Intensive Chemotherapy and Rituximab in the Treatment of Burkitt Lymphoma
Overview[ - collapse ][ - ]
Purpose | The purpose of this study is to learn more about how well a chemotherapy regime including rituximab works in treating patients with Burkitt or atypical Burkitt lymphoma. |
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Condition | Burkitt Lymphoma Non-Hodgkins Lymphoma Atypical Burkitt Lymphoma |
Intervention | Drug: Rituximab Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Methotrexate Drug: Leucovorin Drug: Ifosfamide Drug: Etoposide Drug: Cytarabine Drug: Mesna |
Phase | Phase 2 |
Sponsor | Dana-Farber Cancer Institute |
Responsible Party | Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier | NCT00126191 |
First Received | August 2, 2005 |
Last Updated | April 17, 2013 |
Last verified | April 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | August 2, 2005 |
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Last Updated Date | April 17, 2013 |
Start Date | July 2005 |
Estimated Primary Completion Date | June 2011 |
Current Primary Outcome Measures | Response Rates (CR and PR) in Adults With Burkitt/Atypical Burkitt [Time Frame: 3 years] [Designated as safety issue: No]Complete Response (CR): Disappearance of all measurable or evaluable disease confirmed. Partial Response (PR): Reduction of 50% or greater in the sum of the products of the perpendicular diameters of all measurable. Of 8 High Risk participants, 7 met the primary response outcome. 1 High Risk participant did not meet protocol defined primary outcome response and died two months following enrollment. |
Current Secondary Outcome Measures | Disease Free Survival [Time Frame: Until disease progression up to 120 months] [Designated as safety issue: No]Participants are followed after completion of protocol therapy until disease progression to determine disease free survival. |
Descriptive Information[ + expand ][ + ]
Brief Title | Intensive Chemotherapy and Rituximab in the Treatment of Burkitt Lymphoma |
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Official Title | Phase II Study of Intensive Chemotherapy and Rituximab in Burkitt Lymphoma |
Brief Summary | The purpose of this study is to learn more about how well a chemotherapy regime including rituximab works in treating patients with Burkitt or atypical Burkitt lymphoma. |
Detailed Description | - Patients will be placed into one of two groups, "low risk" and "high risk". "Low risk" disease is defined as one area of disease measuring less than 10cm and a normal blood test called LDH (lactate hydrogenase). Patients not fitting the "low risk" criteria are considered "high risk". - If the patient has "low risk" disease their treatment cycle consist of three cycles of A. - If the patient has "high risk" disease they will receive Cycle A followed by cycle B which will then repeat. - Cycle A consists of the drugs: rituximab, cyclophosphamide, oncovin, doxorubicin and methotrexate (R-CODOX-M). The treatment cycle is approximately 14 days. A spinal tap is performed on day 1 and day 3 of the cycle and the patient will be hospitalized until between day 11 and day 13. After the patient's blood counts return to normal(usually around day 21),the next round of treatment will occur. - Cycle B consists of the drugs: rituximab, ifosfamide, VP-16 and ara-c (IVAC). The treatment cycle is approximately 5 days. A spinal tap is performed on day 4 and once blood counts return to normal the patient will start cycle A again. - After the patient has finished the treatments, they will be re-evaluated with CT scans and PET scans to determine whether or not they are in remission. Every three months for two years, blood tests and CT and PET scans will be performed. Follow up after that will be every 6 months for two years. |
Study Type | Interventional |
Study Phase | Phase 2 |
Study Design | Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition |
