Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Recurrent Primary CNS Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Treatment	Completed	Adult	NCI	MSKCC-04009 NCT00082836

Objectives

Primary

1. 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

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

Tertiary

1. Determine the radiographic response in patients treated with this drug.

Entry 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

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

Patient Characteristics:

Age

• Adult

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Platelet count > 100,000/mm³
• Absolute neutrophil count ≥ 1,500/mm³

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]

Expected Enrollment

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

Outcomes

Dosimetry at 1, 24, and 48 hours

Safety by NCI common toxicty criteria
Radiographic response at 1 and 3 months

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.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Lauren Abrey, MD, Principal investigator		Ph: 212-639-5122; 800-525-2225 Email: abreyl@mskcc.org

Registry Information
Official Title		A Pilot Study of Radiolabeled Indium-111 and Yttrium-90 Ibritumomab Tiuxetan in Primary CNS Lymphoma
Trial Start Date		2004-01-27
Registered in ClinicalTrials.gov		NCT00082836
Date Submitted to PDQ		2004-03-03
Information Last Verified		2007-09-16
NCI Grant/Contract Number		CA08748

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