Lymphoma
Conditions
Keywords
stage I adult diffuse large cell lymphoma, stage I adult Burkitt lymphoma, stage I mantle cell lymphoma, contiguous stage II mantle cell lymphoma, contiguous stage II adult diffuse large cell lymphoma, contiguous stage II adult Burkitt lymphoma, noncontiguous stage II mantle cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult Burkitt lymphoma
Brief 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.
Detailed description
OBJECTIVES: I. Assess two year progression free survival after treatment with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) plus rituximab followed by radiotherapy in patients with stage I, IE, or non-bulky stage II or IIE high risk localized intermediate or high grade non-Hodgkin's lymphoma. II. Determine the toxicity of this treatment in these patients. OUTLINE: Patients receive rituximab IV on days 1 and 8 of the first course, then on day 1 of courses 2 and 3. Patients receive cyclophosphamide IV over 1-2 hours, doxorubicin IV, and vincristine IV on day 10 of the first course, then on day 3 of courses 2 and 3. Patients receive oral prednisone on days 10-14 of the first course, then on days 3-7 of courses 2 and 3. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Chemotherapy is followed by radiotherapy administered 5 days a week for 4-5 weeks. Patients are followed every 6 months for two years, and then annually thereafter. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Interventions
RADIATIONradiation therapy
4000-5500 cGy given in 25 fractions starting 3 weeks after completion of CHOP + Rituximab.
BIOLOGICALrituximab
375 mg/m\^2 on days 1,8 of cycle 1, then on days 1-3 of cycles 2-3.
DRUGcyclophosphamide
750 mg/m\^2 on day 10 of cycle 1, then on day 21 of cycles 2-3.
DRUGdoxorubicin hydrochloride
50 mg/m\^2 on day 10 of cycle 1, then on day 21 of cycles 2-3.
DRUGprednisone
100 mg on days 10-14 of cycle 1, then on days 3-7 of cycles 2-3.
DRUGvincristine sulfate
1.4 mg/m\^2 on day 10 of cycle 1, then on day 3 of cycles 2-3.
Sponsors
National Cancer Institute (NCI)
SWOG Cancer Research Network
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | every 6 weeks while on protocol treatment, then every 6 months for 2 years, then annually thereafter |
Countries
United States
Outcome results
None listed