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.

Los Angeles, California 90095


Purpose:

RATIONALE: Vaccines made from a person's tumor cells and white blood cells may make the body build an effective immune response to kill tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients who are undergoing surgery for stage IB, stage II, or stage IIIA non-small cell lung cancer.


Study summary:

OBJECTIVES: Primary - Determine the maximum tolerated dose of adjuvant autologous dendritic cells loaded with irradiated autologous tumor cells in patients with stage IB-IIIA non-small cell lung cancer undergoing resection. - Determine the safety and tolerability of this vaccine in these patients. Secondary - Determine the feasibility of this vaccine in these patients. - Determine vaccine-specific and antitumor immunity in patients treated with this vaccine. OUTLINE: This is a dose-escalation study. Patients undergo leukaphersis to isolate peripheral blood mononuclear cells (PBMC). PBMC are expanded ex vivo to generate monocyte-derived dendritic cells (DC). Autologous tumor cells are harvested and purified at the time of surgical resection. DC are then loaded with irradiated autologous tumor cells. Within 4-8 weeks after surgical resection, patients receive autologous DC loaded with irradiated autologous tumor cells intradermally on approximately days 1, 30, and 60 in the absence of unacceptable toxicity. Cohorts of 6-9 patients receive escalating doses of vaccine until the maximum tolerated dose (MTD) is determined. If 2 of 9 patients in the first cohort experience dose-limiting toxicity, that dose level is considered the MTD. Patients are followed at approximately 1 and 4 months, and then every 6 months for 4 years. PROJECTED ACCRUAL: A total of 12-15 patients will be accrued for this study within 18 months.


Criteria:

DISEASE CHARACTERISTICS: - Diagnosis of non-small cell lung cancer - Clinical stage IB-IIIA disease - Candidate for surgical resection as primary treatment for tumor - Surgically resectable tumor ≥ 2.0 cm in diameter - No brain metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Zubrod 0-1 Life expectancy - Not specified Hematopoietic - Platelet count ≥ 100,000/mm^3 - WBC ≥ 3,000/mm^3 - Absolute neutrophil count ≥ 1,500/mm^3 - Hematocrit ≥ 30% Hepatic - Hepatitis B surface antigen negative* - Hepatitis B core antigen negative* - Hepatitis C virus negative* - Bilirubin ≤ 2.0 mg/dL - AST and ALT ≤ 2 times upper limit of normal NOTE: *Screening performed only if liver enzymes are elevated Renal - Creatinine ≤ 2.2 mg/dL - BUN ≤ 40 mg/dL Pulmonary - FEV_1 > 2.0 L (pre-resection) OR - Predicted post-resection FEV_1 > 1.0 L - No more than 2 chronic obstructive pulmonary disease exacerbations requiring > 2 weeks of oral steroids and/or hospitalization within the past year Immunologic - Purified protein derivative (PPD) skin test negative - HIV-1 and HIV-2 negative - No acute infection, including any acute viral, bacterial, or fungal infection requiring specific therapy within the past 7 days - No allergy to study agents - No known autoimmune or collagen vascular disorder Other - Not pregnant or nursing - Fertile patients must use effective contraception - No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix - No underlying condition that would preclude study therapy PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent anti-tumor necrosis factor agents Chemotherapy - Standard adjuvant chemotherapy for lung cancer allowed provided therapy is completed ≥ 30 days before administration of the first study vaccine - No concurrent cyclophosphamide Endocrine therapy - No concurrent high-dose corticosteroids (e.g., > 10 mg of prednisone) - Concurrent corticosteroids for minor breathing exacerbations allowed provided patient receives ≤ 2 short courses (≤ 10 days per course) within a 45-day period - No concurrent corticosteroids within 48 hours before or after study vaccine administration Radiotherapy - Standard adjuvant radiotherapy for lung cancer allowed provided therapy is completed ≥ 30 days before administration of the first study vaccine Surgery - No prior organ allograft Other - No concurrent antihistamines within 48 hours before or after study vaccine administration - No concurrent cimetidine or other H2 blockers within 48 hours before or after study vaccine administration - Concurrent antibiotics for minor infection allowed provided patient receives ≤ 2 short courses (≤ 10 days per course) within a 45-day period - No concurrent cyclosporine - No concurrent azathioprine - No other concurrent drugs known to significantly alter immune function - No concurrent cytotoxic therapy - No concurrent participation in another clinical trial involving experimental therapy - No other concurrent anticancer therapy


NCT ID:

NCT00098917


Primary Contact:

Principal Investigator
Michael D. Roth, MD
Jonsson Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Los Angeles, California 90095
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 15, 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.