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

Sponsor
Alliance for Clinical Trials in Oncology (Other)
Overall Status
Completed
CT.gov ID
NCT00062114
Collaborator
National Cancer Institute (NCI) (NIH)
84
Enrollment
94
Locations
1
Arm
36
Duration (Months)
0.9
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: rituximab
  • Radiation: yttrium Y 90 ibritumomab tiuxetan
 Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
84 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date :
Apr 1, 2004
Actual Primary Completion Date :
Apr 1, 2007
Actual Study Completion Date :
Apr 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: rituximab + yttrium Y 90 ibritumomab tiuxetan

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

Outcome Measures

Primary Outcome Measures

  1. Overall response rate [Up to 4 years]

  2. Duration of response [Up to 4 years]

Secondary Outcome Measures

  1. Complete response (CR), unconfirmed CR, and partial response [Up to 4 years]

  2. Event-free survival [Up to 4 years]

  3. Time to progression [Up to 4 years]

  4. Time to next lymphoma treatment [Up to 4 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
2 Providence Saint Joseph Medical Center - Burbank Burbank California United States 91505
3 Moores UCSD Cancer Center La Jolla California United States 92093-0658
4 Kaiser Permanente Medical Office -Vandever Medical Office San Diego California United States 92120
5 Beebe Medical Center Lewes Delaware United States 19958
6 CCOP - Christiana Care Health Services Newark Delaware United States 19713
7 Rush-Copley Cancer Care Center Aurora Illinois United States 60507
8 University of Illinois Cancer Center Chicago Illinois United States 60612-7243
9 University of Chicago Cancer Research Center Chicago Illinois United States 60637-1470
10 Joliet Oncology-Hematology Associates, Limited - West Joliet Illinois United States 60435
11 Carle Cancer Center at Carle Foundation Hospital Urbana Illinois United States 61801
12 CCOP - Carle Cancer Center Urbana Illinois United States 61801
13 St. Francis Hospital and Health Centers - Beech Grove Campus Beech Grove Indiana United States 46107
14 Saint Anthony Memorial Health Centers Michigan City Indiana United States 46360
15 Reid Hospital & Health Care Services, Incorporated Richmond Indiana United States 47374
16 Tammy Walker Cancer Center at Salina Regional Health Center Salina Kansas United States 67401
17 Cotton-O'Neil Cancer Center Topeka Kansas United States 66604
18 St. Francis Comprehensive Cancer Center Topeka Kansas United States 66606
19 Central Maine Comprehensive Cancer Center at Central Maine Medical Center Lewiston Maine United States 04240
20 Union Hospital Cancer Program at Union Hospital Elkton MD Maryland United States 21921
21 Dana-Farber/Brigham and Women's Cancer Center Boston Massachusetts United States 02115
22 Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute Boston Massachusetts United States 02115
23 Cancer Research Center at Boston Medical Center Boston Massachusetts United States 02118
24 Borgess Medical Center Kalamazooaa Michigan United States 49001
25 West Michigan Cancer Center Kalamazoo Michigan United States 49007-3731
26 Bronson Methodist Hospital Kalamazoo Michigan United States 49007
27 CCOP - Cancer Research for the Ozarks Springfield Missouri United States 65802
28 St. John's Regional Health Center Springfield Missouri United States 65804
29 Hulston Cancer Center at Cox Medical Center South Springfield Missouri United States 65807
30 CCOP - Montana Cancer Consortium Billings Montana United States 59101
31 Hematology-Oncology Centers of the Northern Rockies - Billings Billings Montana United States 59101
32 Northern Rockies Radiation Oncology Center Billings Montana United States 59101
33 St. Vincent Healthcare Cancer Care Services Billings Montana United States 59101
34 Billings Clinic Cancer Center Billings Montana United States 59107-5100
35 Billings Clinic - Downtown Billings Montana United States 59107-7000
36 Bozeman Deaconess Cancer Center Bozeman Montana United States 59715
37 St. James Healthcare Cancer Care Butte Montana United States 59701
38 Great Falls Clinic - Main Facility Great Falls Montana United States 59405
39 Great Falls Montana United States 59405
40 St. Peter's Hospital Helena Montana United States 59601
41 Glacier Oncology, PLLC Kalispell Montana United States 59901
42 Kalispell Medical Oncology at KRMC Kalispell Montana United States 59901
43 Kalispell Regional Medical Center Kalispell Montana United States 59901
44 Community Medical Center Missoula Montana United States 59801
