Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Waldenstrom's Macroglobulinemia

Lymphoma Clinical Trial

Official title:

Phase I Study of Zevalin (90Y-Ibritumomab Tiuxetan) in Waldenstrom's Macroglobulinemia (Lymphoplasmacytic Lymphoma)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00060294
• Other study ID #: CDR0000301591
• Secondary ID: UCLA-0202063IDEC
• Status: Terminated
• Phase: Phase 1
• First received: May 6, 2003
• Last updated: January 7, 2013
• Start date: April 2003

Study information

• Verified date: January 2013
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Monoclonal antibodies such as yttrium Y 90 ibritumomab tiuxetan and rituximab can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells.

PURPOSE: Phase I trial to study the effectiveness of yttrium Y 90 ibritumomab tiuxetan in treating patients who have Waldenstrom's macroglobulinemia.

Description:

OBJECTIVES:

• Determine the maximum tolerated dose of yttrium Y 90 ibritumomab tiuxetan in patients with Waldenstrom's macroglobulinemia.

• Determine, preliminarily, the response of patients treated with this drug.

OUTLINE: This is a multicenter, dose-escalation study of yttrium Y 90 ibritumomab tiuxetan (IDEC-Y2B8).

Patients receive rituximab IV and indium In 111 ibritumomab tiuxetan (IDEC-In2B8) IV over 10 minutes on day 1. Patients then undergo gamma camera scans within 2-24 hours. Approximately 7-14 days after IDEC-In2B8, patients receive rituximab IV and IDEC-Y2B8 IV over 10 minutes. Treatment with IDEC-Y2B8 may repeat every 12 weeks in the absence of unacceptable toxicity or the achievement of a maximum cumulative dose.

Cohorts of 3-6 patients receive escalating doses of IDEC-Y2B8 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 3 months for 4 years.

PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. primary completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of Waldenstrom's macroglobulinemia confirmed by IgM gammopathy and bone marrow biopsy

• Presence of lymphoplasmacytic cells

• CD20+ plasma cell dyscrasia on the majority of malignant cells

• Bone marrow involvement of 20-50% by core needle biopsy of at least 1.5 cm in length

• Clinical indication for initiation of treatment, including 1 or more of the following characteristics:

• Symptoms associated with the disease (e.g., fatigue, asthenia, or painful adenopathy)

• Anemia

• IgM greater than 3 g/L

• Progression as indicated by a rate of IgM rise of more than 0.5 g over 6 months

• No myelodysplastic syndromes or profound hypocellularity of the bone marrow

PATIENT CHARACTERISTICS:

Age

• Over 18

Performance status

• WHO 0-2

Life expectancy

• More than 3 months

Hematopoietic

• Absolute neutrophil count greater than 1,500/mm^3

• Total B-lymphocyte count less than 5,000/mm^3

• Platelet count greater than 100,000/mm^3

• No hyperviscosity syndrome

Hepatic

• Bilirubin no greater than 1.5 mg/dL

Renal

• Not specified

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 1 year after study completion

• No uncontrolled CNS disease

• No serious nonmalignant disease that would preclude study participation

• No other concurrent active malignancy except controlled skin cancer or prostate cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

• More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)

• More than 4 months since prior rituximab

• No prior radioimmunotherapy

Chemotherapy

• No prior high-dose chemotherapy (unless patient has had prior back-up stem cell collections)

• More than 6 weeks since prior chemotherapy

Endocrine therapy

• More than 4 weeks since prior corticosteroids

Radiotherapy

• No prior radiotherapy

Surgery

• Not specified

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Waldenstrom Macroglobulinemia

Intervention

Biological:
• rituximab

Radiation:
• yttrium Y 90 ibritumomab tiuxetan

Locations

Country	Name	City	State
United States	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute	Boston	Massachusetts
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,