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External Beam Radiotherapy and Zevalin for Management of Indolent B-Cell Non-Hodgkin's Lymphoma
This study is currently recruiting participants.
Verified by The Cleveland Clinic, December 2005
Sponsored by: The Cleveland Clinic
Information provided by: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00271050
  Purpose

The purpose of the research study is to learn whether external beam radiation can be used as a safe and effective treatment for patients with bulky (≥ 5cm) sites of non-Hodgkin's lymphoma prior to treatment with 90Y-ibritumomab tiuxetan (Zevalin).


Condition Intervention Phase
Lymphoma, B-Cell
Procedure: external beam radiotherapy
Phase I

MedlinePlus related topics: Lymphoma
Drug Information available for: Ibritumomab tiuxetan
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: The Role of Conformal External Beam Radiotherapy in the Management of Patients With Bulky Disease Undergoing Y90-Ibritumomab Tiuxetan (Zevalin) Radio-Immunotherapy for Indolent B-Cell Non-Hodgkin's Lymphoma

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • PET and CT (w/oral and IV contrast) 90 days after treatment

Secondary Outcome Measures:
  • possible diagnostic needle core biopsy

Estimated Enrollment: 12
Study Start Date: December 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • B-cell non-Hodgkin’s lymphoma of one of the following types as defined by the WHO classification:
  • Small lymphocytic lymphoma/Chronic lymphocytic leukemia
  • Nodal marginal zone B-cell lymphoma
  • Extranodal marginal zone B-cell lymphoma
  • Splenic marginal zone lymphoma
  • Lymphoplasmacytic lymphoma
  • Follicular lymphoma
  • Diffuse large B-cell lymphoma which has transformed from one of the previously listed types of lymphomas
  • At least one site of lymphoma greater than or equal to 5 cm in any dimension
  • Received at least one prior therapy
  • Should show evidence of symptomatology as a result of their disease and/or evidence of progression of their disease.
  • Measurable disease using Cheson criteria [23] for Non-Hodgkin’s Lymphoma: a lymph node that is greater than 1 cm in its longest transverse diameter by CT scan should be considered compatible with involvement by NHL
  • No anti-cancer therapy for four weeks (six weeks if rituximab, nitrosourea or Mitomycin C) prior to study initiation, and fully recovered from all toxicities associated with prior surgery, radiation treatments, chemotherapy, or immunotherapy
  • An IRB-approved signed informed consent
  • Age greater than or equal to 18
  • Expected survival greater than or equal to 3 months
  • Prestudy performance status of 0, 1, or 2 according to WHO
  • Absolute neutrophil count ([segmented neutrophils + bands] x total WBC) > 1500/mm3 within two weeks prior to first dose of external beam radiation and also documented again two weeks prior to 90Y-ibritumomab tiuxetan treatment
  • Platelet counts greater than or equal to 100,000 within two weeks prior to first dose of external beam radiation and also documented again two weeks prior to 90Y-ibritumomab tiuxetan treatment
  • Bone marrow involvement by NHL less than 26% within six weeks of treatment with 90Y-ibritumomab tiuxetan
  • Cellularity of bone marrow > 15% within 6 weeks of study
  • Female patients who are not pregnant or lactating
  • Men and women of reproductive potential who are following accepted birth control methods (as determined by the treating physician, abstinence is an acceptable method)

Exclusion Criteria:

  • Prior radioimmunotherapy
  • Presence of CNS lymphoma
  • Absolute lymphocyte count ≥ 5000
  • HIV or AIDS-related lymphoma
  • Large pleural effusions or ascites
  • Total bilirubin > 2.0 mg/dL
  • Serum creatinine > 2.0 mg/dL
  • Patients who, in the opinion of their oncology team, have prior external beam radiation therapy to > 25% of active skeletal marrow (either involved field or regional)
  • Patients who have received G-CSF or GM-CSF therapy within two weeks or pegfilgrastim within 4 weeks prior to treatment
  • Serious nonmalignant disease or infection which, in the opinion of the investigator, would compromise other protocol objectives
  • Major surgery, other than diagnostic surgery, within four weeks
  • Pregnant women or women of child-bearing age who refuse pregnancy tests
  • Patients who have had prior myeloablative autologous or allogenic stem cell transplantation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00271050

Contacts
Contact: Roger Macklis, MD 216-444-5576 macklir@ccf.org
Contact: Ruth Cocirteu, RN 216-445-5053 cocirtr@ccf.org

Locations
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Roger Macklis, MD Cleveland Clinic
  More Information

Publications:
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Seymour JF. New treatment approaches to indolent non-Hodgkin's lymphoma. Semin Oncol. 2004 Feb;31(1 Suppl 2):27-32. Review.
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Witzig TE, Gordon LI, Cabanillas F, Czuczman MS, Emmanouilides C, Joyce R, Pohlman BL, Bartlett NL, Wiseman GA, Padre N, Grillo-Lopez AJ, Multani P, White CA. Randomized controlled trial of yttrium-90-labeled ibritumomab tiuxetan radioimmunotherapy versus rituximab immunotherapy for patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma. J Clin Oncol. 2002 May 15;20(10):2453-63.
Justice TE, Martenson JA, Wiseman GA, Witzig TE. External beam radiation therapy after 90Y-ibritumomab tiuxetan radioimmunotherapy for relapsed or refractory CD20+ non-Hodgkin's lymphoma. Int J Radiat Oncol Biol Phys 2003; 57(Suppl 2):S287-8
O'Doherty MJ, Hoskin PJ. Positron emission tomography in the management of lymphomas: a summary. Eur J Nucl Med Mol Imaging. 2003 Jun;30 Suppl 1:S128-30. Epub 2003 Apr 12. Review. No abstract available.
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Study ID Numbers: IRB 7883, CCF IRB 7883, Case 1405
Study First Received: December 28, 2005
Last Updated: December 28, 2005
ClinicalTrials.gov Identifier: NCT00271050  
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
non-Hodgkin's lymphoma
external beam radiotherapy (EBRT)
radio-immunotherapy (RIT)
Zevalin

Study placed in the following topic categories:
Lymphoma, B-Cell
Lymphatic Diseases
Immunoproliferative Disorders
B-cell lymphomas
Lymphoma, small cleaved-cell, diffuse
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009