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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00023985
• Other study ID #: CDR0000068881
• Secondary ID: RPCI-RP-9907NCI-
• Status: Completed
• Phase: Phase 1
• First received: September 13, 2001
• Last updated: March 3, 2011
• Start date: January 2001
• Est. completion date: August 2003

Study information

• Verified date: March 2011
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: August 2003
• Est. primary completion date: July 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Biological:
• autologous tumor cell vaccine

• therapeutic autologous dendritic cells

Procedure:
• conventional surgery

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States,