Clinical trial NCT00126191: Intensive Chemotherapy and Rituximab in the Treatment of Burkitt Lymphoma
Official title: Phase II Study of Intensive Chemotherapy and Rituximab in Burkitt Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Burkitt Lymphoma
Non-Hodgkins Lymphoma
Atypical Burkitt Lymphoma
Keywords: Burkitt Lymphoma
atypical Burkitt lymphoma
Non-Hodgkin's Lymphoma
rituximab
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Beth Israel Deaconess Medical Center
name: Brigham and Women's Hospital
First posted: 2005-08-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Response Rates (CR and PR) in Adults With Burkitt/Atypical Burkitt
timeFrame: 3 years
Secondary outcomes:
measure: Disease Free Survival
timeFrame: Until disease progression up to 120 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Ann S. La Casce, MD
role: PRINCIPAL_INVESTIGATOR
References: