Y 90 Ibritumomab Tiuxetan &Rituximab Relapsed or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma

NCT ID: NCT00073957

Last Updated: 2018-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-12-31
• Study Completion Date: 2012-01-01

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. Combining yttrium Y 90 ibritumomab tiuxetan with rituximab may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining yttrium Y 90 Ibritumomab tiuxetan with rituximab in treating patients who have relapsed or refractory diffuse large B-cell non-Hodgkin's lymphoma.

Detailed Description

OBJECTIVES:

• Determine the best overall response in patients with relapsed or refractory diffuse large B-cell non-Hodgkin's lymphoma treated with yttrium Y 90 ibritumomab tiuxetan and rituximab.
• Determine the event-free survival of patients treated with this regimen.
• Determine the toxicity of this regimen in these patients.

OUTLINE: This is an open-label, multicenter study.

• Radioimmunotherapy: Patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1 (for imaging only); yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8; and rituximab IV over 3-4 hours on days 1, 8, 15, 22, 29, and 36.
• CNS ( central nervous system)prophylaxis: Patients receive CNS prophylaxis comprising intrathecal (IT) methotrexate or IT cytarabine on days 15, 22, 29, and 36 OR IT cytarabine (liposomal) on days 15 and 29.
• Maintenance rituximab: Patients are assessed for response at week 14. Beginning at month 6, patients with stable or responding disease receive maintenance therapy comprising rituximab IV over 3-4 hours once weekly for 4 weeks. Maintenance therapy repeats every 6 months for 2 years (total of 4 courses) in the absence of disease progression or unacceptable toxicity.

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

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.

Conditions

Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Y-90 Ibritumomab Tiuxetan

Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab and central nervous system prophylaxis with Cytarabine or liposomal cytarabine

Group Type: EXPERIMENTAL

rituximab

Intervention Type: BIOLOGICAL

cytarabine

Intervention Type: DRUG

to be used for CNS prophylaxis

liposomal cytarabine

Intervention Type: DRUG

to be used as CNS prophylaxis

yttrium Y 90 ibritumomab tiuxetan

Intervention Type: RADIATION

Interventions

rituximab

Intervention Type: BIOLOGICAL

cytarabine

to be used for CNS prophylaxis

Intervention Type: DRUG

liposomal cytarabine

to be used as CNS prophylaxis

Intervention Type: DRUG

yttrium Y 90 ibritumomab tiuxetan

Intervention Type: RADIATION

Other Intervention Names

Rituxan; cytosine arabinoside; Depocyte; Zevalin

Eligibility Criteria

Inclusion Criteria

• Ineligible for any other open yttrium Y 90 ibritumomab tiuxetan investigational protocols

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• WHO 0-2

Life expectancy

• At least 3 months

Hematopoietic

• Absolute neutrophil count at least 1,500/mm^3
• Lymphocyte count no greater than 5,000/mm^3 (for patients with small lymphocytic lymphoma)
• Platelet count at least 100,000/mm^3

Hepatic

• Bilirubin no greater than 2.0 mg/dL

Renal

• Creatinine no greater than 2.0 mg/dL

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 1 year after study participation
• No concurrent serious nonmalignant disease or infection that would preclude study participation
• No human antimurine antibody reactivity

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics
• No prior autologous bone marrow transplantation
• No prior peripheral blood stem cell rescue
• No prior failed stem cell collection
• Prior rituximab within the past 90 days allowed provided patient has fludeoxyglucose-avid disease that is also indium In 111 ibritumomab tiuxetan-avid disease in at least 1 lesion
• More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• Not specified

Radiotherapy

• No prior radioimmunotherapy
• No prior external beam radiotherapy (involved field or regional) to more than 25% of active bone marrow

Surgery

• More than 4 weeks since prior major surgery (except diagnostic surgery)

Other

• Recovered from all prior therapy
• More than 4 weeks since prior therapy for lymphoma
• More than 8 weeks since prior phase II investigational drugs
• No other concurrent antineoplastic therapy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Robin Joyce

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robin Joyce, MD

Role: STUDY_CHAIR

Beth Israel Deaconess Medical Center

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Fletcher Allen Health Care - Medical Center Campus

Burlington, Vermont, United States

Countries

United States

Other Identifiers

CDR0000341437

Identifier Type: REGISTRY

Identifier Source: secondary_id

2003P000182

Identifier Type: -

Identifier Source: org_study_id