NCT00005089

S0014 Combination Chemotherapy Plus Rituximab and Radiation Therapy in Treating Patients With Stage I or Stage II Non-Hodgkin's Lymphoma

Study Contact:

Study Phase:

PHASE2

Recruitment Status:

COMPLETED

NCT ID:

NCT00005089

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

Evaluation of CHOP Plus Rituximab Plus Involved Field Radiotherapy for Stages I, IE, and Non-Bulky Stages II and IIE, CD20 Positive, High-Risk Localized Aggressive Histologies of Non-Hodgkin's Lymphoma

Summary

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

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus rituximab and radiation therapy in treating patients who have stage I or stage II non-Hodgkin's lymphoma.

Eligibility

DISEASE CHARACTERISTICS: Histologically confirmed stage I, IE, or non-bulky II or IIE non-Hodgkin's lymphoma of one 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) Lymphoma must express CD20 All disease must be encompassable in a single radiation port (including any resected disease) Must have at least 1 of the following adverse prognostic features: Non-bulky stage II or non-bulky stage IIE disease Over 60 years of age Zubrod performance status of 2 Elevated serum LDH 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: No medical contraindications to CHOP chemotherapy or rituximab No prior malignancy within past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No AIDS or HIV Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior monoclonal antibody therapy Chemotherapy: No prior chemotherapy for lymphoma Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy for lymphoma Surgery: Not specified

Disease(s) and\or Condition(s)

Lymphoma

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: BIOLOGICAL
- Name: rituximab
- Description: 375 mg/m\^2 on days 1,8 of cycle 1, then on days 1-3 of cycles 2-3.
- Arm Group Labels: CHOP + Rituximab + RT
- Type: DRUG
- Name: cyclophosphamide
- Description: 750 mg/m\^2 on day 10 of cycle 1, then on day 21 of cycles 2-3.
- Arm Group Labels: CHOP + Rituximab + RT
- Type: DRUG
- Name: doxorubicin hydrochloride
- Description: 50 mg/m\^2 on day 10 of cycle 1, then on day 21 of cycles 2-3.
- Arm Group Labels: CHOP + Rituximab + RT
- Type: DRUG
- Name: prednisone
- Description: 100 mg on days 10-14 of cycle 1, then on days 3-7 of cycles 2-3.
- Arm Group Labels: CHOP + Rituximab + RT
- Type: DRUG
- Name: vincristine sulfate
- Description: 1.4 mg/m\^2 on day 10 of cycle 1, then on day 3 of cycles 2-3.
- Arm Group Labels: CHOP + Rituximab + RT
- Type: RADIATION
- Name: radiation therapy
- Description: 4000-5500 cGy given in 25 fractions starting 3 weeks after completion of CHOP + Rituximab.
- Arm Group Labels: CHOP + Rituximab + RT

Sponsor

SWOG Cancer Research Network