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

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00062114
• Other study ID #: CALGB-50201
• Secondary ID: CALGB-50201CDR00
• Status: Completed
• Phase: Phase 2
• First received: June 5, 2003
• Last updated: July 1, 2016
• Start date: April 2004
• Est. completion date: April 2007

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

Biological:
• rituximab

Radiation:
• yttrium Y 90 ibritumomab tiuxetan

Locations

Country	Name	City	State
United States	American Fork Hospital	American Fork	Utah
United States	AnMed Cancer Center	Anderson	South Carolina
United States	Rush-Copley Cancer Care Center	Aurora	Illinois
United States	St. Francis Hospital and Health Centers - Beech Grove Campus	Beech Grove	Indiana
United States	Mountainview Medical	Berlin	Vermont
United States	St. Luke's Cancer Network at St. Luke's Hospital	Bethlehem	Pennsylvania
United States	Billings Clinic - Downtown	Billings	Montana
United States	Billings Clinic Cancer Center	Billings	Montana
United States	CCOP - Montana Cancer Consortium	Billings	Montana
United States	Hematology-Oncology Centers of the Northern Rockies - Billings	Billings	Montana
United States	Northern Rockies Radiation Oncology Center	Billings	Montana
United States	St. Vincent Healthcare Cancer Care Services	Billings	Montana
United States	Cancer Research Center at Boston Medical Center	Boston	Massachusetts
United States	Dana-Farber/Brigham and Women's Cancer Center	Boston	Massachusetts
United States	Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute	Boston	Massachusetts
United States	Bozeman Deaconess Cancer Center	Bozeman	Montana
United States	Our Lady of Mercy Medical Center Comprehensive Cancer Center	Bronx	New York
United States	Providence Saint Joseph Medical Center - Burbank	Burbank	California
United States	Fletcher Allen Health Care - University Health Center Campus	Burlington	Vermont
United States	St. James Healthcare Cancer Care	Butte	Montana
United States	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	University of Illinois Cancer Center	Chicago	Illinois
United States	Case Comprehensive Cancer Center	Cleveland	Ohio
United States	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University	Columbus	Ohio
United States	CCOP - Dayton	Dayton	Ohio
United States	David L. Rike Cancer Center at Miami Valley Hospital	Dayton	Ohio
United States	Good Samaritan Hospital	Dayton	Ohio
United States	Grandview Hospital	Dayton	Ohio
United States	Samaritan North Cancer Care Center	Dayton	Ohio
United States	Veterans Affairs Medical Center - Dayton	Dayton	Ohio
United States	Union Hospital Cancer Program at Union Hospital	Elkton MD	Maryland
United States	Blanchard Valley Medical Associates	Findlay	Ohio
United States	Charles R. Wood Cancer Center at Glens Falls Hospital	Glens Falls	New York
United States	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina
United States	Wayne Radiation Oncology	Goldsboro	North Carolina
United States	Great Falls Clinic - Main Facility	Great Falls	Montana
United States	St. Peter's Hospital	Helena	Montana
United States	Joliet Oncology-Hematology Associates, Limited - West	Joliet	Illinois
United States	Bronson Methodist Hospital	Kalamazoo	Michigan
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	Borgess Medical Center	Kalamazooaa	Michigan
United States	Glacier Oncology, PLLC	Kalispell	Montana
United States	Kalispell Medical Oncology at KRMC	Kalispell	Montana
United States	Kalispell Regional Medical Center	Kalispell	Montana
United States	Kingsbury Center for Cancer Care at Cheshire Medical Center	Keene	New Hampshire
United States	Charles F. Kettering Memorial Hospital	Kettering	Ohio
United States	Moores UCSD Cancer Center	La Jolla	California
United States	Norris Cotton Cancer Center at Dartmouth - Hitchcock Medical Center	Lebanon	New Hampshire
United States	Beebe Medical Center	Lewes	Delaware
United States	Central Maine Comprehensive Cancer Center at Central Maine Medical Center	Lewiston	Maine
United States	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Logan Regional Hospital	Logan	Utah
United States	Saint Anthony Memorial Health Centers	Michigan City	Indiana
United States	Middletown Regional Hospital	Middletown	Ohio
United States	Community Medical Center	Missoula	Montana
United States	Guardian Oncology and Center for Wellness	Missoula	Montana
United States	Montana Cancer Center at St. Patrick Hospital and Health Sciences Center	Missoula	Montana
United States	Montana Cancer Specialists at Montana Cancer Center	Missoula	Montana
United States	Cottonwood Hospital Medical Center	Murray	Utah
United States	New York Weill Cornell Cancer Center at Cornell University	New York	New York
United States	CCOP - Christiana Care Health Services	Newark	Delaware
United States	McKay-Dee Hospital Center	Ogden	Utah
United States	Methodist Estabrook Cancer Center	Omaha	Nebraska
United States	Utah Valley Regional Medical Center - Provo	Provo	Utah
United States	Reid Hospital & Health Care Services, Incorporated	Richmond	Indiana
United States	Virginia Commonwealth University Massey Cancer Center	Richmond	Virginia
United States	Frisbie Memorial Hospital	Rochester	New Hampshire
United States	Rutherford Hospital	Rutherfordton	North Carolina
United States	Dixie Regional Medical Center - East Campus	Saint George	Utah
United States	Tammy Walker Cancer Center at Salina Regional Health Center	Salina	Kansas
United States	Latter Day Saints Hospital	Salt Lake City	Utah
United States	Utah Cancer Specialists at UCS Cancer Center	Salt Lake City	Utah
United States	Kaiser Permanente Medical Office -Vandever Medical Office	San Diego	California
United States	Welch Cancer Center at Sheridan Memorial Hospital	Sheridan	Wyoming
United States	Avera Cancer Institute	Sioux Falls	South Dakota
United States	Sioux Valley Hospital and University of South Dakota Medical Center	Sioux Falls	South Dakota
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina
United States	CCOP - Cancer Research for the Ozarks	Springfield	Missouri
United States	Hulston Cancer Center at Cox Medical Center South	Springfield	Missouri
United States	St. John's Regional Health Center	Springfield	Missouri
United States	Stony Brook University Cancer Center	Stony Brook	New York
United States	CCOP - Scott and White Hospital	Temple	Texas
United States	Cotton-O'Neil Cancer Center	Topeka	Kansas
United States	St. Francis Comprehensive Cancer Center	Topeka	Kansas
United States	UVMC Cancer Care Center at Upper Valley Medical Center	Troy	Ohio
United States	Carle Cancer Center at Carle Foundation Hospital	Urbana	Illinois
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	Cancer Institute of New Jersey at Cooper - Voorhees	Voorhees	New Jersey
United States	Wilson Medical Center	Wilson	North Carolina
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina
United States	Ruth G. McMillan Cancer Center at Greene Memorial Hospital	Xenia	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate		Up to 4 years	No
Primary	Duration of response		Up to 4 years	No
Secondary	Complete response (CR), unconfirmed CR, and partial response		Up to 4 years	No
Secondary	Event-free survival		Up to 4 years	No
Secondary	Time to progression		Up to 4 years	No
Secondary	Time to next lymphoma treatment		Up to 4 years	No