or
forgot password

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 Center Seattle, Washington  98109
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood, Illinois  60153-5500
Cleveland Clinic Cancer Center Cleveland, Ohio  44195
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
CCOP - Atlanta Regional Atlanta, Georgia  30342-1701
CCOP - Montana Cancer Consortium Billings, Montana  59101
CCOP - Dayton Kettering, Ohio  45429
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
CCOP - St. Louis-Cape Girardeau Saint Louis, Missouri  63141
City of Hope Comprehensive Cancer Center Duarte, California  91010
Arizona Cancer Center at University of Arizona Health Sciences Center Tucson, Arizona  85724
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle, Washington  98104
Northside Hospital Cancer Center Atlanta, Georgia  30342-1611
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642
Alaska Regional Hospital Cancer Center Anchorage, Alaska  99508
Saint Anthony's Hospital at Saint Anthony's Health Center Alton, Illinois  62002
Good Samaritan Regional Health Center Mt. Vernon, Illinois  62864
David C. Pratt Cancer Center at St. John's Mercy St. Louis, Missouri  63141
Northern Rockies Radiation Oncology Center Billings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - Billings Billings, Montana  59101
Big Sky Oncology Great Falls, Montana  59405
St. Peter's Hospital Helena, Montana  59601
Kalispell Regional Medical Center Kalispell, Montana  59901
Glacier Oncology, PLLC Kalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula, Montana  59802
Montana Cancer Specialists at Montana Cancer Center Missoula, Montana  59802
Community Medical Center Missoula, Montana  59801
Olympic Hematology and Oncology Bremerton, Washington  98310
University Cancer Center at University of Washington Medical Center Seattle, Washington  98195
Harborview Medical Center Seattle, Washington  98104
Group Health Central Hospital Seattle, Washington  98104
Cancer Care Northwest - Spokane South Spokane, Washington  99202
Saint Joseph's Hospital of Atlanta Atlanta, Georgia  30342-1701
Piedmont Hospital Atlanta, Georgia  30309
WellStar Cobb Hospital Austell, Georgia  30106
Charles B. Eberhart Cancer Center at DeKalb Medical Center Decatur, Georgia  30033
Gwinnett Medical Center Lawrenceville, Georgia  30045
Kennestone Cancer Center at Wellstar Kennestone Hospital Marietta, Georgia  30060
Southern Regional Medical Center Riverdale, Georgia  30274-2600
St. Francis Hospital and Health Centers - Beech Grove Campus Beech Grove, Indiana  46107
Saint Francis Medical Center Cape Girardeau, Missouri  63701
Samaritan North Cancer Care Center Dayton, Ohio  45415
Grandview Hospital Dayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley Hospital Dayton, Ohio  45409
Good Samaritan Hospital Dayton, Ohio  45406
Blanchard Valley Medical Associates Findlay, Ohio  45840
Charles F. Kettering Memorial Hospital Kettering, Ohio  45429
Middletown Regional Hospital Middletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical Center Troy, Ohio  45373-1300
Cleveland Clinic - Wooster Wooster, Ohio  44691
Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia, Ohio  45385
Minor and James Medical, PLLC Seattle, Washington  98104
Polyclinic First Hill Seattle, Washington  98122
Welch Cancer Center at Sheridan Memorial Hospital Sheridan, Wyoming  82801
Harbin Clinic Cancer Center - Medical Oncology Rome, Georgia  30165
Reid Hospital & Health Care Services Richmond, Indiana  47374
Cotton-O'Neil Cancer Center Topeka, Kansas  66606
Billings Clinic - Downtown Billings, Montana  59107-7000
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
St. James Healthcare Cancer Care Butte, Montana  59701
Great Falls Clinic - Main Facility Great Falls, Montana  59405
Sletten Cancer Institute at Benefis Healthcare Great Falls, Montana  59405
Northern Montana Hospital Havre, Montana  59501
Kalispell Medical Oncology at KRMC Kalispell, Montana  59901
Wayne Hospital Greenville, Ohio  45331
Clinton Memorial Hospital Wilmington, Ohio  45177
St. Joseph Cancer Center Bellingham, Washington  98225
Evergreen Hematology and Oncology, PS Spokane, Washington  99218
Rocky Mountain Oncology Casper, Wyoming  82609
Rutherford Hospital Rutherfordton, North Carolina  28139
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Great Falls, Montana  59405
Guardian Oncology and Center for Wellness Missoula, Montana  59804
St. Vincent Healthcare Cancer Care Services Billings, Montana  59101
Midwest Hematology Oncology Group, Incorporated Saint Louis, Missouri  63109
AnMed Cancer Center Anderson, South Carolina  29621
Falck Cancer Center at Arnot Ogden Medical Center Elmira, New York  14905