Clinical Trial: Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed, HIV-Associated Burkitt's Lymphoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Prospective Phase II Study of a High Dose, Short Course Regimen (R-CODOX-M/IVAC) Including CNS Penetration and Intensive IT Prophylaxis in HIV-Associated Burkitt's and Atypical B

Brief Summary:

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating patients with newly diagnosed, HIV-associated Burkitt's lymphoma.


Detailed Summary:

OBJECTIVES:

Primary

  • Determine the efficacy of rituximab, cyclophosphamide, vincristine, doxorubicin hydrochloride, and high-dose methotrexate (R-CODOX-M ) alone or alternating with rituximab and ifosfamide, etoposide phosphate, and high-dose cytarabine (IVAC) and intrathecal CNS prophylaxis in patients with newly diagnosed, previously untreated, HIV-associated Burkitt's lymphoma or atypical Burkitt's lymphoma.
  • Determine the safety of this regimen in these patients.

Secondary

  • Evaluate downstream effectors of apoptosis as mechanisms of chemotherapy resistance and prognosis and perform exploratory analysis of their relationship to treatment effect.
  • Evaluate multi-drug resistance gene expression as a mechanism of chemotherapy resistance and prognosis and perform exploratory analysis of their relationship to treatment effect.
  • Confirm the use of flow cytometry in the identification of occult leptomeningeal disease and determine whether abnormal flow cytometry is predictive when CNS cytology is negative for malignant cells.
  • Determine the biologic and prognostic significance of Epstein-Barr virus (EBV)-positive Burkitt's lymphoma in the highly active antiretroviral therapy era and perform exploratory analysis of their relationship to treatment effect.
  • Compare genotyping in patients with HIV-associated Burkitt's lymphoma with that of patients who are HIV-negative and determine whether they are uniform in their genetic profile or whether some cases are more like diffuse large B-cell lymphoma.<
    Sponsor: AIDS Malignancy Consortium

    Current Primary Outcome: Overall Survival (OS) at 1 Year [ Time Frame: 1 year post treatment ]

    Original Primary Outcome:

    Current Secondary Outcome:

    • Complete Response Rate [ Time Frame: 6-8 weeks post treatment, every 4 months post-treatment for 2 years ]
    • Failure-free Survival (FFS) [ Time Frame: 6-8 weeks post treatment, every 4 months post-treatment for 2 years ]
    • Event-free Survival (EFS) [ Time Frame: 6-8 weeks post treatment, every 4 months post-treatment for 2 years ]
    • Toxicity [ Time Frame: baseline through 2 years post-treatment ]
    • Incidence of Infection-related Deaths [ Time Frame: baseline through 2 years post-treatment ]
    • Correlation of C-flip Expression, p53 Mutations, and Multidrug Resistance Expression With OS, FFS, and EFS [ Time Frame: baseline through 2 years post-treatment ]
    • Utility of Flow Cytometry in Detecting Leptomeningeal Disease [ Time Frame: baseline and 6-8 weeks post-treatment ]
    • Degree of Disconcordance Between Flow Cytometry and CNS Cytology Results [ Time Frame: baseline ]
    • Biologic and Prognostic Significance of Epstein-Barr Virus (EBV) at Diagnosis and Correlation With OS, FFS, and EFS [ Time Frame: baseline through 2 years post-treatment ]
    • Correlation of EBV Load Measurements With OS, FFS, and EFS [ Time Frame: baseline through 2 years post-treatment ]


    Original Secondary Outcome:

    Information By: AIDS Malignancy Consortium

    Dates:
    Date Received: October 25, 2006
    Date Started: September 2006
    Date Completion:
    Last Updated: August 27, 2014
    Last Verified: August 2014