Status:
TERMINATED
Intensive Chemotherapy and Rituximab in the Treatment of Burkitt Lymphoma
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Conditions:
Burkitt Lymphoma
Non-Hodgkins Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00126191
Start Date
July 1 2005
End Date
June 1 2011
Last Update
May 23 2013
Active Locations (2)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215