Clinical Trials Directory

A Phase II Trial of R-CHOP Followed by Zevalin Radioimmunotherapy for Patients With Previously Untreated Stages I and II CD20+ Diffuse Large Cell Non-Hodgkin's Lymphoma

This phase II trial is studying how well giving rituximab together with combination chemotherapy and 90-Yttrium ibritumomab tiuxetan works in treating patients with stage I or stage II lymphoma. Drugs used in chemotherapy, such as prednisone, cyclophosphamide, doxorubicin, and vincristine, work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab and yttrium 90-Yttrium ibritumomab tiuxetan can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. Combining a monoclonal antibody with combination chemotherapy and a radiolabeled monoclonal antibody may kill more cancer cells.

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • biological : rituximab
  • drug : doxorubicin
  • drug : prednisone
  • drug : vincristine
  • drug : cyclophosphamide
  • procedure : positron emission tomography
  • radiation : indium In 111 ibritumomab tiuxetan
  • radiation : radiation therapy

Phase: Phase 2

Eligibility

Ages Eligible For Study:

18 Years - N/A

Inclusion Criteria

- Patients must have histologically confirmed diagnosis of diffuse large cell lymphoma - Patients must be stage I or II (Modified Ann Arbor staging) - Baseline measurements and evaluations must be obtained within 4 weeks of registration to the study; abnormal PET scans will not constitute evaluable disease unless verified by CT scan or other appropriate imaging; patients must have at least one objective measurable disease parameter (a lesion with at least 1 dimension > 1.5 cm); or if they are stage 1 - Stage I patients must have at least one of the following risk factors: - Age >= 60 years - Bulky disease (>= 5 cm in at least one dimension) - Elevated Lactate Dehydrogenase (LDH) above institutional upper limit of normal - Eastern Cooperative Oncology Group (ECOG) performance status = 2 - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 - Absolute neutrophil count >= 1500/mm^3 (includes neutrophils and bands) - Platelet count >= 100,000/mm^3 - Creatinine < 2.0 mg/dl - Total bilirubin < 2 mg/dl (may be up to 3.0 mg/dl if due to liver involvement by lymphoma); patients with elevated total bilirubin should have a direct bilirubin checked; if the direct bilirubin is normal there is no need for a dose reduction - Patients must have left ventricular ejection fraction (LVEF) of > 45% - Patients must be tested for hepatitis B (HBV) surface antigen within 2 weeks of registration - NOTE: Patients who test positive will be allowed to participate but must be followed closely for clinical and laboratory signs of active HBV infection and for signs of hepatitis

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