Evaluation of CHOP Plus Involved Field Radiotherapy Followed by Yttrium-90 Ibritumomab Tiuxetan for Stages I, IE, and Non-Bulky Stages II and IIE, CD20 Positive, High-Risk Localized, Aggressive Histologies of Non-Hodgkin Lymphoma, Phase II
18 Years
N/A
Both
Lymphoma
Trial Information
Evaluation of CHOP Plus Involved Field Radiotherapy Followed by Yttrium-90 Ibritumomab Tiuxetan for Stages I, IE, and Non-Bulky Stages II and IIE, CD20 Positive, High-Risk Localized, Aggressive Histologies of Non-Hodgkin Lymphoma, Phase II
OBJECTIVES:
- Determine the 2-year progression-free survival of patients with aggressive high-risk
stage I or IE or non-bulky stage II or IIE CD20-positive non-Hodgkin's lymphoma treated
with cyclophosphamide, doxorubicin, vincristine, and prednisone and radiotherapy
followed by rituximab and yttrium Y 90 ibritumomab tiuxetan.
- Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
- Chemotherapy: Patients receive CHOP chemotherapy comprising cyclophosphamide IV over
1-2 hours, doxorubicin IV, and vincristine IV on day 1 and oral prednisone on days 1-5.
Treatment repeats every 21 days for 3 courses in the absence of disease progression or
unacceptable toxicity.
- Radiotherapy: Beginning 3 weeks after the completion of CHOP chemotherapy, patients
undergo radiotherapy once daily 5 days a week for 4-5 weeks.
- Monoclonal antibody therapy: Beginning 3-6 weeks after the completion of radiotherapy,
patients receive rituximab IV followed by indium In 111 ibritumomab tiuxetan IV over 10
minutes on day 1. Patients then undergo whole body imaging. If ibritumomab tiuxetan
biodistribution is acceptable, patients receive rituximab IV and yttrium Y 90
ibritumomab tiuxetan IV over 10 minutes on day 7, 8, OR 9.
Patients are followed every 6 months for 2 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 15 months.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed aggressive non-Hodgkin's lymphoma of 1 of the following
subtypes:
- Diffuse large B-cell
- Mantle cell
- High-grade B-cell, Burkitt's, or Burkitt-like
- Anaplastic large cell (B-cell phenotype only)
- Stage I, IE, or non-bulky* stage II or IIE disease by Ann Arbor classification
- Patients who have bulky stage II or IIE disease are ineligible even if, after
resection, the measurements are less than 10.0 cm NOTE: *Non-bulky disease
defined as any tumor measuring less than 10.0 cm or occupying less than 1/3 of
the chest diameter
- CD20-expressing disease by flow cytometry or immunoperoxidase staining
- Aggressive lymphomas must have at least 1 of the following adverse prognostic
factors:
- Non-bulky stage II or IIE disease
- At least 60 years of age
- Zubrod performance status of 2
- Lactic dehydrogenase greater than upper limit of normal
- All disease must be encompassable in a single radiation port (including any site of
resected disease) 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
- Over 18
Performance status
- Zubrod 0-2
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix
- No medical contraindication to study chemotherapy, rituximab, or ibritumomab tiuxetan
- No known AIDS syndrome or HIV-associated complex
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior monoclonal antibody therapy
Chemotherapy
- No prior chemotherapy for lymphoma
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- No prior radiotherapy for lymphoma
- No concurrent intensity-modulated radiotherapy
- Planned involved-field radiotherapy must not encompass more than 25% of active bone
marrow space
Surgery
- See Disease Characteristics
Other
- Concurrent participation in SWOG-8947 or SWOG-8819 allowed
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free Survival
Outcome Description:
PFS rate at 2 years
Outcome Time Frame:
at 6 weeks after treatment, then every 6 months for 2 years, then annually thereafter
Safety Issue:
No
Principal Investigator
