S0349 Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone With or Without Oblimersen in Treating Patients With Advanced Diffuse Large B-Cell Non-Hodgkin's Lymphoma

Stopped early · Phase 2

Conditions studied: Contiguous Stage II Adult Diffuse Large Cell Lymphoma, Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma, Stage III Adult Diffuse Large Cell Lymphoma, Stage IV Adult Diffuse Large Cell Lymphoma

In brief

This randomized phase II trial is studying rituximab and combination chemotherapy to see how well they work compared to oblimersen, rituximab, and combination chemotherapy in treating patients with advanced diffuse large B-cell non-Hodgkin's lymphoma. Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop cancer cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of anticancer drugs by making cancer cells more sensitive to the drugs. Combining rituximab and combination chemotherapy with oblimersen may kill more cancer cells

Key facts

Study ID: NCT00080847
Run by: National Cancer Institute (NCI)
People needed: 160
Starts: 2004-03-01
Last updated by the study team: 2013-01-07

Who can join

Age: 19 and older, up to 59. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

All patients must have previously untreated stage III, IV, or bulky stage II diffuse large B-cell non-Hodgkin's lymphoma which is positive for CD20
Adequate sections from the original diagnostic specimen must be available for submission for review; an adequate biopsy requires sufficient tissue to establish the architecture and a REAL or WHO histologic subtype with certainty; thus, core biopsies, especially multiple core biopsies MAY be adequate; whereas, needle aspirations or cytologies are not adequate
Patients may also be registered to SWOG-8947 and SWOG-8819
Patients must have an age-adjusted International Prognostic Index score of 0 or 1
All patients must have bidimensionally measurable disease documented within 28 days prior to registration; patients with non-measurable disease in addition to measurable disease must have all non-measurable disease assessed within 42 days prior to registration
Patients must have a unilateral bone marrow aspirate and biopsy performed within 42 days prior to registration
Patients must have a CT scan of the chest and abdomen/pelvis performed within 28 days prior to registration
Patients must not have clinical evidence of central nervous system involvement by lymphoma; any laboratory or radiographic tests performed to assess CNS involvement must be negative within 42 days of registration
Patients must not have a previous diagnosis of indolent lymphoma (histologic transformation are ineligible); as patients with nodal diffuse large ell lymphoma may have bone marrow involvement with small lymphocytes, such patients are eligible
Patients must not have received prior chemotherapy, radiation, or antibody therapy for lymphoma
All patients must have a Zubrod performance status of 0-2
Serum LDH must be measured within 28 days prior to registration
Patients must have a cardiac ejection fraction >= 45% by MUGA scan or an ECHO with no significant abnormalities within 42 days prior to registration
Patients known to be HIV positive, or who have a history of solid organ transplantation are ineligible as the biology and natural history of HIV associated, or post transplant lymphomas are very different than that of de novo diffuse large cell lymphomas; patients at high risk of hepatitis B virus infection should be screened before initiation of rituximab
Patients requiring continuing supplemental oxygen therapy are ineligible
No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
Pregnant or nursing women may not participate due to the potential for congenital abnormalities, and of harm to nursing infants due to this treatment regimen; women or men of reproductive potential may no participate unless they have agreed to use an effective contraceptive method
If day 28 or 42 falls on a weekend or holiday, the limit may be extended to the next working day
In calculating days of tests and measurements, the day a test or measurement is done is considered day 0; therefore, if a test is done on a Monday, the Monday 4 weeks later would be considered day 28; this allows for efficient patient scheduling without exceeding the guidelines
All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
At the time of patient registration, the treating institution's name and ID number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base

Where it is running

Southwest Oncology Group — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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