Non Hodgkin Lymphoma Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed diffuse large B-cell non-Hodgkin's lymphoma, including any of the following:

B-cell diffuse large cell variant
Immunoblastic
Mediastinal (thymic) large cell
T-cell/histiocyte-rich
Anaplastic large B-cell
Intravascular large B-cell
Lymphomatoid granulomatosis

Relapsed or refractory disease after at least 1 prior chemotherapy regimen and requires further treatment

Relapsed disease, defined as the following:

Appearance of any new lesion OR increase of at least 50% in the size of a previously involved site
50% increase in greatest diameter of any previously identified node greater than 1 cm in the short axis OR in the sum of the perpendicular diameter (SPD) of more than 1 node

Progressive disease, defined as the following:

50% increase from nadir in the SPD of any previously identified abnormal node
Appearance of any new lesion during or at the end of therapy
CD20-positive disease by immunohistochemistry

Bidimensionally measurable disease

At least 1 lesion at least 2.0 cm by CT scan
Less than 25% bone marrow involvement by lymphoma
No transformed lymphoma from indolent to aggressive
No HIV- or AIDS-related lymphoma
No hypocellular bone marrow
No marked reduction in bone marrow precursors of 1 or more cell lines (e.g., granulocytic, megakaryocytic, or erythroid)
No CNS lymphoma
Ineligible for myeloablative therapy OR refused transplantation
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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

25

Study ID:

NCT00073957

Recruitment Status:

Completed

Sponsor:

Beth Israel Deaconess Medical Center

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There are 2 Locations for this study

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Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
Fletcher Allen Health Care - Medical Center Campus
Burlington Vermont, 05401, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

25

Study ID:

NCT00073957

Recruitment Status:

Completed

Sponsor:


Beth Israel Deaconess Medical Center

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