External Beam Radiotherapy and Zevalin for Management of Indolent B-Cell Non-Hodgkin's Lymphoma

This study has been completed.
Sponsor:
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00271050
First received: December 28, 2005
Last updated: December 20, 2010
Last verified: December 2010
  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
Other: external beam radiotherapy plus 90-Y ibritumomab tiuxetan
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • PET and CT (w/oral and IV contrast) [ Time Frame: 90 days after treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: December 2005
Study Completion Date: June 2010
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Other: external beam radiotherapy plus 90-Y ibritumomab tiuxetan
combination of EBRT followed by radioimmunotherapeutic 90-Y ibritumomab tiuxetan
Other Name: Zevalin

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00271050

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

Publications:
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
Scheidhauer K, Wolf I, von Schilling C, Rose C, Schmidt B, Schwarz K, Reidel G, Peschel C, Schwaiger M. Outcome prediction of radioimmunotherapy of NHL by FDG-PET. Eur J Nucl Med 2002; 29(Suppl 1):S113
Hofmann M, Hertenstein B, Boerner AR, Heil G, Peest D, Knoop BO, Geworski L, Otto D, Ganser A, Knapp WH. 18-F-FDG-PET in monitoring therapy response to RIT by 131-I Rituximab (Mabthera) antibody. Annals Onc 2002; 13 (Suppl 2): 96.
Macklis R, Molina A, Pohlman B, Gordon L, Wang H, Saville MW, Witzig T. Long-term responses in patients with relapsed or refractory follicular lymphoma treated with yttrium 90 ibritumomab tiuxetan (Zevalin). Int J Radiat Oncol Biol Phys 2004; 60 (Suppl 1): S542 (2346).

Responsible Party: Roger Macklis, MD, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00271050     History of Changes
Other Study ID Numbers: IRB 7883, CCF IRB 7883, Case 1405
Study First Received: December 28, 2005
Last Updated: December 20, 2010
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

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014