Thomas P. Miller, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Arizona
Authority:
United States: Federal Government
Study ID:
CDR0000329864
NCT ID:
NCT00070018
Start Date:
February 2004
Completion Date:
November 2018
Related Keywords:
- Lymphoma
- stage I mantle cell lymphoma
- stage I adult diffuse large cell lymphoma
- stage I adult Burkitt lymphoma
- anaplastic large cell lymphoma
- contiguous stage II adult diffuse large cell lymphoma
- contiguous stage II adult Burkitt lymphoma
- contiguous stage II mantle cell lymphoma
- noncontiguous stage II adult diffuse large cell lymphoma
- noncontiguous stage II adult Burkitt lymphoma
- noncontiguous stage II mantle cell lymphoma
- Lymphoma
- Lymphoma, Non-Hodgkin
Name | Location |
|---|---|
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | Maywood, Illinois 60153-5500 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| Providence Saint Joseph Medical Center - Burbank | Burbank, California 91505 |
| CCOP - Greenville | Greenville, South Carolina 29615 |
| CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
| Charles M. Barrett Cancer Center at University Hospital | Cincinnati, Ohio 45267-0526 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| Wesley Medical Center | Wichita, Kansas 67214 |
| Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington 98104 |
| McDowell Cancer Center at Akron General Medical Center | Akron, Ohio 44307 |
| Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
| Alaska Regional Hospital Cancer Center | Anchorage, Alaska 99508 |
| Southwest Medical Center | Liberal, Kansas 67901 |
| Battle Creek Health System Cancer Care Center | Battle Creek, Michigan 49017 |
| Hackley Hospital | Muskegon, Michigan 49443 |
| Munson Medical Center | Traverse City, Michigan 49684 |
| University Cancer Center at University of Washington Medical Center | Seattle, Washington 98195 |
| Group Health Central Hospital | Seattle, Washington 98104 |
| Mountain States Tumor Institute at St. Luke's Regional Medical Center | Boise, Idaho 83712-6297 |
| Butterworth Hospital at Spectrum Health | Grand Rapids, Michigan 49503-2560 |
| Decatur Memorial Hospital Cancer Care Institute | Decatur, Illinois 62526 |
| Edward Hospital Cancer Center | Naperville, Illinois 60540 |
| Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
| Mecosta County Medical Center | Big Rapids, Michigan 49307 |
| Providence Cancer Institute at Providence Hospital - Southfield Campus | Southfield, Michigan 48075 |
| Community Oncology Group at Cleveland Clinic Cancer Center | Independence, Ohio 44131 |
| Cleveland Clinic - Wooster | Wooster, Ohio 44691 |
| Minor and James Medical, PLLC | Seattle, Washington 98104 |
| Polyclinic First Hill | Seattle, Washington 98122 |
| Cancer Center of Kansas, PA - Chanute | Chanute, Kansas 66720 |
| Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas 67042 |
| Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
| Cancer Center of Kansas, PA - Kingman | Kingman, Kansas 67068 |
| Cancer Center of Kansas, PA - Newton | Newton, Kansas 67114 |
| Cancer Center of Kansas, PA - Parsons | Parsons, Kansas 67357 |
| Cancer Center of Kansas, PA - Pratt | Pratt, Kansas 67124 |
| Cancer Center of Kansas, PA - Salina | Salina, Kansas 67401 |
| Cotton-O'Neil Cancer Center | Topeka, Kansas 66606 |
| Cancer Center of Kansas, PA - Wellington | Wellington, Kansas 67152 |
| Cancer Center of Kansas, PA - Wichita | Wichita, Kansas 67214 |
| Associates in Womens Health, PA - North Review | Wichita, Kansas 67208 |
| Cancer Center of Kansas, PA - Medical Arts Tower | Wichita, Kansas 67208 |
| Cancer Center of Kansas, PA - Winfield | Winfield, Kansas 67156 |
| Regional Cancer Center at Memorial Medical Center | Springfield, Illinois 62781-0001 |
| Providence Cancer Center | Anchorage, Alaska 99508 |
| Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
| Metro Health Hospital | Grand Rapids, Michigan 49506 |
