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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate

Safety Issue:

No

Principal Investigator

Thomas C. Shea, MD

Investigator Role:

Study Chair

Investigator Affiliation:

UNC Lineberger Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000304498

NCT ID:

NCT00062114

Start Date:

April 2004

Completion Date:

Related Keywords:

  • Lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Carle Cancer CenterUrbana, Illinois  61801
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Joliet Oncology-Hematology Associates, Limited - WestJoliet, Illinois  60435
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Avera Cancer InstituteSioux Falls, South Dakota  57105
Providence Saint Joseph Medical Center - BurbankBurbank, California  91505
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
CCOP - DaytonKettering, Ohio  45429
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State UniversityColumbus, Ohio  43210-1240
CCOP - Scott and White HospitalTemple, Texas  76508
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Cancer Research Center at Boston Medical CenterBoston, Massachusetts  02118
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
Sioux Valley Hospital and University of South Dakota Medical CenterSioux Falls, South Dakota  57117-5134
Latter Day Saints HospitalSalt Lake City, Utah  84143
Stony Brook University Cancer CenterStony Brook, New York  11794-8174
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Our Lady of Mercy Medical Center Comprehensive Cancer CenterBronx, New York  10466
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
St. Peter's HospitalHelena, Montana  59601
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Community Medical CenterMissoula, Montana  59801
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
American Fork HospitalAmerican Fork, Utah  84003
Logan Regional HospitalLogan, Utah  84321
Cottonwood Hospital Medical CenterMurray, Utah  84107
McKay-Dee Hospital CenterOgden, Utah  84403
Utah Cancer Specialists at UCS Cancer CenterSalt Lake City, Utah  84106
New York Weill Cornell Cancer Center at Cornell UniversityNew York, New York  10021
University of Illinois Cancer CenterChicago, Illinois  60612-7243
Virginia Commonwealth University Massey Cancer CenterRichmond, Virginia  23298-0037
Methodist Estabrook Cancer CenterOmaha, Nebraska  68114-4199
Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Kaiser Permanente Medical Office -Vandever Medical OfficeSan Diego, California  92120
Beebe Medical CenterLewes, Delaware  19958
St. Francis Hospital and Health Centers - Beech Grove CampusBeech Grove, Indiana  46107
Reid Hospital & Health Care Services, IncorporatedRichmond, Indiana  47374
St. Francis Comprehensive Cancer CenterTopeka, Kansas  66606
Kingsbury Center for Cancer Care at Cheshire Medical CenterKeene, New Hampshire  03431
Frisbie Memorial HospitalRochester, New Hampshire  03867
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Charles R. Wood Cancer Center at Glens Falls HospitalGlens Falls, New York  12801
Wayne Radiation OncologyGoldsboro, North Carolina  27534
Wilson Medical CenterWilson, North Carolina  27893-3428
Samaritan North Cancer Care CenterDayton, Ohio  45415
Grandview HospitalDayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Good Samaritan HospitalDayton, Ohio  45406
Blanchard Valley Medical AssociatesFindlay, Ohio  45840
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Middletown Regional HospitalMiddletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Dixie Regional Medical Center - East CampusSaint George, Utah  84770
Mountainview MedicalBerlin, Vermont  05602
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
Tammy Walker Cancer Center at Salina Regional Health CenterSalina, Kansas  67401
Cotton-O'Neil Cancer CenterTopeka, Kansas  66606
Union Hospital Cancer Program at Union HospitalElkton MD, Maryland  21921
Billings Clinic - DowntownBillings, Montana  59107-7000
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
St. James Healthcare Cancer CareButte, Montana  59701
Great Falls Clinic - Main FacilityGreat Falls, Montana  59405
Kalispell Medical Oncology at KRMCKalispell, Montana  59901
St. Luke's Cancer Network at St. Luke's HospitalBethlehem, Pennsylvania  18015
Rutherford HospitalRutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Dana-Farber/Brigham and Women's Cancer CenterBoston, Massachusetts  02115
Billings Clinic Cancer CenterBillings, Montana  59107-5100
Great Falls, Montana  59405
Guardian Oncology and Center for WellnessMissoula, Montana  59804
Norris Cotton Cancer Center at Dartmouth - Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
St. Vincent Healthcare Cancer Care ServicesBillings, Montana  59101
AnMed Cancer CenterAnderson, South Carolina  29621
Central Maine Comprehensive Cancer Center at Central Maine Medical CenterLewiston, Maine  04240