Trial Search Results

Rituximab and Combination Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Non-Hodgkin's Lymphoma

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Eastern Cooperative Oncology Group

Collaborator: National Cancer Institute (NCI)

Intervention(s):

  • Biological: filgrastim
  • Biological: rituximab
  • Drug: carboplatin
  • Drug: cyclophosphamide
  • Drug: doxorubicin hydrochloride
  • Drug: etoposide
  • Drug: ifosfamide
  • Drug: prednisone
  • Drug: vincristine

Phase:

Phase 2

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

Ages Eligible for Study

18 Years - 70 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting