Pixantrone, Cytarabine, Methylprednisolone, and Cisplatin in Treating Patients With Aggressive Non-Hodgkin's Lymphoma in First Relapse
Lymphoma
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring recurrent adult diffuse large cell lymphoma, anaplastic large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent grade 3 follicular lymphoma, recurrent adult Burkitt lymphoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed aggressive non-Hodgkin's lymphoma (NHL) Any stage, with or without B symptoms The following subtypes are eligible: Diffuse large cell (B and T cell types) Anaplastic large cell Diffuse mixed cell Immunoblastic large cell Follicular large cell Transformed follicular NHL Diffuse aggressive not otherwise classified Burkitt-like lymphoma Bone marrow positive or negative At least 1 measurable lesion Patients with bone marrow as the only site of disease are eligible without a measurable lesion No more than 1 episode of progressive disease, occurring after a response (complete response [CR], complete response unconfirmed [CR_u], or partial response [PR]) to prior chemotherapy* NOTE: *Patients with less than a CR, CRu, or PR and no progression, but who are good candidates for high-dose chemotherapy with stem cell support may be eligible (will be decided on an individual basis) No chemotherapy-refractory disease, defined as follows: Stable or progressive disease documented at restaging immediately after the completion of induction therapy No lymphoblastic lymphoma, or mantle cell lymphoma PATIENT CHARACTERISTICS: Age 18 and over Performance status WHO 0-1 Life expectancy At least 3 months Hematopoietic Neutrophil count at least 1,500/mm^3* Platelet count at least 100,000/mm^3* NOTE: *Lower values may be accepted if clearly due to bone marrow involvement by lymphoma Hepatic Bilirubin no greater than 1.5 times upper limit of normal (ULN)* AST or ALT no greater than 2.0 times ULN* Alkaline phosphatase no greater than 2.0 times ULN* No history or clinical symptoms of hepatitis B or hepatitis C virus Patients with seropositivity due to prior vaccination for hepatitis B are eligible NOTE: *Higher values may be accepted if clearly due to liver involvement by lymphoma Renal Creatinine no greater than 1.5 mg/dL Cardiovascular LVEF at least 50% by MUGA No clinically significant cardiovascular abnormalities No New York Heart Association grade II-IV cardiovascular disease No myocardial infarction within the past 6 months No severe cardiac arrhythmia No uncontrolled hypertension Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study participation HIV negative No clinically significant neurological abnormalities No condition that would preclude study safety or interfere with study results No concurrent serious uncontrolled infection PRIOR CONCURRENT THERAPY: Biologic therapy Prior rituximab immediately after the first chemotherapy regimen allowed Chemotherapy See Disease Characteristics See Biologic therapy At least 6 months since prior anthracycline therapy (e.g., cyclophosphamide, doxorubicin, vincristine, and prednisone [CHOP]) More than 2 years since prior fludarabine More than 2 years since prior nitrosoureas More than 1 year since prior platinum-based chemotherapy or cytarabine, unless a CR or CR_u was achieved No prior cumulative dose of cisplatin greater than 600 mg/m^2 No prior single or cumulative dose of doxorubicin greater than 450 mg/m^2 Endocrine therapy Not specified Radiotherapy No prior radiotherapy to the whole pelvis No prior radioimmunotherapy Surgery More than 4 weeks since prior major thoracic and/or abdominal surgery At least 1 week since prior minor surgery Other Recovered from prior therapy Alopecia allowed Grade 1 peripheral neuropathy allowed More than 30 days since prior participation in another investigational drug study No other concurrent investigational drugs
Sites / Locations
- Arizona Oncology Associates - Craycroft Road Offices
- City of Hope Comprehensive Cancer Center
- USC/Norris Comprehensive Cancer Center and Hospital
- Rocky Mountain Cancer Centers - Colorado Springs
- Rocky Mountain Cancer Centers - Denver Midtown
- Delaware Clinical & Laboratory Physicians
- Pasco, Hernando Oncology Associates, P.A.
- Hematology-Oncology Associates of Illinois
- Markey Cancer Center at University of Kentucky Chandler Medical Center
- Louisiana State University Health Sciences Center - Shreveport
- Massachusetts General Hospital Cancer Center
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
- North Shore University Hospital
- SUNY Upstate Medical University Hospital
- Duke Comprehensive Cancer Center
- Piedmont Hematology-Oncology Associates
- Gabrail Cancer Center - Canton Office
- Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
- Cleveland Clinic Taussig Cancer Center
- Cancer Care Associates-West
- Providence Cancer Center at Providence Portland Medical Center
- Penn State Cancer Institute at Milton S. Hershey Medical Center
- Cancer Centers of the Carolinas - Eastside
- Baylor University Medical Center
- University of Texas - MD Anderson Cancer Center
- Fairfax Northern Virginia Hematology Oncology, P.C. - Fairfax
- Medical College of Wisconsin Cancer Center
- Hospital Auxilio Mutuo