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


Phase 1
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Christos E. Emmanouilides, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000301591

NCT ID:

NCT00060294

Start Date:

April 2003

Completion Date:

Related Keywords:

  • Lymphoma
  • Waldenström macroglobulinemia
  • Lymphoma
  • Waldenstrom Macroglobulinemia

Name

Location

Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115