Know Cancer

or
forgot password

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


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

Thank you

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 CenterMaywood, Illinois  60153-5500
CCOP - WichitaWichita, Kansas  67214-3882
Providence Saint Joseph Medical Center - BurbankBurbank, California  91505
CCOP - GreenvilleGreenville, South Carolina  29615
CCOP - Grand RapidsGrand Rapids, Michigan  49503
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Wesley Medical CenterWichita, Kansas  67214
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Alaska Regional Hospital Cancer CenterAnchorage, Alaska  99508
Southwest Medical CenterLiberal, Kansas  67901
Battle Creek Health System Cancer Care CenterBattle Creek, Michigan  49017
Hackley HospitalMuskegon, Michigan  49443
Munson Medical CenterTraverse City, Michigan  49684
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Group Health Central HospitalSeattle, Washington  98104
Mountain States Tumor Institute at St. Luke's Regional Medical CenterBoise, Idaho  83712-6297
Butterworth Hospital at Spectrum HealthGrand Rapids, Michigan  49503-2560
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Edward Hospital Cancer CenterNaperville, Illinois  60540
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Mecosta County Medical CenterBig Rapids, Michigan  49307
Providence Cancer Institute at Providence Hospital - Southfield CampusSouthfield, Michigan  48075
Community Oncology Group at Cleveland Clinic Cancer CenterIndependence, Ohio  44131
Cleveland Clinic - WoosterWooster, Ohio  44691
Minor and James Medical, PLLCSeattle, Washington  98104
Polyclinic First HillSeattle, Washington  98122
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cotton-O'Neil Cancer CenterTopeka, Kansas  66606
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
Providence Cancer CenterAnchorage, Alaska  99508
Lacks Cancer Center at Saint Mary's Health CareGrand Rapids, Michigan  49503
Metro Health HospitalGrand Rapids, Michigan  49506