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

NCT ID: NCT00023985

Last Updated: 2011-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-01-31
• Study Completion Date: 2003-08-31

Brief 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.

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.

Conditions

Lung Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

autologous tumor cell vaccine

Intervention Type: BIOLOGICAL

therapeutic autologous dendritic cells

Intervention Type: BIOLOGICAL

conventional surgery

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Roswell Park Cancer Institute

Principal Investigators

Timothy M. Anderson, MD

Role: STUDY_CHAIR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Countries

United States

Other Identifiers

RPCI-RP-9907

Identifier Type: -

Identifier Source: secondary_id

NCI-G01-2007

Identifier Type: -

Identifier Source: secondary_id

CDR0000068881

Identifier Type: -

Identifier Source: org_study_id