Expired Study
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Sacramento, California 95816


Purpose:

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with cyclosporine and paclitaxel may be an effective treatment for non-Hodgkin's lymphoma. PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy combined with paclitaxel and cyclosporine in treating patients who have recurrent or refractory non-Hodgkin's lymphoma.


Study summary:

OBJECTIVES: - Determine the maximum tolerated dose of yttrium Y 90 monoclonal antibody Lym-1 in combination with paclitaxel and cyclosporine in patients with recurrent or refractory non-Hodgkin's lymphoma. OUTLINE: This is a dose-escalation study of yttrium Y 90 monoclonal antibody Lym-1 (Y90 MOAB Lym-1). Patients receive oral cyclosporine every 12 hours on days -2 to 14. Patients receive unlabeled MOAB Lym-1 IV followed by a tracer dose of indium In 111 MOAB Lym-1 IV on day 0. On day 7, patients receive unlabeled MOAB Lym-1 IV followed by Y90 MOAB Lym-1 IV. Patients in cohorts 2-4 also receive paclitaxel IV over 3 hours on day 9. Courses repeat every 8 weeks for a total of 3 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3 patients receive escalating doses of Y90 MOAB Lym-1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose-limiting toxicity. Patients are followed monthly for 3 months, every 3 months for 21 months, and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 36 months.


Criteria:

DISEASE CHARACTERISTICS: - Diagnosis of non-Hodgkin's lymphoma (NHL) that has failed standard first-line chemotherapy - Measurable disease - NHL tissue Lym-1 reactive in vitro - Normocellular bone marrow as evidenced by less than 25% of the bone marrow being NHL by bilateral bone marrow biopsy - No bone marrow evidence of myelodysplastic syndrome - HAMA titer negative PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 70-100% Life expectancy: - 3 to 6 months Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 130,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 mg/dL - AST no greater than 84 U/L Renal: - Creatinine less than 1.5 mg/dL OR - Creatinine clearance at least 50 mL/min Cardiovascular: - LVEF at least 50% Pulmonary: - FEV1 at least 60% of predicted - FVC at least 60% of predicted - DLCO at least 50% Other: - No other prior malignancy within the past 5 years except for nonmelanoma skin cancer - HIV negative - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - See Disease Characteristics - At least 4 weeks since prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - At least 4 weeks since prior external beam radiotherapy Surgery: - Not specified


NCT ID:

NCT00009776


Primary Contact:

Study Chair
Gerald L. DeNardo, MD
University of California, Davis


Backup Contact:

N/A


Location Contact:

Sacramento, California 95816
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 22, 2017

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