45 Guardian Oncology and Center for Wellness Missoula Montana United States 59804
46 Montana Cancer Specialists at Montana Cancer Center Missoula Montana United States 59807-7877
47 Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula Montana United States 59807
48 Methodist Estabrook Cancer Center Omaha Nebraska United States 68114
49 Kingsbury Center for Cancer Care at Cheshire Medical Center Keene New Hampshire United States 03431
50 Norris Cotton Cancer Center at Dartmouth - Hitchcock Medical Center Lebanon New Hampshire United States 03756-0002
51 Frisbie Memorial Hospital Rochester New Hampshire United States 03867
52 Cancer Institute of New Jersey at Cooper - Voorhees Voorhees New Jersey United States 08043
53 Our Lady of Mercy Medical Center Comprehensive Cancer Center Bronx New York United States 10466
54 Charles R. Wood Cancer Center at Glens Falls Hospital Glens Falls New York United States 12801
55 New York Weill Cornell Cancer Center at Cornell University New York New York United States 10021
56 Stony Brook University Cancer Center Stony Brook New York United States 11794-8174
57 Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill North Carolina United States 27599-7295
58 Wayne Memorial Hospital, Incorporated Goldsboro North Carolina United States 27534
59 Wayne Radiation Oncology Goldsboro North Carolina United States 27534
60 Rutherford Hospital Rutherfordton North Carolina United States 28139
61 Wilson Medical Center Wilson North Carolina United States 27893-3428
62 Wake Forest University Comprehensive Cancer Center Winston-Salem North Carolina United States 27157-1096
63 Case Comprehensive Cancer Center Cleveland Ohio United States 44106
64 Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Columbus Ohio United States 43210-1240
65 Grandview Hospital Dayton Ohio United States 45405
66 Good Samaritan Hospital Dayton Ohio United States 45406
67 David L. Rike Cancer Center at Miami Valley Hospital Dayton Ohio United States 45409
68 Samaritan North Cancer Care Center Dayton Ohio United States 45415
69 Veterans Affairs Medical Center - Dayton Dayton Ohio United States 45428
70 CCOP - Dayton Dayton Ohio United States 45429
71 Blanchard Valley Medical Associates Findlay Ohio United States 45840
72 Charles F. Kettering Memorial Hospital Kettering Ohio United States 45429
73 Middletown Regional Hospital Middletown Ohio United States 45044
74 UVMC Cancer Care Center at Upper Valley Medical Center Troy Ohio United States 45373-1300
75 Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia Ohio United States 45385
76 St. Luke's Cancer Network at St. Luke's Hospital Bethlehem Pennsylvania United States 18015
77 AnMed Cancer Center Anderson South Carolina United States 29621
78 CCOP - Upstate Carolina Spartanburg South Carolina United States 29303
79 Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg South Carolina United States 29303
80 Avera Cancer Institute Sioux Falls South Dakota United States 57105
81 Sioux Valley Hospital and University of South Dakota Medical Center Sioux Falls South Dakota United States 57117-5039
82 CCOP - Scott and White Hospital Temple Texas United States 76508
83 American Fork Hospital American Fork Utah United States 84003
84 Logan Regional Hospital Logan Utah United States 84321
85 Cottonwood Hospital Medical Center Murray Utah United States 84107
86 McKay-Dee Hospital Center Ogden Utah United States 84403
87 Utah Valley Regional Medical Center - Provo Provo Utah United States 84604
88 Dixie Regional Medical Center - East Campus Saint George Utah United States 84770
89 Utah Cancer Specialists at UCS Cancer Center Salt Lake City Utah United States 84106
90 Latter Day Saints Hospital Salt Lake City Utah United States 84143
91 Mountainview Medical Berlin Vermont United States 05602
92 Fletcher Allen Health Care - University Health Center Campus Burlington Vermont United States 05401
93 Virginia Commonwealth University Massey Cancer Center Richmond Virginia United States 23298-0037
94 Welch Cancer Center at Sheridan Memorial Hospital Sheridan Wyoming United States 82801

Sponsors and Collaborators

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

Investigators

  • Study Chair: Thomas C. Shea, MD, UNC Lineberger Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00062114
Other Study ID Numbers:
  • CALGB-50201
  • CALGB-50201
  • CDR0000304498
First Posted:
Jun 6, 2003
Last Update Posted:
Jul 6, 2016
Last Verified:
Jul 1, 2016
Keywords provided by Alliance for Clinical Trials in Oncology
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
Rituximab

Study Results

No Results Posted as of Jul 6, 2016