Non Hodgkin Lymphoma Clinical Trial
Monoclonal Antibody Therapy, Paclitaxel, and Cyclosporine in Treating Patients With Recurrent or Refractory Non-Hodgkin’s Lymphoma
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.
Full 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.
Eligibility 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
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There is 1 Location for this study
Sacramento California, 95816, United States
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