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Phase II Study of Rituximab (NSC 687451) + CHOP Followed by 90Y-Ibritumomab Tiuxetan (NSC 710085) in Patients With Previously Untreated Mantle Cell Lymphoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

Thank you

Trial Information

Phase II Study of Rituximab (NSC 687451) + CHOP Followed by 90Y-Ibritumomab Tiuxetan (NSC 710085) in Patients With Previously Untreated Mantle Cell Lymphoma


OBJECTIVES:

- Determine the time to treatment failure in patients with previously untreated mantle
cell lymphoma treated with rituximab and CHOP chemotherapy comprising prednisone,
cyclophosphamide, doxorubicin, and vincristine followed by yttrium Y 90 ibritumomab
tiuxetan (IDEC-Y2B8; yttrium Y 90 ZevalinĀ®).

- Determine the response rate in patients at the completion of rituximab and CHOP and the
incremental response rate after IDEC-Y2B8.

- Determine the toxicity of this regimen in these patients.

- Correlate serum rituximab levels with response in patients treated with this regimen.

OUTLINE: This is a multicenter study.

- CHOP chemotherapy and rituximab: Patients receive cyclophosphamide IV, doxorubicin IV,
vincristine IV, and rituximab IV on day 1 and oral prednisone on days 1-5 (R + CHOP).
Treatment repeats every 21 days for 4 courses in the absence of disease progression or
unacceptable toxicity.

Patients who have responding or stable disease proceed to radioimmunotherapy.

- Radioimmunotherapy: Within 4-7 weeks after the completion of R + CHOP chemotherapy,
patients receive rituximab IV and an imaging dose of indium In 111 ibritumomab tiuxetan
IV over 10 minutes on day 1. Patients then undergo whole body gamma imaging scans
during the first day (2-24 hours) and the second or third day (48-72 hours) after
injection. In the absence of altered biodistribution, patients receive rituximab IV
followed by yttrium Y 90 ibritumomab tiuxetan (IDEC-Y2B8; yttrium Y 90 ZevalinĀ®) IV
over 10 minutes on day 8.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually for 5 years.

PROJECTED ACCRUAL: A total of 57 patients will be accrued for this study within 2.8 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed mantle cell lymphoma with expression of bcl-1 and CD20

- Stage II-IV disease

- Measurable or evaluable disease

- Measurable disease defined as at least 1 bidimensionally measurable lesion at
least 2 cm by imaging scan

- A spleen at least 17 cm or having discrete filling defects by CT scan will
constitute evaluable disease provided that no explanation other than
lymphomatous involvement (e.g., portal hypertension or other liver disease) is
likely

- No known CNS lymphoma

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- At least 6 months

Hematopoietic

- WBC greater than 2,500/mm^3*

- Platelet count greater than 100,000/mm^3* NOTE: *Unless due to disease in bone marrow

Hepatic

- Bilirubin less than 1.5 mg/dL (1.5-3.0 mg/dL if due to liver involvement by lymphoma)

- ALT and AST no greater than 2.5 times upper limit of normal (unless due to liver
involvement by lymphoma)

Renal

- Creatinine less than 2.0 mg/dL

- Calcium no greater than 11.5 mg/dL

Cardiovascular

- LVEF greater than 45%

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 1 year after study
participation

- HIV negative

- No other malignancy except treated carcinoma in situ of the cervix or squamous cell
or basal cell skin cancer or any other surgically cured malignancy from which the
patient has been disease-free for at least 3 years

- No other concurrent serious medical condition or active infection that would preclude
ability to deliver standard prednisone, cyclophosphamide, doxorubicin, and
vincristine (CHOP) chemotherapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior immunotherapy

Chemotherapy

- No prior chemotherapy

Endocrine therapy

- Prior corticosteroids allowed provided the course was no more than 2 weeks in
duration

Radiotherapy

- No prior radiotherapy

Surgery

- Not specified

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Mitchell R. Smith, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000334470

NCT ID:

