Non Hodgkin Lymphoma Clinical Trial

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

Summary

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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

84

Study ID:

NCT00062114

Recruitment Status:

Completed

Sponsor:

Alliance for Clinical Trials in Oncology

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There are 80 Locations for this study

See Locations Near You

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
Providence Saint Joseph Medical Center - Burbank
Burbank California, 91505, United States
Moores UCSD Cancer Center
La Jolla California, 92093, United States
Kaiser Permanente Medical Office -Vandever Medical Office
San Diego California, 92120, United States
Beebe Medical Center
Lewes Delaware, 19958, United States
CCOP - Christiana Care Health Services
Newark Delaware, 19713, United States
Rush-Copley Cancer Care Center
Aurora Illinois, 60507, United States
University of Illinois Cancer Center
Chicago Illinois, 60612, United States
University of Chicago Cancer Research Center
Chicago Illinois, 60637, United States
Joliet Oncology-Hematology Associates, Limited - West
Joliet Illinois, 60435, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana Illinois, 61801, United States
CCOP - Carle Cancer Center
Urbana Illinois, 61801, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove Indiana, 46107, United States
Saint Anthony Memorial Health Centers
Michigan City Indiana, 46360, United States
Reid Hospital & Health Care Services, Incorporated
Richmond Indiana, 47374, United States
Tammy Walker Cancer Center at Salina Regional Health Center
Salina Kansas, 67401, United States
Cotton-O'Neil Cancer Center
Topeka Kansas, 66604, United States
St. Francis Comprehensive Cancer Center
Topeka Kansas, 66606, United States
Central Maine Comprehensive Cancer Center at Central Maine Medical Center
Lewiston Maine, 04240, United States
Union Hospital Cancer Program at Union Hospital
Elkton MD Maryland, 21921, United States
Dana-Farber/Brigham and Women's Cancer Center
Boston Massachusetts, 02115, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston Massachusetts, 02115, United States
Cancer Research Center at Boston Medical Center
Boston Massachusetts, 02118, United States
Borgess Medical Center
Kalamazooaa Michigan, 49001, United States
West Michigan Cancer Center
Kalamazoo Michigan, 49007, United States
Bronson Methodist Hospital
Kalamazoo Michigan, 49007, United States
CCOP - Cancer Research for the Ozarks
Springfield Missouri, 65802, United States
St. John's Regional Health Center
Springfield Missouri, 65804, United States
Hulston Cancer Center at Cox Medical Center South
Springfield Missouri, 65807, United States
CCOP - Montana Cancer Consortium
Billings Montana, 59101, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings Montana, 59101, United States
Northern Rockies Radiation Oncology Center
Billings Montana, 59101, United States
St. Vincent Healthcare Cancer Care Services
Billings Montana, 59101, United States
Billings Clinic Cancer Center
Billings Montana, 59107, United States
Billings Clinic - Downtown
Billings Montana, 59107, United States
Bozeman Deaconess Cancer Center
Bozeman Montana, 59715, United States
St. James Healthcare Cancer Care
Butte Montana, 59701, United States
Great Falls Clinic - Main Facility
Great Falls Montana, 59405, United States

Great Falls Montana, 59405, United States
St. Peter's Hospital
Helena Montana, 59601, United States
Glacier Oncology, PLLC
Kalispell Montana, 59901, United States
Kalispell Medical Oncology at KRMC
Kalispell Montana, 59901, United States
Kalispell Regional Medical Center
Kalispell Montana, 59901, United States
Community Medical Center
Missoula Montana, 59801, United States
Guardian Oncology and Center for Wellness
Missoula Montana, 59804, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula Montana, 59807, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula Montana, 59807, United States
Methodist Estabrook Cancer Center
Omaha Nebraska, 68114, United States
Kingsbury Center for Cancer Care at Cheshire Medical Center
Keene New Hampshire, 03431, United States
Norris Cotton Cancer Center at Dartmouth - Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States
Frisbie Memorial Hospital
Rochester New Hampshire, 03867, United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees New Jersey, 08043, United States
Our Lady of Mercy Medical Center Comprehensive Cancer Center
Bronx New York, 10466, United States
Charles R. Wood Cancer Center at Glens Falls Hospital
Glens Falls New York, 12801, United States
New York Weill Cornell Cancer Center at Cornell University
New York New York, 10021, United States
Stony Brook University Cancer Center
Stony Brook New York, 11794, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill North Carolina, 27599, United States
Wayne Memorial Hospital, Incorporated
Goldsboro North Carolina, 27534, United States
Wayne Radiation Oncology
Goldsboro North Carolina, 27534, United States
Rutherford Hospital
Rutherfordton North Carolina, 28139, United States
Wilson Medical Center
Wilson North Carolina, 27893, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem North Carolina, 27157, United States
Case Comprehensive Cancer Center
Cleveland Ohio, 44106, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus Ohio, 43210, United States
Grandview Hospital
Dayton Ohio, 45405, United States
Good Samaritan Hospital
Dayton Ohio, 45406, United States
David L. Rike Cancer Center at Miami Valley Hospital
Dayton Ohio, 45409, United States
Samaritan North Cancer Care Center
Dayton Ohio, 45415, United States
Veterans Affairs Medical Center - Dayton
Dayton Ohio, 45428, United States
CCOP - Dayton
Dayton Ohio, 45429, United States
Blanchard Valley Medical Associates
Findlay Ohio, 45840, United States
Charles F. Kettering Memorial Hospital
Kettering Ohio, 45429, United States
Middletown Regional Hospital
Middletown Ohio, 45044, United States
UVMC Cancer Care Center at Upper Valley Medical Center
Troy Ohio, 45373, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia Ohio, 45385, United States
St. Luke's Cancer Network at St. Luke's Hospital
Bethlehem Pennsylvania, 18015, United States
AnMed Cancer Center
Anderson South Carolina, 29621, United States
CCOP - Upstate Carolina
Spartanburg South Carolina, 29303, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg South Carolina, 29303, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls South Dakota, 57117, United States
CCOP - Scott and White Hospital
Temple Texas, 76508, United States
American Fork Hospital
American Fork Utah, 84003, United States
Logan Regional Hospital
Logan Utah, 84321, United States
Cottonwood Hospital Medical Center
Murray Utah, 84107, United States
McKay-Dee Hospital Center
Ogden Utah, 84403, United States
Utah Valley Regional Medical Center - Provo
Provo Utah, 84604, United States
Dixie Regional Medical Center - East Campus
Saint George Utah, 84770, United States
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City Utah, 84106, United States
Latter Day Saints Hospital
Salt Lake City Utah, 84143, United States
Mountainview Medical
Berlin Vermont, 05602, United States
Fletcher Allen Health Care - University Health Center Campus
Burlington Vermont, 05401, United States
Virginia Commonwealth University Massey Cancer Center
Richmond Virginia, 23298, United States
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan Wyoming, 82801, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

84

Study ID:

NCT00062114

Recruitment Status:

Completed

Sponsor:


Alliance for Clinical Trials in Oncology

How clear is this clinincal trial information?

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