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.

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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.

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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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Study ID:

NCT00009776

Recruitment Status:

Unknown status

Sponsor:

University of California, Davis

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There is 1 Location for this study

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University of California Davis Cancer Center
Sacramento California, 95816, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Study ID:

NCT00009776

Recruitment Status:

Unknown status

Sponsor:


University of California, Davis

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