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

NCT00062114 | Completed Phase 2

• 2 other identifiers: CALGB-50201CDR0000304498
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 94

Brief 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.

Conditions

Lymphoma

Keywords

recurrent adult diffuse large cell lymphoma; recurrent adult diffuse mixed cell lymphoma; recurrent adult immunoblastic large cell lymphoma

Outcome Measures

Primary Outcomes (2)

• Overall response rate

  Up to 4 years

• Duration of response

  Up to 4 years

Secondary Outcomes (4)

• Complete response (CR), unconfirmed CR, and partial response

  Up to 4 years

• Event-free survival

  Up to 4 years

• Time to progression

  Up to 4 years

• Time to next lymphoma treatment

  Up to 4 years

Study Arms (1)

rituximab + yttrium Y 90 ibritumomab tiuxetan

EXPERIMENTAL

Patients receive rituximab IV followed within 4 hours by yttrium Y 90 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.

Biological: rituximab; Radiation: yttrium Y 90 ibritumomab tiuxetan

Interventions

rituximab BIOLOGICAL

rituximab + yttrium Y 90 ibritumomab tiuxetan

yttrium Y 90 ibritumomab tiuxetan RADIATION

rituximab + yttrium Y 90 ibritumomab tiuxetan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (94)

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Providence Saint Joseph Medical Center - Burbank

Burbank, California, 91505, United States

Location

Moores UCSD Cancer Center

La Jolla, California, 92093-0658, United States

Location

Kaiser Permanente Medical Office -Vandever Medical Office

San Diego, California, 92120, United States

Location

Beebe Medical Center

Lewes, Delaware, 19958, United States

Location

CCOP - Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

Rush-Copley Cancer Care Center

Aurora, Illinois, 60507, United States

Location

University of Illinois Cancer Center

Chicago, Illinois, 60612-7243, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Joliet Oncology-Hematology Associates, Limited - West

Joliet, Illinois, 60435, United States

Location

Carle Cancer Center at Carle Foundation Hospital

Urbana, Illinois, 61801, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

St. Francis Hospital and Health Centers - Beech Grove Campus

Beech Grove, Indiana, 46107, United States

Location

Saint Anthony Memorial Health Centers

Michigan City, Indiana, 46360, United States

Location

Reid Hospital & Health Care Services, Incorporated

Richmond, Indiana, 47374, United States

Location

Tammy Walker Cancer Center at Salina Regional Health Center

Salina, Kansas, 67401, United States

Location

Cotton-O'Neil Cancer Center

Topeka, Kansas, 66604, United States

Location

St. Francis Comprehensive Cancer Center

Topeka, Kansas, 66606, United States

Location

Central Maine Comprehensive Cancer Center at Central Maine Medical Center

Lewiston, Maine, 04240, United States

Location

Union Hospital Cancer Program at Union Hospital

Elkton MD, Maryland, 21921, United States

Location

Dana-Farber/Brigham and Women's Cancer Center

Boston, Massachusetts, 02115, United States

Location

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Cancer Research Center at Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007-3731, United States

Location

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States

Location

Borgess Medical Center

Kalamazooaa, Michigan, 49001, United States

Location

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, 65802, United States

Location

St. John's Regional Health Center

Springfield, Missouri, 65804, United States

Location

Hulston Cancer Center at Cox Medical Center South

Springfield, Missouri, 65807, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

