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

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

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:


  • 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.


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


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

    • Tumor diameter of at least 3 cm



  • 18 to 75

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 3 months


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


  • 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


  • Creatinine no greater than 1.4 mg/dL


  • 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


Biologic therapy:

  • At least 4 weeks since prior biological materials


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

Endocrine therapy:

  • No concurrent steroid therapy


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


  • See Disease Characteristics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00023985

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

Responsible Party: Timothy Anderson, MD, Roswell Park Cancer Institute Identifier: NCT00023985     History of Changes
Other Study ID Numbers: CDR0000068881
Study First Received: September 13, 2001
Last Updated: March 3, 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:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Immunologic Factors
Physiological Effects of Drugs processed this record on August 18, 2017