Intensive Chemotherapy and Rituximab in the Treatment of Burkitt Lymphoma

Burkitt Lymphoma Clinical Trial

Official title:

Phase II Study of Intensive Chemotherapy and Rituximab in Burkitt Lymphoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00126191
• Other study ID #: 04-336
• Status: Terminated
• Phase: Phase 2
• First received: August 2, 2005
• Last updated: April 17, 2013
• Start date: July 2005
• Est. completion date: June 2011

Study information

• Verified date: April 2013
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: June 2011
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atypical Burkitt Lymphoma
• Burkitt Lymphoma
• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkins Lymphoma

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
• Cyclophosphamide
Low Risk/High Risk: Intravenously on day 1 and day 2 of a 14-day cycle for 3 cycles (regimen A)
• Doxorubicin
Low Risk/High Risk: Given on day 1 of a 14-day cycle for 3 cycles (regimen A)
• Vincristine
Low Risk/High Risk: Given intravenously on day 1 and day 10 of a 14-day cycle for 3 cycles (regimen A)
• 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
• Leucovorin
Low Risk/High Risk: Given on days 11, 12 and 13 of a 14-day cycle for 3 cycles (regimen A)
• Ifosfamide
High Risk: After Regimen A, Ifosomide given on days 1-5 of a 5 day cycle
• Etoposide
High Risk: After Regimen A, etoposide given days 1-5 of a 5-day cycle
• 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
• Mesna
High Risk: After regimen A, mesna is given on days 1-5 of a 5-day cycle

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Beth Israel Deaconess Medical Center, Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rates (CR and PR) in Adults With Burkitt/Atypical Burkitt	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.	3 years	No
Secondary	Disease Free Survival	Participants are followed after completion of protocol therapy until disease progression to determine disease free survival.	Until disease progression up to 120 months	No