Hematology-Oncology Centers of the Northern Rockies - Billings

Billings, Montana, 59101, United States

Location

Northern Rockies Radiation Oncology Center

Billings, Montana, 59101, United States

Location

St. Vincent Healthcare Cancer Care Services

Billings, Montana, 59101, United States

Location

Billings Clinic Cancer Center

Billings, Montana, 59107-5100, United States

Location

Billings Clinic - Downtown

Billings, Montana, 59107-7000, United States

Location

Bozeman Deaconess Cancer Center

Bozeman, Montana, 59715, United States

Location

St. James Healthcare Cancer Care

Butte, Montana, 59701, United States

Location

Great Falls Clinic - Main Facility

Great Falls, Montana, 59405, United States

Location

Unknown Facility

Great Falls, Montana, 59405, United States

Location

St. Peter's Hospital

Helena, Montana, 59601, United States

Location

Glacier Oncology, PLLC

Kalispell, Montana, 59901, United States

Location

Kalispell Medical Oncology at KRMC

Kalispell, Montana, 59901, United States

Location

Kalispell Regional Medical Center

Kalispell, Montana, 59901, United States

Location

Community Medical Center

Missoula, Montana, 59801, United States

Location

Guardian Oncology and Center for Wellness

Missoula, Montana, 59804, United States

Location

Montana Cancer Specialists at Montana Cancer Center

Missoula, Montana, 59807-7877, United States

Location

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

Missoula, Montana, 59807, United States

Location

Methodist Estabrook Cancer Center

Omaha, Nebraska, 68114, United States

Location

Kingsbury Center for Cancer Care at Cheshire Medical Center

Keene, New Hampshire, 03431, United States

Location

Norris Cotton Cancer Center at Dartmouth - Hitchcock Medical Center

Lebanon, New Hampshire, 03756-0002, United States

Location

Frisbie Memorial Hospital

Rochester, New Hampshire, 03867, United States

Location

Cancer Institute of New Jersey at Cooper - Voorhees

Voorhees Township, New Jersey, 08043, United States

Location

Charles R. Wood Cancer Center at Glens Falls Hospital

Glens Falls, New York, 12801, United States

Location

New York Weill Cornell Cancer Center at Cornell University

New York, New York, 10021, United States

Location

Stony Brook University Cancer Center

Stony Brook, New York, 11794-8174, United States

Location

Our Lady of Mercy Medical Center Comprehensive Cancer Center

The Bronx, New York, 10466, United States

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, 27534, United States

Location

Wayne Radiation Oncology

Goldsboro, North Carolina, 27534, United States

Location

Rutherford Hospital

Rutherfordton, North Carolina, 28139, United States

Location

Wilson Medical Center

Wilson, North Carolina, 27893-3428, United States

Location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

Columbus, Ohio, 43210-1240, United States

Location

Grandview Hospital

Dayton, Ohio, 45405, United States

Location

Good Samaritan Hospital

Dayton, Ohio, 45406, United States

Location

David L. Rike Cancer Center at Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

Samaritan North Cancer Care Center

Dayton, Ohio, 45415, United States

Location

Veterans Affairs Medical Center - Dayton

Dayton, Ohio, 45428, United States

Location

CCOP - Dayton

Dayton, Ohio, 45429, United States

Location

Blanchard Valley Medical Associates

Findlay, Ohio, 45840, United States

Location

Charles F. Kettering Memorial Hospital

Kettering, Ohio, 45429, United States

Location

Middletown Regional Hospital

Middletown, Ohio, 45044, United States

Location

UVMC Cancer Care Center at Upper Valley Medical Center

Troy, Ohio, 45373-1300, United States

Location

Ruth G. McMillan Cancer Center at Greene Memorial Hospital

Xenia, Ohio, 45385, United States

Location

St. Luke's Cancer Network at St. Luke's Hospital

Bethlehem, Pennsylvania, 18015, United States

Location

AnMed Cancer Center

Anderson, South Carolina, 29621, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

Location

Sioux Valley Hospital and University of South Dakota Medical Center

Sioux Falls, South Dakota, 57117-5039, United States

Location

CCOP - Scott and White Hospital

Temple, Texas, 76508, United States

Location

American Fork Hospital

American Fork, Utah, 84003, United States

Location

Logan Regional Hospital

Logan, Utah, 84321, United States

Location

Cottonwood Hospital Medical Center

Murray, Utah, 84107, United States

Location

McKay-Dee Hospital Center

Ogden, Utah, 84403, United States

Location

Utah Valley Regional Medical Center - Provo

Provo, Utah, 84604, United States

Location

Utah Cancer Specialists at UCS Cancer Center

Salt Lake City, Utah, 84106, United States

Location

Latter Day Saints Hospital

Salt Lake City, Utah, 84143, United States

Location

Dixie Regional Medical Center - East Campus

St. George, Utah, 84770, United States

Location

Mountainview Medical

Berlin Corners, Vermont, 05602, United States

Location

Fletcher Allen Health Care - University Health Center Campus

Burlington, Vermont, 05401, United States

Location

Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia, 23298-0037, United States

Location

Welch Cancer Center at Sheridan Memorial Hospital

Sheridan, Wyoming, 82801, United States

Location

MeSH Terms

Conditions

Lymphoma; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Non-Hodgkin; Lymphoma, Large-Cell, Immunoblastic

Interventions

Rituximab; ibritumomab tiuxetan

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Thomas C. Shea, MD

  UNC Lineberger Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2003
• First Posted: June 6, 2003
• Study Start: April 1, 2004
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: July 6, 2016

Record last verified: 2016-07

Locations

US (94)