Clinical Trials /

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

NCT00073957

Description:

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.

Related Conditions:
  • Anaplastic Large Cell Lymphoma
  • Angioimmunoblastic T-Cell Lymphoma
  • Diffuse Large B-Cell Lymphoma
  • Mediastinal Large B-Cell Lymphoma
  • T-Cell Non-Hodgkin Lymphoma
Recruiting Status:

Completed

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title:Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Relapsed or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma
  • Official Title:Zevalin And Rituxan For The Treatment Of Relapsed Or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma

Clinical Trial IDs

  • ORG STUDY ID: CDR0000341437
  • SECONDARY ID: BIDMC-2003P-000182
  • NCT ID: NCT00073957

Trial Conditions

  • Lymphoma

Trial Interventions

DrugSynonymsArms
cytarabine
liposomal cytarabine
methotrexate

Trial Purpose

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 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.

Trial Arms

NameTypeDescriptionInterventions

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

Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Both
Healthy Volunteers:No

Primary Outcome Measures

Measure:Response rate (complete response, unconfirmed complete response, and partial response) at 12 weeks
Time Frame:
Safety Issue:No
Description:

Secondary Outcome Measures

Trial Keywords

  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • anaplastic large cell lymphoma