BMS-247550 in Treating Patients With Advanced Cancers
Lymphoma, Small Intestine Cancer, Unspecified Adult Solid Tumor, Protocol Specific
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring stage IV adult Hodgkin lymphoma, recurrent adult Hodgkin lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, small intestine lymphoma, unspecified adult solid tumor, protocol specific, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma, stage IV adult diffuse small cleaved cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult immunoblastic large cell lymphoma, stage IV adult lymphoblastic lymphoma, stage IV adult Burkitt lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent adult Burkitt lymphoma, stage IV adult T-cell leukemia/lymphoma, recurrent adult T-cell leukemia/lymphoma, primary central nervous system non-Hodgkin lymphoma, AIDS-related peripheral/systemic lymphoma, AIDS-related primary CNS lymphoma, intraocular lymphoma, stage IV mantle cell lymphoma, recurrent mantle cell lymphoma, angioimmunoblastic T-cell lymphoma, anaplastic large cell lymphoma, stage IV mycosis fungoides/Sezary syndrome, recurrent mycosis fungoides/Sezary syndrome, 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 mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed malignant solid tumor or lymphoma for which no other potentially curative therapeutic option exists or demonstrates increased survival (considering tumor type, stage, and number of prior regimens) No symptomatic brain metastases requiring dexamethasone No progression or cerebral edema on CT scan or MRI within the past 4 weeks PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Neutrophil count at least 1,500/mm^3 Hemoglobin at least 8.5 g/dL Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No atrial or ventricular arrhythmias requiring medication No ischemic event within the past 6 months Other: No pre-existing peripheral neuropathy greater than grade 1 No other serious medical illness or active infection that would preclude study participation No dementia, psychiatric illness, or other alteration in mental status that would preclude study compliance No other active malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix No history of allergy or hypersensitivity reaction to paclitaxel or other Cremophor EL-containing compound Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 2 months after study completion PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered No other concurrent chemotherapy Endocrine therapy: At least 4 weeks since prior anticancer hormonal therapy and recovered No concurrent hormonal therapy except LHRH agonists for non-castrated prostate cancer, contraceptives, hormone replacement therapy (e.g., conjugated estrogens), or megestrol as an appetite stimulant Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Concurrent palliative radiotherapy to limited sites allowed Surgery: At least 4 weeks since prior surgery and recovered Other: At least 30 days since prior investigational agents and recovered No other concurrent experimental medications No concurrent antiretroviral (HAART) therapy for HIV-positive patients
Sites / Locations
- Cancer Therapy and Research Center
- Veterans Affairs Medical Center - San Antonio (Murphy)
- University of Texas Health Science Center at San Antonio
Arms of the Study
Arm 1
Experimental
Arm I
Patients receive BMS-247550 IV over 1 hour once weekly on weeks 1-4. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of BMS-247550 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at that dose level. Patients treated at the MTD receive treatment once weekly on weeks 1-3 of each 4-week course.