Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Closed 18 and over Other UCD-991869 NCI-V00-1641, NCT00009776

Objectives

1. 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.

Entry 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

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

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/mm³
• Platelet count at least 130,000/mm³

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

Expected Enrollment

A total of 24 patients will be accrued for this study within 36 months.

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.

Trial Contact Information

Trial Lead Organizations

University of California Davis Cancer Center

Gerald DeNardo, MD, Protocol chair		Ph: 916-734-3787

Registry Information
Official Title		Combined Modality Radioimmunotherapy For Non-Hodgkin's Lymphoma With Three Cycles Of 90Y-DOTA-peptide-Lym-1, Paclitaxel and Cyclosporin A
Trial Start Date		2001-03-27
Registered in ClinicalTrials.gov		NCT00009776
Date Submitted to PDQ		2000-11-13
Information Last Verified		2001-10-09