Full Text View
Tabular View
No Study Results Posted
Related Studies
Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Relapsed or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), July 2009
First Received: December 10, 2003   Last Updated: July 7, 2009   History of Changes
Sponsor: Beth Israel Deaconess Medical Center
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00073957
  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.


Condition Intervention Phase
Lymphoma
Biological: rituximab
Drug: cytarabine
Drug: liposomal cytarabine
Drug: methotrexate
Radiation: yttrium Y 90 ibritumomab tiuxetan
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Zevalin And Rituxan For The Treatment Of Relapsed Or Refractory Diffuse Large B-Cell Non-Hodgkin's Lymphoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Response rate (complete response, unconfirmed complete response, and partial response) at 12 weeks [ Designated as safety issue: No ]
  • Event-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: December 2003
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00073957

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Clinical Trials Office - Beth Israel Deaconess Medical Center     617-667-9925        
United States, Vermont
Fletcher Allen Health Care - Medical Center Campus Recruiting
Burlington, Vermont, United States, 05401
Contact: Clinical Trials Office - Fletcher Allen Heakth Care     802-656-8990        
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Study Chair: Robin Joyce, MD Beth Israel Deaconess Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Beth Israel Deaconess Medical Center ( Robin Joyce )
Study ID Numbers: CDR0000341437, BIDMC-2003P-000182
Study First Received: December 10, 2003
Last Updated: July 7, 2009
ClinicalTrials.gov Identifier: NCT00073957     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent adult diffuse large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
anaplastic large cell lymphoma

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Reproductive Control Agents
Antibodies, Monoclonal
Lymphoma, B-Cell
Therapeutic Uses
Abortifacient Agents
Methotrexate
Dermatologic Agents
Lymphoma
Nucleic Acid Synthesis Inhibitors
Cytarabine
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Rituximab
Enzyme Inhibitors
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Antirheumatic Agents

ClinicalTrials.gov processed this record on November 09, 2009