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Iodine-131-Labeled Monoclonal Anti-B1 Antibody (I-131 Tositumomab) in Combination With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Rituximab Therapy for Patients ≥ Age 60 With Advanced Stage Diffuse Large B-Cell NHL: A Phase II Study


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

Thank you

Trial Information

Iodine-131-Labeled Monoclonal Anti-B1 Antibody (I-131 Tositumomab) in Combination With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Rituximab Therapy for Patients ≥ Age 60 With Advanced Stage Diffuse Large B-Cell NHL: A Phase II Study


OBJECTIVES:

- Determine the 2-year progression-free survival of older patients with previously
untreated bulky stage II or stage III or IV diffuse large B-cell non-Hodgkin's lymphoma
treated with iodine I 131 tositumomab in combination with rituximab, cyclophosphamide,
doxorubicin, vincristine, and prednisone.

- Determine the response rate (partial response, complete unconfirmed response, and
complete response) in patients treated with this regimen.

- Determine the 2-year progression-free survival and response rate (partial response,
complete unconfirmed response, and complete response) in BCL-2 positive patients
treated with this regimen.

OUTLINE: This is a multicenter study.

- Rituximab and chemotherapy: Patients receive R-CHOP comprising rituximab IV over 6
hours; cyclophosphamide IV over 15-45 minutes; doxorubicin IV over 5-20 minutes; and
vincristine IV over 5-15 minutes on day 1 and oral prednisone on days 1-5. Treatment
repeats every 21 days for up to 6 courses in the absence of disease progression or
unacceptable toxicity. Patients then undergo a restaging evaluation. Patients without
progressive disease receive CHOP chemotherapy comprising cyclophosphamide, doxorubicin,
vincristine, and prednisone as outlined above. Treatment with CHOP chemotherapy repeats
every 21 days for 2 courses.

- Radiolabeled monoclonal antibody therapy: Approximately 4-8 weeks after completion of
chemotherapy, patients receive tositumomab IV over 1 hour followed by a dosimetric dose
of iodine I 131 tositumomab IV over 20 minutes. Patients then undergo gamma scans over
a 1-week period in order to determine the correct treatment dose of iodine I 131
tositumomab. No more than 2 weeks after administration of the dosimetric dose, patients
receive tositumomab IV over 1 hour followed by a treatment dose of iodine I 131
tositumomab IV over 20 minutes.

After completion of study treatment, patients are followed periodically for up to 5 years.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 15 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of diffuse large B-cell non-Hodgkin's lymphoma, meeting 1 of the following
stage criteria:

- Bulky stage II disease

- Stage III disease

- Stage IV disease

- Confirmed CD20 antigen-positive disease

- Bidimensionally measurable disease

- Less than 20,000/mcL circulating lymphoid cells on WBC differential count

- Adequate sections AND a paraffin block OR ≥ 10 unstained sections from the original
diagnostic specimen available

- Needle aspiration or cytology are not considered adequate

- No clinical evidence of CNS involvement by lymphoma

- No prior diagnosis of indolent lymphoma

- No histologic transformation

PATIENT CHARACTERISTICS:

Performance status

- Zubrod 0-2

Life expectancy

- Not specified

Hematopoietic

- See Disease Characteristics

Hepatic

- Not specified

Renal

- Not specified

Cardiovascular

- Ejection fraction ≥ 45% by MUGA OR

- No significant abnormalities by echocardiogram

Pulmonary

- No requirement for continuous supplemental oxygen

Other

- Fertile patients must use effective contraception during and for 6 months after
completion of study treatment

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, stage I or II cancer in complete remission, or carcinoma
in situ of the cervix

- No known HIV positivity

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior antibody therapy for lymphoma

Chemotherapy

- No prior chemotherapy for lymphoma

Endocrine therapy

- Not specified

Radiotherapy

- No prior radiotherapy for lymphoma

Surgery

- No prior solid organ transplantation

Other

- Concurrent enrollment on protocol SWOG-8947 (lymphoma serum repository) or protocol
SWOG-8819 (lymphoma tissue repository) is encouraged

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival at 2 years

Safety Issue:

No

Principal Investigator

Jonathan W. Friedberg, MD

Investigator Role:

Study Chair

Investigator Affiliation:

James P. Wilmot Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000415955

NCT ID:

NCT00107380

Start Date:

November 2005

Completion Date:

Related Keywords:

  • Lymphoma
  • contiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
Cleveland Clinic Cancer CenterCleveland, Ohio  44195
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - DaytonKettering, Ohio  45429
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
City of Hope Comprehensive Cancer CenterDuarte, California  91010
Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, Arizona  85724
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Northside Hospital Cancer CenterAtlanta, Georgia  30342-1611
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Alaska Regional Hospital Cancer CenterAnchorage, Alaska  99508
Saint Anthony's Hospital at Saint Anthony's Health CenterAlton, Illinois  62002
Good Samaritan Regional Health CenterMt. Vernon, Illinois  62864
David C. Pratt Cancer Center at St. John's MercySt. Louis, Missouri  63141
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
Big Sky OncologyGreat Falls, Montana  59405
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
Olympic Hematology and OncologyBremerton, Washington  98310
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Harborview Medical CenterSeattle, Washington  98104
Group Health Central HospitalSeattle, Washington  98104
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Saint Joseph's Hospital of AtlantaAtlanta, Georgia  30342-1701
Piedmont HospitalAtlanta, Georgia  30309
WellStar Cobb HospitalAustell, Georgia  30106
Charles B. Eberhart Cancer Center at DeKalb Medical CenterDecatur, Georgia  30033
Gwinnett Medical CenterLawrenceville, Georgia  30045
Kennestone Cancer Center at Wellstar Kennestone HospitalMarietta, Georgia  30060
Southern Regional Medical CenterRiverdale, Georgia  30274-2600
St. Francis Hospital and Health Centers - Beech Grove CampusBeech Grove, Indiana  46107
Saint Francis Medical CenterCape Girardeau, Missouri  63701
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
Cleveland Clinic - WoosterWooster, Ohio  44691
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Minor and James Medical, PLLCSeattle, Washington  98104
Polyclinic First HillSeattle, Washington  98122
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
Harbin Clinic Cancer Center - Medical OncologyRome, Georgia  30165
Reid Hospital & Health Care ServicesRichmond, Indiana  47374
Cotton-O'Neil Cancer CenterTopeka, Kansas  66606
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
Sletten Cancer Institute at Benefis HealthcareGreat Falls, Montana  59405
Northern Montana HospitalHavre, Montana  59501
Kalispell Medical Oncology at KRMCKalispell, Montana  59901
Wayne HospitalGreenville, Ohio  45331
Clinton Memorial HospitalWilmington, Ohio  45177
St. Joseph Cancer CenterBellingham, Washington  98225
Evergreen Hematology and Oncology, PSSpokane, Washington  99218
Rocky Mountain OncologyCasper, Wyoming  82609
Rutherford HospitalRutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Great Falls, Montana  59405
Guardian Oncology and Center for WellnessMissoula, Montana  59804
St. Vincent Healthcare Cancer Care ServicesBillings, Montana  59101
Midwest Hematology Oncology Group, IncorporatedSaint Louis, Missouri  63109
AnMed Cancer CenterAnderson, South Carolina  29621
Falck Cancer Center at Arnot Ogden Medical CenterElmira, New York  14905