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Intervention | Drug: Rituximab Low Risk: Intravenously on Day 3 of the first cycle (One cycle is 14 days) then day 1 for next 2 cycles (Regimen A) High Risk: Regimen A followed by a 5-day cycle where rituximan is given on day 1 Other Names: RituxanDrug: Cyclophosphamide Low Risk/High Risk: Intravenously on day 1 and day 2 of a 14-day cycle for 3 cycles (regimen A) Other Names: CytoxanDrug: Doxorubicin Low Risk/High Risk: Given on day 1 of a 14-day cycle for 3 cycles (regimen A) Other Names: Adriamycin, RubexDrug: Vincristine Low Risk/High Risk: Given intravenously on day 1 and day 10 of a 14-day cycle for 3 cycles (regimen A) Other Names: Oncovin, vincristine sulfateDrug: Methotrexate Low Risk: Given on day 10 of a 14-day cycle for 3 cycles (regimen A) High Risk: Regimen A followed by methotrexate on day 3 and day 5 of a 5-day cycle Other Names: Rheumatrex, TrexallDrug: Leucovorin Low Risk/High Risk: Given on days 11, 12 and 13 of a 14-day cycle for 3 cycles (regimen A) Other Names: Folinic acidDrug: Ifosfamide High Risk: After Regimen A, Ifosomide given on days 1-5 of a 5 day cycle Other Names: IfexDrug: Etoposide High Risk: After Regimen A, etoposide given days 1-5 of a 5-day cycle Other Names: VepesidDrug: Cytarabine Low Risk: Given on days 1, 3, 5 and 10 of a 14-day cycle for 3 cycles (regimen A) High Risk: After regimen A, cytarabine given on days 1 and 2 of a 5-day cycle Other Names: Cytosar, Tarabine PFSDrug: Mesna High Risk: After regimen A, mesna is given on days 1-5 of a 5-day cycle Other Names: Mesnex |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Terminated |
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Estimated Enrollment | 10 |
Estimated Completion Date | June 2011 |
Estimated Primary Completion Date | December 2009 |
Eligibility Criteria | Inclusion Criteria: - Histologically documented Burkitt or atypical Burkitt according to World Health Organization (WHO) criteria. - Pathology must be reviewed at the Brigham and Women's Hospital (BWH). - Measurable or evaluable disease: Disease reproducibly measurable in two perpendicular dimensions on exam, computed tomography (CT), radiograph, or magnetic resonance imaging (MRI). Disease present on bone marrow biopsy will be considered as evaluable disease. - The following may not be used as the sole site of measurable or evaluable disease: *ascites, *pleural effusion, *bone lesion or *central nervous system (CNS) disease. - Age > 18 - Laboratory data (within 2 weeks of study registration): - ANC > 1500/ul; - platelet > 100,000/ul; - creatinine < 1.5 X normal; - creatinine clearance > 60 ml/min; - bilirubin < 1.5 X normal; - AST and ALT < 2.5 X normal; - alkaline phosphates < 3 X normal; - HIV negative; - cardiac ejection fraction > 50%. Exclusion Criteria: - Previous chemotherapy or radiation therapy. Steroids of less than 72 hours duration for impending oncologic emergency are allowed. - Uncontrolled bacterial, fungal, or viral infection. - Concomitant malignancy excluding carcinoma in situ of the cervix and basal cell carcinoma of the skin. - Serious comorbid disease. Clinically significant pulmonary symptomatology. In patients with a history of symptomatic pulmonary disease, pulmonary function tests (PFTs) should document an forced expiratory volume at 1 second (FeV1), forced vital capacity (FVC), and total lung capacity (TLC) of > 60% predicted and carbon monoxide diffusing capacity of the lung (DLCO) of > 50% predicted. No clinically significant cardiac symptomatology. The cardiac ejection fraction must be > 50%. - Pregnancy. All males and females with reproductive potential must consent to use an effective form of contraception while on study. - Major surgery within the previous 2 weeks. |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00126191 |
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Other Study ID Numbers | 04-336 |
Has Data Monitoring Committee | Yes |
Information Provided By | Dana-Farber Cancer Institute |
Study Sponsor | Dana-Farber Cancer Institute |
Collaborators | Beth Israel Deaconess Medical Center Brigham and Women's Hospital |
Investigators | Principal Investigator: Ann S. La Casce, MD Dana-Farber Cancer Institute |
Verification Date | April 2013 |
Locations[ + expand ][ + ]
Dana-Farber Cancer Institute | Boston, Massachusetts, United States, 02115 |
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Beth Israel Deaconess Medical Center | Boston, Massachusetts, United States, 02215 |