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Vaccine Therapy in Treating Patients With Non-Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
Study NCT00023985   Information provided by National Cancer Institute (NCI)
First Received: September 13, 2001   Last Updated: February 6, 2009   History of Changes

September 13, 2001
February 6, 2009
January 2001
 
 
 
Complete list of historical versions of study NCT00023985 on ClinicalTrials.gov Archive Site
 
 
 
Vaccine Therapy in Treating Patients With Non-Small Cell Lung Cancer
Vaccination With Autologous Tumor Lysate-Pulsed Dendritic Cells - Phase I

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.

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.

Phase I
Interventional
Treatment
Lung Cancer
  • Biological: autologous tumor cell vaccine
  • Biological: therapeutic autologous dendritic cells
  • Procedure: conventional surgery
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00023985
 
CDR0000068881, RPCI-RP-9907, NCI-G01-2007
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Study Chair: Timothy M. Anderson, MD Roswell Park Cancer Institute
National Cancer Institute (NCI)
December 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP