penclomedine in treating patients with solid tumors or lymphoma

Conditions: Lymphoma; Unspecified Adult Solid Tumor, Protocol Specific

Summary: phase i trial to study the effectiveness of penclomedine in treating patients with malignant solid tumors or lymphomas. drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

objectives: i. determine the maximum tolerated dose (mtd) and phase ii dose of oral penclomedine in patients with malignancies. ii. determine the toxic effects of oral penclomedine in these patients. iii. determine the pharmacokinetics of oral penclomedine in these patients. iv. determine the bioavailability of oral penclomedine in these patients. outline: patients enrolled on the bioavailability portion of this study receive one dose of iv penclomedine over 1 hour followed by 2 weeks of rest. at the end of two weeks, they receive oral penclomedine for 5 days every 28 days. the starting dose is determined by a single primary patient who has been administered oral penclomedine and observed for dose limiting toxicity (dlt). \[bioavailability portion completed as of 3/98.\] those not on the bioavailability portion of study start on a standard design dose escalating schedule in which patients enroll in cohorts of 3. patients are administered oral penclomedine daily for 5 days. this treatment repeats every 4 weeks. the mtd is defined as the dose immediately below that at which 2 patients experience dlt. treatment repeats for 6 courses or until severe toxicity or tumor progression is observed.

Eligibility criteria:
disease characteristics: * histologically confirmed malignancy (solid tumor or lymphoma) * no history of brain metastases patient characteristics: * age: 18 and over * life expectancy: at least 12 weeks * performance status: ecog 0-2 * wbc at least 4,000/mm3 * absolute neutrophil count at least 1,500/mm3 * platelet count at least 100,000/mm3 * bilirubin less than 1.5 mg/dl * creatinine normal * no history of seizure disorder not pregnant or nursing prior concurrent therapy: * at least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas and mitomycin) and recovered * at least 4 weeks since prior radiotherapy and recovered

Keywords: stage i adult hodgkin lymphoma stage ii adult hodgkin lymphoma stage iii adult hodgkin lymphoma stage iv adult hodgkin lymphoma recurrent adult hodgkin lymphoma unspecified adult solid tumor, protocol specific stage i grade 1 follicular lymphoma stage i grade 2 follicular lymphoma stage i grade 3 follicular lymphoma stage i adult diffuse small cleaved cell lymphoma stage i adult diffuse mixed cell lymphoma stage i adult diffuse large cell lymphoma stage i adult immunoblastic large cell lymphoma stage i adult lymphoblastic lymphoma stage i adult burkitt lymphoma stage iii grade 1 follicular lymphoma stage iii grade 2 follicular lymphoma stage iii grade 3 follicular lymphoma stage iii adult diffuse small cleaved cell lymphoma stage iii adult diffuse mixed cell lymphoma stage iii adult diffuse large cell lymphoma stage iii adult immunoblastic large cell lymphoma stage iii adult lymphoblastic lymphoma stage iii adult burkitt lymphoma 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 i adult t-cell leukemia/lymphoma stage ii adult t-cell leukemia/lymphoma stage iii adult t-cell leukemia/lymphoma stage iv adult t-cell leukemia/lymphoma recurrent adult t-cell leukemia/lymphoma aids-related peripheral/systemic lymphoma aids-related primary cns lymphoma stage i mantle cell lymphoma contiguous stage ii grade 1 follicular lymphoma contiguous stage ii grade 2 follicular lymphoma contiguous stage ii grade 3 follicular lymphoma contiguous stage ii adult diffuse small cleaved cell lymphoma contiguous stage ii mantle cell lymphoma contiguous stage ii adult diffuse mixed cell lymphoma contiguous stage ii adult immunoblastic large cell lymphoma contiguous stage ii adult diffuse large cell lymphoma contiguous stage ii adult burkitt lymphoma contiguous stage ii adult lymphoblastic lymphoma noncontiguous stage ii grade 1 follicular lymphoma noncontiguous stage ii grade 2 follicular lymphoma noncontiguous stage ii grade 3 follicular lymphoma noncontiguous stage ii adult diffuse small cleaved cell lymphoma noncontiguous stage ii mantle cell lymphoma noncontiguous stage ii adult diffuse mixed cell lymphoma noncontiguous stage ii adult immunoblastic large cell lymphoma noncontiguous stage ii adult diffuse large cell lymphoma noncontiguous stage ii adult burkitt lymphoma noncontiguous stage ii adult lymphoblastic lymphoma stage iii mantle cell lymphoma stage iv mantle cell lymphoma recurrent mantle cell lymphoma angioimmunoblastic t-cell lymphoma anaplastic large cell lymphoma noncontiguous stage ii small lymphocytic lymphoma noncontiguous stage ii marginal zone lymphoma recurrent marginal zone lymphoma recurrent small lymphocytic lymphoma stage i marginal zone lymphoma stage i small lymphocytic lymphoma stage iii small lymphocytic lymphoma stage iii marginal zone lymphoma stage iv small lymphocytic lymphoma stage iv marginal zone lymphoma contiguous stage ii marginal zone lymphoma contiguous stage ii small lymphocytic lymphoma extranodal marginal zone b-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone b-cell lymphoma splenic marginal zone lymphoma