Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Recurrent Primary CNS Lymphoma - Full Text View

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00082836

Purpose

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.

Condition	Intervention
Lymphoma	Biological: rituximab Radiation: yttrium Y 90 ibritumomab tiuxetan

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Pilot Study of Radiolabeled Indium-111 and Yttrium-90 Ibritumomab Tiuxetan in Primary CNS Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Rituximab Ibritumomab tiuxetan

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Dosimetry at 1, 24, and 48 hours [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety by NCI common toxicty criteria [ Designated as safety issue: Yes ]
Radiographic response at 1 and 3 months [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	January 2004

Detailed Description:

OBJECTIVES:

Primary

Determine the absorbed radiation doses of CNS lesions after administration of indium In 111 ibritumomab tiuxetan (for imaging) in patients with recurrent primary CNS lymphoma.

Secondary

Determine the safety of a therapeutic dose of yttrium Y 90 ibritumomab tiuxetan in these patients.

Tertiary

Determine the radiographic response in patients treated with this drug.

OUTLINE: Patients receive rituximab IV on day 1. Within 4 hours after rituximab administration, patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes. Patients then undergo whole body imaging. Patients whose dosimetry indicates that their CNS lesion would receive a sufficient radioimmunotherapy dose receive a therapeutic dose of yttrium Y 90 ibritumomab tiuxetan IV over 20-30 minutes on day 7.

Patients are followed monthly for 3 months, every 3 months for 2 years, and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00082836

Locations

United States, New York
Memorial Sloan - Kettering Cancer Center
New York, New York, United States, 10021

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Lauren E. Abrey, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000360857, MSKCC-04009
Study First Received:	May 14, 2004
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00082836 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

primary central nervous system lymphoma

Study placed in the following topic categories:

Antibodies, Monoclonal
Lymphatic Diseases
Antibodies
Immunoproliferative Disorders
Immunologic Factors
Rituximab

Central Nervous System Lymphoma, Primary
Antirheumatic Agents
Lymphoproliferative Disorders
Lymphoma
Recurrence
Immunoglobulins

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Rituximab
Physiological Effects of Drugs
Pharmacologic Actions

Antibodies, Monoclonal
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Lymphoproliferative Disorders
Antirheumatic Agents
Lymphoma

ClinicalTrials.gov processed this record on September 03, 2009