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Status: RecruitingPhase: Phase 2Diagnosis: Non-Hodgkin's LymphomaNCT ID: NCT01092182
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 10-116
Background: - Burkitt lymphoma/leukemia (BL) is highly treatable, but most of the standard therapies require multiple doses of intensive chemotherapy that may require long hospital stays and frequently have severe side effects. In addition, BL is a fairly common type of cancer in patients who also have human immunodeficiency virus (HIV), but treatment outcomes are poor because standard treatments do not work very well in HIV-positive patients and the more intense treatment regimens are highly toxic. New approaches are needed that expand the ways to treat BL with the same efficiency but with reduced side effects. - DA-EPOCH-R is a standard chemotherapy treatment that consists of the drugs etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab. It may be able to treat BL with similar effectiveness but with fewer side effects. Researchers are interested in confirming the results of previous studies that investigated the effectiveness of DA-EPOCH-R in treating BL. Objectives: - To determine the safety and effectiveness of DA-EPOCH-R in treating Burkitt lymphoma. Eligibility: - Individuals at least 18 years of age who have been diagnosed with Burkitt lymphoma and have not had any prior chemotherapy treatments. Design: - Individuals will have a series of blood and other tests to determine their suitability for participating in the study. Eligible participants will be divided into high-risk and low-risk groups based on their disease prognosis and the possibility that the BL may or already has spread into the central nervous system. - Participants will receive intravenous infusion of the six chemotherapy drugs in DA-EPOCH-R in 21-day treatment cycles. The exact doses will be adjusted depending on participants white blood cell counts and other tests. - High-risk participants will receive six cycles of DA-EPOCH-R. To treat BL that may have entered the central nervous system, high-risk participants will also receive infusions of other chemotherapy drugs into their spinal fluid. - Low-risk participants will receive up to six cycles of DA-EPOCH-R, with an additional dose of rituximab during each cycle. - Frequent blood and urine tests will be performed during treatment, as well as body imaging scans and other tests of cancer progression as directed by the study doctors. Participants will receive additional medicines to help prevent possible adverse side effects of DA-EPOCH-R. - Participants who respond successfully to the treatment will be asked to return for follow-up exams every 3 months for the first 18 months, then every year for the next 3 years. Participants who do not respond successfully to the treatment will be given the opportunity to participate in additional research and treatment protocols, if any are available.
Conducting Institutions: Dana-Farber Cancer Institute, Massachusetts General Hospital, Beth-Israel Deaconess Medical Center
Overall PI: Ann LaCasce, MD,
Dana-Farber Cancer Institute
Site-responsible Investigators: Robin Joyce, MD,
Beth Israel Deaconess Medical CenterJeremy Abramson, MD,
Massachusetts General Hospital
Contacts: Dana-Farber Cancer Institute:
firstname.lastname@example.orgBeth-Israel Deaconess Medical Center:
Cancer Trials Call Center, 617-667-3060Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100