S0355 Ixabepilone in Treating Patients With Advanced Solid Tumors or Lymphomas and Liver Dysfunction
Lymphoma, Small Intestine Cancer, Unspecified Adult Solid Tumor, Protocol Specific
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring unspecified adult solid tumor, protocol specific, anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, intraocular lymphoma, primary central nervous system lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult Hodgkin lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult T-cell leukemia/lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, recurrent grade 1, 2, or 3 follicular lymphoma, recurrent mantle cell lymphoma, small intestine lymphoma, stage IV adult diffuse large cell or mixed cell lymphoma, stage IV adult diffuse small cleaved cell lymphoma, stage IV adult Burkitt lymphoma or Hodgkin lymphoma, stage IV adult immunoblastic large cell lymphoma, stage IV adult lymphoblastic lymphoma, stage IV adult T-cell leukemia/lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma, stage IV grade 1, 2, or 3 follicular lymphoma, stage IV mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, stage IV small lymphocytic lymphoma, stage IV marginal zone lymphoma, extranodal marginal zone B-cell lymphoma of MALT, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma, recurrent adult Burkitt lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult diffuse mixed cell lymphoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed solid tumor or lymphoma for which standard curative or palliative measures do not exist or are no longer effective Pathological confirmation of diagnosis not required in patients with liver mass, raised alpha-fetoprotein levels (at least 500 ng/mL), and positive serology for hepatitis consistent with a diagnosis of hepatocellular carcinoma Any solid tumor or lymphoma tumor type eligible Must have had thoracic and upper abdominal CT scan, including entire liver and adrenals, within 28 days before study entry Patients with glioma or brain metastases must be on a stable dose of corticosteroids and be seizure-free for the past month Prior whole brain or gamma knife radiotherapy required for known brain metastases No unstable or untreated (non-irradiated) brain metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status Zubrod 0-2 Life expectancy Not specified Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 No active hemolysis Hepatic See Disease Characteristics Patients with biliary obstruction for which a shunt has been placed are allowed if shunt is in place for at least 10 days and liver function is stable Abnormal liver function (bilirubin and SGOT) allowed regardless of cause (metastases or other causes) No evidence of biliary sepsis Renal Creatinine no greater than 1.5 mg/dL Cardiovascular No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other No concurrent uncontrolled illness No ongoing or active infection No uncontrolled diarrhea No peripheral neuropathy grade II or greater No psychiatric illness or social situation that would preclude study compliance HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent immunotherapy for malignancy Chemotherapy More than 2 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) No other concurrent chemotherapy for malignancy Endocrine therapy See Disease Characteristics No concurrent oral contraceptives No concurrent hormone therapy for malignancy Concurrent luteinizing hormone-releasing hormone agonists allowed Radiotherapy See Disease Characteristics More than 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy for malignancy Surgery More than 2 weeks since prior major surgery Other Recovered from prior therapy No concurrent medications that are known to be inhibitors of CYP3A4
Sites / Locations
- City of Hope Comprehensive Cancer Center
- USC/Norris Comprehensive Cancer Center and Hospital
- University of California Davis Cancer Center
- Cardinal Bernardin Cancer Center at Loyola University Medical Center
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
- Case Comprehensive Cancer Center
- Cleveland Clinic Taussig Cancer Center
- Community Oncology Group at Cleveland Clinic Cancer Center
- Cleveland Clinic - Wooster
- Brooke Army Medical Center
- Wilford Hall Medical Center
- University of Texas Health Science Center at San Antonio
- St. Joseph Hospital Community Cancer Center
- Olympic Hematology and Oncology
- Skagit Valley Hospital Cancer Care Center
- Group Health Central Hospital
- Fred Hutchinson Cancer Research Center
- Harborview Medical Center
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
- University Cancer Center at University of Washington Medical Center
- North Puget Oncology at United General Hospital
- Cancer Care Northwest - Spokane South
- Wenatchee Valley Medical Center
Arms of the Study
Arm 1
Experimental
treatment
Single-arm, dose-escalation of BMS-247550