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S0313 Cyclophosphamide, Doxor...

S0313 Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, and Radiation Therapy Followed By Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Stage I or Stage II Non-Hodgkin's Lymphoma

Last Updated: 2022-01-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2015-01-08

Brief Summary

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RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Monoclonal antibodies, such as rituximab and yttrium Y 90 ibritumomab tiuxetan, can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. Combining chemotherapy with radiation therapy and monoclonal antibody therapy may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy and monoclonal antibody therapy works in treating patients with stage I or stage II non-Hodgkin's lymphoma.

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Detailed Description

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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.

Conditions

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Lymphoma

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CHOP + RT + Zevalin

Patients first receive 3 cycles (21 days each) of CHOP, consisting of: cyclophosphamide 750 mg/m\^2 on day 1, doxorubicin 50 mg/m\^2 on day 1, vincristine 1.4 mg/m\^2 on day 1, and prednisone 100 mg on days 1-5. Patients receive 4000-5000 cGy of radiation therapy in 25 fractions, starting 3 weeks after completion of CHOP. 3-6 weeks after completing RT, patients receive Zevalin, which consists of: rituximab 250 mg/m\^2 on days 1 and 7, 8 or 9; In-111 ibritumomab tiuxetan 5 mCi within 4 hours after rituximab on day 1; and Y-90 ibritumomab tiuxetan 0.4 mCi/kg within 4 hours after rituximab on day 7, 8 or 9.

Group Type EXPERIMENTAL

rituximab

Intervention Type BIOLOGICAL

250 mg/m\^2, as part of Zevalin regimen

Cyclophosphamide

Intervention Type DRUG

750 mg/m\^2

doxorubicin hydrochloride

Intervention Type DRUG

50 mg/m\^2

prednisone

Intervention Type DRUG

100 mg

vincristine sulfate

Intervention Type DRUG

1.4 mg/m\^2

radiation therapy

Intervention Type RADIATION

4000-5000 cGy total

Yttrium-90 ibritumomab tiuxetan

Intervention Type BIOLOGICAL

0.4 mCi/kg

Indium-111 ibritumomab tiuxetan

Intervention Type BIOLOGICAL

5 mCi

Interventions

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rituximab

250 mg/m\^2, as part of Zevalin regimen

Intervention Type BIOLOGICAL

Cyclophosphamide

750 mg/m\^2

Intervention Type DRUG

doxorubicin hydrochloride

50 mg/m\^2

Intervention Type DRUG

prednisone

100 mg

Intervention Type DRUG

vincristine sulfate

1.4 mg/m\^2

Intervention Type DRUG

radiation therapy

4000-5000 cGy total

Intervention Type RADIATION

Yttrium-90 ibritumomab tiuxetan

0.4 mCi/kg

Intervention Type BIOLOGICAL

Indium-111 ibritumomab tiuxetan

5 mCi

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas P. Miller, MD

Role: STUDY_CHAIR

University of Arizona

Oliver W. Press, MD, PhD

Role: STUDY_CHAIR

Fred Hutchinson Cancer Center

Baldassarre D. Stea, MD, PhD

Role: STUDY_CHAIR

University of Arizona

Louis S. Constine, MD

Role: STUDY_CHAIR

James P. Wilmot Cancer Center

Locations

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Alaska Regional Hospital Cancer Center

Anchorage, Alaska, United States

Site Status

Providence Cancer Center

Anchorage, Alaska, United States

Site Status

Providence Saint Joseph Medical Center - Burbank

Burbank, California, United States

Site Status

Mountain States Tumor Institute at St. Luke's Regional Medical Center

Boise, Idaho, United States

Site Status

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, United States

Site Status

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, United States

Site Status

Edward Hospital Cancer Center

Naperville, Illinois, United States

Site Status

Regional Cancer Center at Memorial Medical Center

Springfield, Illinois, United States

Site Status

Cancer Center of Kansas, PA - Chanute

Chanute, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Dodge City

Dodge City, Kansas, United States

Site Status

Cancer Center of Kansas, PA - El Dorado

El Dorado, Kansas, United States

Site Status

Cancer Center of Kansas-Independence

Independence, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Kingman

Kingman, Kansas, United States

Site Status

Southwest Medical Center

Liberal, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Newton

Newton, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Parsons

Parsons, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Pratt

Pratt, Kansas, United States

Site Status

Cancer Center of Kansas, PA - Salina

Salina, Kansas, United States

Site Status

Cotton-O'Neil Cancer Center

Topeka, Kansas, United States

Site Status