NCT00060294

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 6, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2003

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2004

Completed
Last Updated

January 8, 2013

Status Verified

January 1, 2013

Enrollment Period

1.2 years

First QC Date

May 6, 2003

Last Update Submit

January 7, 2013

Conditions

Lymphoma

Keywords

Waldenström macroglobulinemia

Interventions

rituximabBIOLOGICAL
yttrium Y 90 ibritumomab tiuxetanRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

LymphomaWaldenstrom Macroglobulinemia

Interventions

Rituximabibritumomab tiuxetan

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Christos E. Emmanouilides, MD

    Jonsson Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2003

First Posted

May 7, 2003

Study Start

April 1, 2003

Primary Completion

June 1, 2004

Last Updated

January 8, 2013

Record last verified: 2013-01

Locations

US(2)