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Rituximab and Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Non-Hodgkin's Lymphoma
Not Recruiting
Trial ID: NCT00274924
Purpose
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different
ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and
help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in
different ways to stop the growth of cancer cells, either by killing the cells or by stopping
them from dividing. Giving rituximab together with combination chemotherapy may kill more
cancer cells.
PURPOSE: This phase II trial is studying how well giving rituximab together with combination
chemotherapy works in treating patients with stage II, stage III, or stage IV diffuse large
B-cell non-Hodgkin's lymphoma.
Official Title
Response-Adapted Therapy for Aggressive Non-Hodgkin's Lymphomas Based on Early [18F] FDG-PET Scanning
Stanford Investigator(s)
Ranjana Advani
Saul A. Rosenberg, MD, Professor of Lymphoma
Harlan Pinto
Associate Professor of Medicine (Oncology) and of Otolaryngology - Head & Neck Surgery
Eligibility
INCLUSION CRITERIA:
- Diffuse large B-cell non-Hodgkin's lymphoma
- Bulky stage II (bulk defined as any lesion ≥ 10 cm) or stage III or IV disease
- The following lymphoma types are excluded:
- Primary central nervous system lymphoma
- Transformed low-grade lymphoma (prior history of low-grade lymphoma or clear
presence of low-grade lymphoma on histologic sections)
- Primary mediastinal B-cell lymphoma or testicular lymphoma (consolidative
radiotherapy is usually indicated)
- Immunodeficiency-related lymphoma (i.e., after organ or bone marrow
transplant)
- Measurable disease
- Patient must have at least one objective measurable disease site (i.e.,
measurable in at least 2 perpendicular parameters)
- Measurable disease in the liver is required if the liver is the only site of
lymphoma involvement
- Abnormal positron emission tomography scans will not constitute evaluable
disease, unless verified by CT scan or other appropriate imaging
- Eastern Cooperative Oncology Group (ECOG) performance status 0-3
- For patients > 50 years of age, a normal ejection fraction by ECHO or Multigated
Acquisition Scan (MUGA) is required within 6 weeks prior to registration
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count > 100,000/mm^3
- Creatinine < 2.0 mg/dL
- Bilirubin < 2 mg/dL (may be up to 3.0 mg/dL if due to liver involvement by lymphoma)
EXCLUSION CRITERIA:
- Prior chemotherapy or radiation therapy for lymphoma
- Prior anthracyclines or platinum compounds used as systemic chemotherapy
- Prior radiation therapy to the mediastinum or to ≥ 25% of the bone marrow
- Concurrent pentostatin or trastuzumab (Herceptin®)
- Pregnant or nursing
- Prior malignancy within the past 5 years unless it was in situ OR was treated with
curative intent AND the patient has remained relapse-free
- HIV positive
Intervention(s):
biological: filgrastim
biological: rituximab
drug: carboplatin
drug: cyclophosphamide
drug: doxorubicin hydrochloride
drug: etoposide
drug: ifosfamide
drug: prednisone
drug: vincristine
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061