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

This study has been completed.
Sponsor:
Collaborators:
Southwest Oncology Group
Eastern Cooperative Oncology Group
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00062114
First received: June 5, 2003
Last updated: February 6, 2009
Last verified: April 2007
  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.

PURPOSE: This phase II trial is studying how well giving yttrium Y 90 ibritumomab tiuxetan together with rituximab works in treating patients with progressive non-Hodgkin's lymphoma.


Condition Intervention Phase
Lymphoma
Biological: rituximab
Radiation: yttrium Y 90 ibritumomab tiuxetan
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study To Evaluate The Safety And Efficacy Of Zevalin (IND # BB IND 4850) Therapeutic Regimen In Patients With Transformed CD20 + B-Cell Non-Hodgkin's Lymphoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Overall response rate [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complete response (CR), unconfirmed CR, and partial response [ Designated as safety issue: No ]
  • Event-free survival [ Designated as safety issue: No ]
  • Time to progression [ Designated as safety issue: No ]
  • Time to next lymphoma treatment [ Designated as safety issue: No ]

Estimated Enrollment: 84
Study Start Date: April 2004
Detailed Description:

OBJECTIVES:

  • Determine the efficacy of yttrium Y 90 ibritumomab tiuxetan and rituximab, in terms of overall response rate (complete, unconfirmed complete, and partial) and duration of response, in patients with transformed CD20+ B-cell non-Hodgkin's lymphoma.
  • Determine the safety of this regimen in these patients.
  • Determine the event-free survival and time to treatment progression in patients treated with this regimen.
  • Determine the immunogenicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive rituximab IV followed within 4 hours by indium In 111 ibritumomab tiuxetan IV (for imaging) over 10 minutes on day 1. Patients undergo 1 (or 2 if needed) imaging scan between days 2-5. In the absence of altered biodistribution, patients receive rituximab IV followed within 4 hours by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.

Patients are followed monthly for 3 months, every 3 months for 2 years, and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 84 patients will be accrued for this study within 18-24 months.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed transformed CD20+ B-cell non-Hodgkin's lymphoma (NHL)

    • Transformation defined as:

      • Progression to a more aggressive diffuse lymphoma, excluding conversion to a more aggressive grade of follicular lymphoma (e.g., WHO/REAL follicular center, large, grade III NHL)
    • Initial large cell follicular lymphoma must progress to a diffuse large cell lymphoma
    • De novo transformed NHL ineligible
  • Requiring treatment as determined by any of the following characteristics:

    • An increase in overall tumor size
    • Presence of B symptoms
    • Presence of masses that are causing ongoing clinical symptomatology
  • Must have less than 25% bone marrow involvement with lymphoma
  • Must have received and either relapsed or failed to respond to prior therapy for initial low grade or follicular NHL
  • Must have bidimensionally measurable disease defined as:

    • Greater than 2 cm OR 1.5 cm if 0.5 cm slices are used during spiral CT scan
    • Nonmeasurable disease includes any of the following:

      • Bone lesions
      • Leptomeningeal disease
      • Ascites
      • Pleural or pericardial effusion
      • Inflammatory breast disease
      • Lymphangitis cutis/pulmonis
      • Abdominal masses that are not confirmed and followed by imaging techniques
      • Cystic lesions
      • Lesions that are situated in a previously irradiated area
  • No expected impairment in bone marrrow reserve meeting any of the following criteria:

    • Platelet count less than 150,000/mm^3
    • Hypocellular bone marrow (less than 15% cellularity)
    • Marked reduction in bone marrow precursors of one or more cell lines (e.g., granulocytic, megakaryocytic, or erythroid)
    • History of failed stem cell collection
  • Patients with peritoneal invasion and/or ascites with positive cytology for lymphoma OR pleural invasion and/or effusion with positive cytology for lymphoma are eligible only if their effusion or ascites can be tapped dry

    • No significant remaining malignant effusion or ascites at the time of study drug administration
  • No known meningeal lymphoma or known parenchymal CNS 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

  • 18 and over

Performance status

  • 0-2

Life expectancy

  • Not specified

Hematopoietic

  • See Disease Characteristics
  • Absolute neutrophil count at least 1,500/mm^3
  • Lymphocyte count no greater than 5,000/mm^3
  • Platelet count at least 150,000/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 treatment
  • HIV negative
  • No other malignancy except nonmelanoma skin cancer unless patient has completed therapy and is considered to be at less than 30% risk of relapse
  • No human anti-mouse antibody (HAMA) reactivity (patients with prior exposure to murine antibodies)

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Radiotherapy
  • At least 3 weeks since prior anticancer immunotherapy (6 weeks for rituximab) and recovered
  • More than 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF)
  • No prior myeloablative therapy with bone marrow transplantation or peripheral blood stem cell rescue

Chemotherapy

  • See Biologic therapy
  • At least 3 weeks since prior anticancer chemotherapy (6 weeks for nitrosourea or mitomycin) and recovered

Endocrine therapy

  • No concurrent systemic corticosteroids with either of the following dose schedules:

    • No greater than 50 mg of prednisone as a single dose (or equivalent)
    • No greater than 50 mg of prednisone per dose (or equivalent) for more than 6 doses

Radiotherapy

  • See Disease Characteristics
  • At least 3 weeks since prior anticancer radiotherapy and recovered
  • No prior radioimmunotherapy, including yttrium Y 90 ibritumomab tiuxetan
  • No prior external beam radiotherapy to more than 25% of active bone marrow (involved field or regional)

Surgery

  • At least 3 weeks since prior anticancer surgery and recovered
  • More than 4 weeks since prior major surgery (other than diagnostic surgery)

