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Vaccination With Autologous Tumor Lysate-Pulsed Dendritic Cells - Phase I


Phase 1
18 Years
75 Years
Not Enrolling
Both
Lung Cancer

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Trial Information

Vaccination With Autologous Tumor Lysate-Pulsed Dendritic Cells - Phase I


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Timothy M. Anderson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000068881

NCT ID:

NCT00023985

Start Date:

January 2001

Completion Date:

August 2003

Related Keywords:

  • Lung Cancer
  • stage I non-small cell lung cancer
  • stage II non-small cell lung cancer
  • stage IIIA non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263