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

This study has been completed.
Sponsor:
Information provided by:
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00023985
First received: September 13, 2001
Last updated: March 3, 2011
Last verified: March 2011
  Purpose

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 Intervention Phase
Lung Cancer
Biological: autologous tumor cell vaccine
Biological: therapeutic autologous dendritic cells
Procedure: conventional surgery
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Vaccination With Autologous Tumor Lysate-Pulsed Dendritic Cells - Phase I

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Study Start Date: January 2001
Study Completion Date: August 2003
Primary Completion Date: July 2003 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00023985

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Study Chair: Timothy M. Anderson, MD Roswell Park Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Timothy Anderson, MD, Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00023985     History of Changes
Other Study ID Numbers: CDR0000068881, RPCI-RP-9907, NCI-G01-2007
Study First Received: September 13, 2001
Last Updated: March 3, 2011
Health Authority: United States: Federal Government

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:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 16, 2014