NCT00070447

Start Date:

November 2003

Completion Date:

Related Keywords:

  • Lymphoma
  • contiguous stage II mantle cell lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • Lymphoma
  • Lymphoma, Mantle-Cell

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
Veterans Affairs Medical Center - Atlanta (Decatur)Decatur, Georgia  30033
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
Veterans Affairs Medical Center - Indianapolis (Roudebush)Indianapolis, Indiana  46202
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East OrangeEast Orange, New Jersey  07018-1095
CCOP - Northern New JerseyHackensack, New Jersey  07601
Hahnemann University HospitalPhiladelphia, Pennsylvania  19102-1192
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
CCOP - DuluthDuluth, Minnesota  55805
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
CCOP - OchsnerNew Orleans, Louisiana  70121
CCOP - Merit Care HospitalFargo, North Dakota  58122
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
CCOP - Central IllinoisSpringfield, Illinois  62526
CCOP - ColumbusColumbus, Ohio  43206
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
Veterans Affairs Medical Center - MadisonMadison, Wisconsin  53705
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Veterans Affairs Medical Center - Milwaukee (Zablocki)Milwaukee, Wisconsin  53295
CCOP - EvanstonEvanston, Illinois  60201
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Cancer Center at Tufts - New England Medical CenterBoston, Massachusetts  02111
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
MBCCOP - University of New Mexico HSCAlbuquerque, New Mexico  87131
MetroHealth's Cancer Care Center at MetroHealth Medical CenterCleveland, Ohio  44106
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical CenterNashville, Tennessee  37232-2516
CCOP - Scott and White HospitalTemple, Texas  76508
Veterans Affairs Medical Center - Lakeside ChicagoChicago, Illinois  60611
Veterans Affairs Medical Center - New YorkNew York, New York  10010
CCOP - St. Vincent Hospital Cancer Center, Green BayGreen Bay, Wisconsin  54301
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Veterans Affairs Medical Center - WichitaWichita, Kansas  67218
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
CCOP - OklahomaTulsa, Oklahoma  74136
Veterans Affairs Medical Center - PittsburghPittsburgh, Pennsylvania  15240
Veterans Affairs Medical Center - MiamiMiami, Florida  33125
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
Veterans Affairs Medical Center - Palo AltoPalo Alto, California  94304
City of Hope Comprehensive Cancer CenterDuarte, California  91010
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
Midlands Cancer Center at Midlands Community HospitalPapillion, Nebraska  68128-4157
CCOP - Colorado Cancer Research Program, IncorporatedDenver, Colorado  80224
Hillman Cancer Center at University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15236
Veterans Affairs Medical Center - BrooklynBrooklyn, New York  11209
Veterans Affairs Medical Center - Tampa (Haley)Tampa, Florida  33612
Stanford Cancer Center at Stanford University Medical CenterStanford, California  94305
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville CampusNashville, Tennessee  37212
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
Comprehensive Cancer Center at University of Alabama at BirminghamBirmingham, Alabama  35294
Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322
Albert Einstein Cancer Center at Albert Einstein College of MedicineBronx, New York  10461
NYU Cancer Institute at New York University Medical CenterNew York, New York  10016
CCOP - Marshfield Clinic Research FoundationMarshfield, Wisconsin  54449
MBCCOP - Howard University Cancer CenterWashington, District of Columbia  20060
Swedish-American Regional Cancer CenterRockford, Illinois  61104-2315
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903
MBCCOP-Our Lady of Mercy Cancer CenterBronx, New York  10466
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Veterans Affairs Medical Center - GainesvilleGainesville, Florida  32608-1197
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Burgess Health CenterOnawa, Iowa  51040
Veterans Affairs Medical Center - OmahaOmaha, Nebraska  68105
CCOP - Mayo Clinic Scottsdale Oncology ProgramScottsdale, Arizona  85259
H. Lee Moffitt Cancer Center and Research Institute at University of South FloridaTampa, Florida  33612