NCT00070018
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
PHASE2
COMPLETED
NCT00070018
INTERVENTIONAL
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
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.
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
Lymphoma
- TREATMENT
-
- Type: BIOLOGICAL
- Name: rituximab
- Description: 250 mg/m\^2, as part of Zevalin regimen
- Arm Group Labels: CHOP + RT + Zevalin
-
- Type: DRUG
- Name: Cyclophosphamide
- Description: 750 mg/m\^2
- Arm Group Labels: CHOP + RT + Zevalin
-
- Type: DRUG
- Name: doxorubicin hydrochloride
- Description: 50 mg/m\^2
- Arm Group Labels: CHOP + RT + Zevalin
-
- Type: DRUG
- Name: prednisone
- Description: 100 mg
- Arm Group Labels: CHOP + RT + Zevalin
-
- Type: DRUG
- Name: vincristine sulfate
- Description: 1.4 mg/m\^2
- Arm Group Labels: CHOP + RT + Zevalin
-
- Type: RADIATION
- Name: radiation therapy
- Description: 4000-5000 cGy total
- Arm Group Labels: CHOP + RT + Zevalin
-
- Type: BIOLOGICAL
- Name: Yttrium-90 ibritumomab tiuxetan
- Description: 0.4 mCi/kg
- Arm Group Labels: CHOP + RT + Zevalin
-
- Type: BIOLOGICAL
- Name: Indium-111 ibritumomab tiuxetan
- Description: 5 mCi
- Arm Group Labels: CHOP + RT + Zevalin
- SWOG Cancer Research Network