vnp40101m in treating patients with advanced or metastatic cancer

Conditions: Lymphoma; Small Intestine Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. purpose: phase i trial to study the effectiveness of vnp40101m in treating patients who have advanced or metastatic cancer.

objectives: * determine the toxic effects of vnp40101m in patients with advanced or metastatic solid tumor or lymphoma. * determine the maximum tolerated dose of this drug in these patients. * determine the pharmacokinetics of this drug in these patients. * determine the antitumor effects of this drug in these patients. outline: this is a dose-escalation study. patients receive vnp40101m iv over 15 minutes on days 1, 8, and 15. treatment repeats every 28 days. cohorts of 3-6 patients receive escalating doses of vnp40101m until the maximum tolerated dose is determined. projected accrual: approximately 20 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed advanced or metastatic solid tumor or lymphoma for which no curative or standard effective therapy exists * measurable or evaluable disease * primary brain tumors or brain metastases allowed provided neurologic deficits are stable and do not preclude study compliance patient characteristics: age * 18 and over performance status * ecog 0-1 life expectancy * at least 3 months hematopoietic * granulocyte count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 * hematocrit at least 30% (transfusion allowed) * no bleeding diathesis hepatic * pt and ptt no greater than 1.5 times the upper limit of normal (uln) * bilirubin no greater than 1.5 times uln * alt and ast no greater than 1.5 times uln (3 times uln if liver metastases present) * albumin at least 2.5 gm/dl renal * creatinine no greater than 2.0 mg/dl cardiovascular * at least 3 months since prior myocardial infarction * no symptomatic coronary artery disease * no arrhythmias requiring medication * no uncontrolled congestive heart failure pulmonary * no dyspnea on minimal or moderate exertion * dlco and fev1 at least 60% predicted other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no uncontrolled active bleeding (e.g., active peptic ulcer disease) * no active infection * hiv negative prior concurrent therapy: biologic therapy * recovered from acute toxicities of prior biologic therapy (persisting, chronic toxicity allowed if stable and no greater than grade 1) chemotherapy * more than 6 months since prior high-dose chemotherapy with stem cell support * more than 3 weeks since prior cytotoxic chemotherapy (6 weeks for mitomycin or nitrosoureas) * recovered from acute toxicities of prior chemotherapy (persisting, chronic toxicity allowed if stable and no greater than grade 1) endocrine therapy * at least 2 weeks since prior hormonal therapy radiotherapy * recovered from acute toxicities of prior radiotherapy (persisting, chronic toxicity allowed if stable and no greater than grade 1) surgery * at least 2 weeks since prior surgery other * no other concurrent standard or investigational treatment for cancer * no concurrent disulfiram

Keywords: anaplastic large cell lymphoma angioimmunoblastic t-cell lymphoma intraocular lymphoma primary central nervous system non-hodgkin lymphoma recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult burkitt lymphoma recurrent adult hodgkin lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent adult t-cell leukemia/lymphoma recurrent cutaneous t-cell non-hodgkin lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent mantle cell lymphoma recurrent mycosis fungoides/sezary syndrome small intestine lymphoma stage iv adult diffuse large cell lymphoma stage iv adult diffuse mixed cell lymphoma stage iv adult diffuse small cleaved cell lymphoma stage iv adult burkitt lymphoma stage iv adult 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 follicular lymphoma stage iv grade 2 follicular lymphoma stage iv grade 3 follicular lymphoma stage iv mantle cell lymphoma stage iv mycosis fungoides/sezary syndrome unspecified adult solid tumor, protocol specific 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