Clinical Trial: Intensive Chemotherapy and Rituximab in the Treatment of Burkitt Lymphoma

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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 Summary:

  • 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.

Sponsor: Dana-Farber Cancer Institute

Current Primary Outcome: Response Rates (CR and PR) in Adults With Burkitt/Atypical Burkitt [ Time Frame: 3 years ]

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.



Original Primary Outcome: To evaluate the response rates in adults with Burkitt/atypical Burkitt.

Current Secondary Outcome: Disease Free Survival [ Time Frame: Until disease progression up to 120 months ]

Participants are followed after completion of protocol therapy until disease progression to determine disease free survival.


Original Secondary Outcome:

  • To assess the disease-free survival of adults with Burkitt/atypical Burkitt
  • To assess the safety of the treatment


Information By: Dana-Farber Cancer Institute

Dates:
Date Received: August 2, 2005
Date Started: July 2005
Date Completion:
Last Updated: April 17, 2013
Last Verified: April 2013