NCT00082836

Brief Summary

RATIONALE: Monoclonal antibodies, such as rituximab and yttrium Y 90 ibritumomab tiuxetan, can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. PURPOSE: This clinical trial is studying how well giving yttrium Y 90 ibritumomab tiuxetan together with rituximab works in treating patients with recurrent primary CNS lymphoma.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable lymphoma

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

May 14, 2004

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 19, 2004

Completed
7 months until next milestone

Study Start

First participant enrolled

December 1, 2004

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Last Updated

January 17, 2013

Status Verified

January 1, 2013

Enrollment Period

2.4 years

First QC Date

May 14, 2004

Last Update Submit

January 15, 2013

Conditions

Lymphoma

Keywords

primary central nervous system non-Hodgkin lymphoma

Outcome Measures

Primary Outcomes (1)

  • Dosimetry at 1, 24, and 48 hours

Secondary Outcomes (2)

  • Safety by NCI common toxicty criteria

  • Radiographic response at 1 and 3 months

Interventions

rituximabBIOLOGICAL
yttrium Y 90 ibritumomab tiuxetanRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed non-Hodgkin's lymphoma (NHL) * Recurrent disease * Isolated CNS relapse of systemic NHL allowed * Primary CNS lymphoma * Measurable gadolinium-enhancing lesion on MRI of the brain * No impaired bone marrow reserve * No hypocellular bone marrow * No marked reduction in bone marrow precursors of one or more cell lines (granulocytic, megakaryocytic, erythroid) * No pleural effusion * No chronic lymphocytic leukemia * No AIDS-related lymphoma PATIENT CHARACTERISTICS: Age * Adult Performance status * Not specified Life expectancy * Not specified Hematopoietic * Platelet count \> 100,000/mm\^3 * Absolute neutrophil count ≥ 1,500/mm\^3 Hepatic * Bilirubin ≤ 2.0 mg/dL Renal * Creatinine ≤ 2.0 mg/dL Other * HIV negative * No serious nonmalignant disease that would preclude study participation * No infection * No anti-murine antibody reactivity\* * No human anti-mouse antibodies * Not pregnant * Negative pregnancy test NOTE: \*Results must be available prior to study entry for patients who received prior murine antibodies or proteins, other than rituximab PRIOR CONCURRENT THERAPY: Biologic therapy * See Radiotherapy * No prior stem cell transplantation * No prior myeloablative therapies with autologous bone marrow transplantation or peripheral blood stem cell rescue * No prior failed stem cell collection * More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF) Chemotherapy * No more than 1 prior chemotherapy regimen Endocrine therapy * Not specified Radiotherapy * No prior radioimmunotherapy * No prior whole-brain radiotherapy * No prior external beam radiotherapy (involved field or regional) to \> 25% of active bone marrow Surgery * More than 4 weeks since prior major surgery except diagnostic surgery

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

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan - Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Lymphoma

Interventions

Rituximabibritumomab tiuxetan

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Lauren E. Abrey, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 14, 2004

First Posted

May 19, 2004

Study Start

December 1, 2004

Primary Completion

May 1, 2007

Last Updated

January 17, 2013

Record last verified: 2013-01

Locations

US(1)