sta-5312 administered on alternate weekdays every two weeks to patients with hematologic malignancies and patients with solid tumors

Conditions: Hematological Malignancies; Leukemia; Lymphoma; Metastatic or Unresectable Solid Tumors

Summary: the purpose of this study is to determine the safety, toxicity and patient tolerance of sta-5312 administered intravenously to patients with relapsed or refractory hematological malignancies and patients with solid tumors.


Eligibility criteria:
inclusion criteria: * male and female patients 18 years or older with one of the following malignancies: * histologically or cytologically confirmed hematological malignancy (other than acute myeloid leukemia and myelodysplastic syndrome) and if treatment is medically indicated, or, * histologically-confirmed non-hematological malignancy that is metastatic or unresectable and for which no standard therapy is available. * patients with cll, pll, cml, ctcl, atl, and non-hodgkin's lymphoma may be entered if they are refractory to or have relapsed following conventional chemotherapy regimens such as alkylating agents (e.g. chlorambucil and cyclophosphamide), anthracycline combinations \[e.g. chop (cyclophosphamide, doxorubicin, vincristine, prednisone)\], and/or purine analogues (e.g. fludarabine monophosphate and 2-cda) and are not currently being considered for re-treatment with conventional regimens * patients with cll and other leukemic malignancies will be staged according to the modified rai staging criteria \[low-risk, intermediate-risk and high risk\]. all patients in the high-risk group (stage iii and iv) are eligible. intermediate risk patients (stage i and ii) with one or more criteria of active disease (such as progressive lymphocytosis, lymphadenopathy, and splenomegaly, weight loss \> 10% within 6 months, extreme fatigue, fever and/or night sweats without evidence of infection, etc.) are also eligible * ecog performance status of 0-2 * life expectancy of greater than 12 weeks. * patients must have acceptable organ and marrow function at screening and pre-dose visits as defined below unless approved medically by the clinical investigator. * absolute neutrophils count greater than 1,000 cells/ul for patients with hematologic malignancies and ≥1,500 cells/ul for patients with solid tumors * platelets greater than 100,000/ul * hgb greater than 8.5 g/dl * total bilirubin must be \<1.5 mg/dl or \< 2x upper limit of normal * ast (sgot) \< 2.5 times the upper limit of normal * alt (sgpt) \< 2.5 times the upper limit of normal * adequate renal function (serum creatinine \< 2.0 mg/dl or a calculated creatinine clearance greater than 50 ml/min) * electrocardiogram without evidence of clinically significant conduction abnormalities or active ischemia as determined by the investigator. * nci grade 0-1 left ventricular ejection fraction within 30 days of dosing. * the effects of sta-5312 on the developing human fetus are unknown. therefore, women of childbearing potential (defined as women under 50 years of age or history of amenorrhea for \< 12 months prior to study entry) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. should a female patient become pregnant or suspect she is pregnant while participating in this study, she should inform the treating physician immediately. * ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * women who are pregnant or lactating. * patients who have had chemotherapy, radiotherapy (except palliative radiation delivered to \ 10 mg/day of prednisone or equivalent) within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. * the use of nitrosoureas or mitomycin c within 6 weeks prior to study entry. * patients with prior peripheral blood stem cell rescue or bone marrow transplantation. * history of primary brain tumors or active brain metastases. (patients with previously treated brain metastases who are not receiving corticosteroids or anticonvulsants may be considered for enrollment) * history of stroke or other significant neurologic limitations within 6 months prior to study enrollment * use of any investigational agents within 4 weeks of study enrollment. * history of severe allergic reactions to excipients (e.g. tween 80) or had hypersensitivity reactions to other chemotherapeutic agents similar in structure to sta-5312. * uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, as determined by the investigator. * history of active cns-lymphoma, aids-related lymphoma, or any uncontrolled severe medical illness or infection. * grade 2 or higher sensory or motor neuropathy at screening. * major surgery (excluding that for diagnosis) within 4 weeks of enrollment.

Keywords: hematological malignancies leukemia lymphoma metastatic unresectable solid tumors