concurrent steroid therapy

Radiotherapy:

  • At least 4 weeks since prior radiotherapy
  • Concurrent radiotherapy allowed after surgery and before vaccination

Surgery:

  • See Disease Characteristics
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00023985


Locations
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United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
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Study Chair: Timothy M. Anderson, MD Roswell Park Cancer Institute
More Information
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Responsible Party: Timothy Anderson, MD, Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00023985    
Other Study ID Numbers: CDR0000068881
RPCI-RP-9907
NCI-G01-2007
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: March 7, 2011
Last Verified: March 2011
Keywords provided by Roswell Park Cancer Institute:
stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases