Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Buffalo, New York 14263


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00023985


Primary Contact:

Study Chair
Timothy M. Anderson, MD
Roswell Park Cancer Institute


Backup Contact:

N/A


Location Contact:

Buffalo, New York 14263
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 24, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.