Overview

This trial is active, not recruiting.

Condition lymphoma
Treatments monoclonal antibody lym-1, cyclosporine, paclitaxel, indium in 111 monoclonal antibody lym-1, yttrium y 90 monoclonal antibody lym-1
Phase phase 1
Sponsor University of California, Davis
Start date March 2001
Trial identifier NCT00009776, CDR0000068371, NCI-V00-1641, UCD-991869

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Primary purpose treatment

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Combined Modality Radioimmunotherapy For Non-Hodgkin's Lymphoma With Three Cycles Of 90Y-DOTA-peptide-Lym-1, Paclitaxel and Cyclosporin A
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).