Monoclonal Antibody Therapy, Paclitaxel, and Cyclosporine in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma

University of California, Davis

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Lymphoma

Interventions

monoclonal antibody Lym-1BIOLOGICAL

cyclosporineDRUG

paclitaxelDRUG

indium In 111 monoclonal antibody Lym-1RADIATION

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of California Davis Cancer Center

Sacramento, California, United States

Data from ClinicalTrials.gov

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