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Status:

TERMINATED

Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Non-Hodgkin's Lymphoma

Lead Sponsor:

Beth Israel Deaconess Medical Center

Conditions:

Lymphoma

Eligibility:

All Genders

18-120 years

Phase:

PHASE2

Brief Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others, such as yttrium Y 90 ibritumomab tiux...

Detailed Description

OBJECTIVES: Primary * Determine 12-week overall and complete response rate in patients with indolent non-Hodgkin's lymphoma treated with rituximab and yttrium Y 90 ibritumomab tiuxetan as first-line...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed indolent non-Hodgkin's lymphoma (NHL), including 1 of the following histologic subtypes:
  • Grade1 or 2 follicular lymphoma
  • Small lymphocytic lymphoma (SLL)
  • Marginal zone B-cell lymphoma
  • CD20-positive disease confirmed by immunohistochemistry or flow cytometry
  • Bidimensionally measurable disease
  • At least 1 lesion measuring ≥ 2.0 cm in a single dimension by CT scan
  • Less than 25% bone marrow involvement with lymphoma by bilateral iliac crest bone marrow aspiration and biopsy within the past 6 weeks
  • No clinically significant impaired bone marrow reserve as evidenced by any of the following:
  • Hypocellular marrow, as evidenced by 1 of the following:
  • ≤ 15% cellularity
  • Marked reduction in bone marrow precursors
  • Platelet count \< 100,000/mm\^3
  • Absolute neutrophil count \< 1,500/mm\^3
  • History of failed stem cell collection
  • Prior myeloablative therapy
  • No greater than 5,000/mm\^3 circulating tumor cells in peripheral blood
  • Requires antilymphoma therapy, as indicated by any of the following:
  • Systemic symptoms
  • B symptoms
  • Cytopenias
  • Malaise
  • Organ compromise
  • Discomfort
  • Pain
  • Disfigurement
  • Rapidly progressive disease
  • Undue anxiety related to not receiving treatment
  • No transformation to intermediate or high-grade NHL
  • No known brain metastases or CNS involvement by lymphoma NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
  • PATIENT CHARACTERISTICS:
  • Age
  • Over 18
  • Performance status
  • ECOG 0-2 OR
  • WHO 0-2 OR
  • Karnofsky 70-100%
  • Life expectancy
  • More than 3 months
  • Hematopoietic
  • See Disease Characteristics
  • WBC ≥ 3,000/mm\^3
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Lymphocyte count \< 5,000/mm\^3 (for patients with SLL )
  • Hepatic
  • Bilirubin ≤ 2.0 mg/dL
  • AST and ALT ≤ 2.5 times upper limit of normal
  • Renal
  • Creatinine ≤ 2.0 mg/dL OR
  • Creatinine clearance \> 60 mL/min
  • Cardiovascular
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • Immunologic
  • No anti-murine antibody reactivity (in patients with prior exposure to murine antibodies or proteins)
  • No ongoing or active infection
  • No history of allergic reaction attributed to compounds of similar chemical or biologic composition to yttrium Y 90 ibritumomab tiuxetan
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 1 year after study treatment
  • No other active malignancy except non-melanoma skin cancer
  • No other serious nonmalignant disease that would preclude study participation
  • No psychiatric illness or social situation that would preclude study compliance
  • No other uncontrolled illness
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • More than 4 weeks since prior pegfilgrastim
  • More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)
  • Chemotherapy
  • No prior chemotherapy
  • Endocrine therapy
  • Not specified
  • Radiotherapy
  • No prior external beam radiotherapy to \> 25% of active bone marrow (involved field or regional)
  • Surgery
  • More than 4 weeks since prior major surgery except diagnostic surgery
  • Other
  • No prior systemic antilymphoma therapy
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent anticancer therapy
  • No other concurrent investigational agents
  • No other concurrent antilymphoma therapy

Exclusion

    Key Trial Info

    Start Date :

    May 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    March 1 2015

    Estimated Enrollment :

    12 Patients enrolled

    Trial Details

    Trial ID

    NCT00110149

    Start Date

    May 1 2004

    End Date

    March 1 2015

    Last Update

    November 21 2017

    Active Locations (3)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (3 locations)

    1

    Beth Israel Deaconess Medical Center

    Boston, Massachusetts, United States, 02215

    2

    Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, United States, 03756-0002

    3

    Vermont Cancer Center at University of Vermont

    Burlington, Vermont, United States, 05401-3498