Doxorubicin (Doxil) Combined With Rituxan, Cyclophosphamide, Vincristine and Prednisone in Newly Diagnosed Aggressive Non-Hodgkin's Lymphomas
Non-Hodgkin's Lymphoma
About this trial
This is an interventional treatment trial for Non-Hodgkin's Lymphoma
Eligibility Criteria
Inclusion Criteria: Pathologic diagnosis of Non-Hodgkin's lymphoma of B-cell origin: follicular large cell, diffuse large cell (including all B-cell variants), Burkitt or Burkitt-like lymphoma All stages of disease Measurable or evaluable tumor parameter(s) Age greater than 17 years old Karnofsky performance status greater or equal to 50% AGC greater or equal to 1.0; platelets greater or equal to 75,000(unless abnormal because of lymphoma) Bilirubin less or equal to 2.0; SGOT less or equal to 3 times upper limit of normal (unless abnormal because of lymphoma) Creatinine less or equal to 2.0 or creatinine clearance greater or equal to 60 ml/min (unless abnormal because of lymphoma) LVEF greater or equal to 45% Concurrent RT with or without steroids for emergency conditions secondary to lymphoma (i.e., CNS tumor, cord compression)are permitted Men and women of childbearing potential must agree to use adequate birth control for the duration of the therapy and for 3 months after completion of therapy Signed informed consent Exclusion Criteria: Prior systemic cytotoxic therapy or RT for lymphoma Second active tumor, other than non-melanomatous skin ca and in-situ cervical cancer HIV seropositive Primary CNS lymphoma Pregnant or nursing women Unable to comply with the requirements of the protocol, or unable to provide adequate informed consent, in the opinion of the PI
Sites / Locations
- USC/Norris Comprehensive Cancer Center and Hospital
Arms of the Study
Arm 1
Experimental
DR-COP
On cycle 1 patients receive Doxil 40 mg/m2 iv day 1 over a minimum of 60 min., Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min., Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5. On cycle 2 until study completion patients receive Doxil 40 mg/m2 iv day 1, Rituxan 375 mg/m2 iv day 1, Cyclophosphamide 750 mg/m2 iv day 1, Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5 1 cycle = 21 days. Continue treatment until 2 cycles beyond documentation of CR for a maximum of 8 cycles.