Other

  • At least 3 weeks since other prior anticancer therapy and recovered
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00062114

  Hide Study Locations
Locations
United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States, 91505
Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0658
Kaiser Permanente Medical Office -Vandever Medical Office
San Diego, California, United States, 92120
United States, Delaware
Beebe Medical Center
Lewes, Delaware, United States, 19958
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, Illinois
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60507
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612-7243
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States, 60435
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States, 61801
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, United States, 46107
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States, 46360
Reid Hospital & Health Care Services, Incorporated
Richmond, Indiana, United States, 47374
United States, Kansas
Tammy Walker Cancer Center at Salina Regional Health Center
Salina, Kansas, United States, 67401
Cotton-O'Neil Cancer Center
Topeka, Kansas, United States, 66604
St. Francis Comprehensive Cancer Center
Topeka, Kansas, United States, 66606
United States, Maine
Central Maine Comprehensive Cancer Center at Central Maine Medical Center
Lewiston, Maine, United States, 04240
United States, Maryland
Union Hospital Cancer Program at Union Hospital
Elkton MD, Maryland, United States, 21921
United States, Massachusetts
Cancer Research Center at Boston Medical Center
Boston, Massachusetts, United States, 02118
Dana-Farber/Brigham and Women's Cancer Center
Boston, Massachusetts, United States, 02115
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Michigan
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
Borgess Medical Center
Kalamazooaa, Michigan, United States, 49001
United States, Missouri
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65802
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States, 65807
St. John's Regional Health Center
Springfield, Missouri, United States, 65804
United States, Montana
Billings Clinic - Downtown
Billings, Montana, United States, 59107-7000
Northern Rockies Radiation Oncology Center
Billings, Montana, United States, 59101
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States, 59101
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
St. Vincent Healthcare Cancer Care Services
Billings, Montana, United States, 59101
Billings Clinic Cancer Center
Billings, Montana, United States, 59107-5100
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States, 59715
St. James Healthcare Cancer Care
Butte, Montana, United States, 59701
Great Falls Clinic - Main Facility
Great Falls, Montana, United States, 59405
Great Falls, Montana, United States, 59405
St. Peter's Hospital
Helena, Montana, United States, 59601
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Glacier Oncology, PLLC
Kalispell, Montana, United States, 59901
Kalispell Medical Oncology at KRMC
Kalispell, Montana, United States, 59901
Community Medical Center
Missoula, Montana, United States, 59801
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States, 59807
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States, 59807-7877
Guardian Oncology and Center for Wellness
Missoula, Montana, United States, 59804
United States, Nebraska
Methodist Estabrook Cancer Center
Omaha, Nebraska, United States, 68114
United States, New Hampshire
Kingsbury Center for Cancer Care at Cheshire Medical Center
Keene, New Hampshire, United States, 03431
Norris Cotton Cancer Center at Dartmouth - Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
Frisbie Memorial Hospital
Rochester, New Hampshire, United States, 03867
United States, New Jersey
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees, New Jersey, United States, 08043
United States, New York
Our Lady of Mercy Medical Center Comprehensive Cancer Center
Bronx, New York, United States, 10466
Charles R. Wood Cancer Center at Glens Falls Hospital
Glens Falls, New York, United States, 12801
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States, 10021
Stony Brook University Cancer Center
Stony Brook, New York, United States, 11794-8174
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Wayne Radiation Oncology
Goldsboro, North Carolina, United States, 27534
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
Rutherford Hospital
Rutherfordton, North Carolina, United States, 28139
Wilson Medical Center
Wilson, North Carolina, United States, 27893-3428
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States, 43210-1240
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States, 45409
CCOP - Dayton
Dayton, Ohio, United States, 45429
Samaritan North Cancer Care Center
Dayton, Ohio, United States, 45415
Good Samaritan Hospital
Dayton, Ohio, United States, 45406
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States, 45428
Grandview Hospital
Dayton, Ohio, United States, 45405
Blanchard Valley Medical Associates
Findlay, Ohio, United States, 45840
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States, 45429
Middletown Regional Hospital
Middletown, Ohio, United States, 45044
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States, 45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States, 45385
United States, Pennsylvania
St. Luke's Cancer Network at St. Luke's Hospital
Bethlehem, Pennsylvania, United States, 18015
United States, South Carolina
AnMed Cancer Center
Anderson, South Carolina, United States, 29621
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
United States, Texas
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
United States, Utah
American Fork Hospital
American Fork, Utah, United States, 84003
Logan Regional Hospital
Logan, Utah, United States, 84321
Cottonwood Hospital Medical Center
Murray, Utah, United States, 84107
McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States, 84604
Dixie Regional Medical Center - East Campus
Saint George, Utah, United States, 84770
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City, Utah, United States, 84106
Latter Day Saints Hospital
Salt Lake City, Utah, United States, 84143
United States, Vermont
Mountainview Medical
Berlin, Vermont, United States, 05602
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States, 05401
United States, Virginia
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
United States, Wyoming
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming, United States, 82801
Sponsors and Collaborators
Cancer and Leukemia Group B
Southwest Oncology Group
Eastern Cooperative Oncology Group
Investigators
Study Chair: Thomas C. Shea, MD UNC Lineberger Comprehensive Cancer Center
Study Chair: Fay Young, MD James P. Wilmot Cancer Center
Study Chair: Andrew M. Evens, DO, MS Robert H. Lurie Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00062114     History of Changes
Other Study ID Numbers: CDR0000304498, CALGB-50201, SWOG-C50201, ECOG-C50201
Study First Received: June 5, 2003
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

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

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
Rituximab
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 17, 2014