jvrs-100 for the treatment of patients with relapsed or refractory leukemia

Conditions: Leukemia

Summary: this is a phase 1, open-label, dose escalation study of jvrs-100. the study will proceed in 2 stages to minimize the number of patients treated at doses substantially below the recommended phase 2 dose. in stage 1, an accelerated titration schema will be followed with one patient at each dose level. stage 2 will commence after a dose limiting toxicity is observed in stage 1 or after the maximum dose for stage 1 is reached. stage 2 will follow a modified fibonacci schema with 3-6 subjects at each dose level until a recommended phase 2 dose is determined. the cohort will then be expanded to a maximum of 12 patients to more fully evaluate the recommended phase 2 dose.

this is a phase 1, open-label, dose escalation study of jvrs-100. the study will proceed in 2 stages to minimize the number of patients treated at doses substantially below the recommended phase 2 dose. in stage 1, cohorts of three will be treated at each dose level however doses will be doubled from level to level. stage 2 will commence after a dose limiting toxicity is observed in stage 1 or after the maximum dose for stage 1 is reached. stage 2 will follow a modified fibonacci schema with 3-6 subjects at each dose level until a recommended phase 2 dose is determined. the cohort will then be expanded to a maximum of 12 patients to more fully evaluate the recommended phase 2 dose. the principal investigator will assign dose level to be administered to all patients.

Eligibility criteria:
inclusion criteria: * 18 years of age * histologically or cytologically documented relapsed or refractory acute leukemia * unlikely to benefit from standard therapy in the opinion of the investigator or refuse standard therapy * ecog performance status 0-2 * adequate renal and hepatic function * no hematologic criteria for wbc, hbg or platelets * negative virology screen for hiv, hepatitis b surface antigen \& hepatitis c * female patients of childbearing potential must have a negative serum pregnancy test * male \& female patients must agree to use a medically acceptable barrier and/or chemical contraceptive method during the study and for a minimum of 3 months afte the last dose of study treatment. * patients post blood or marrow transplant should demonstrate a circulating cd8 count of at lest 200 cells/ul exclusion criteria: * active cns leukemia * current concomitant chemotherapy, radiation therapy or immunotherapy * receipt of any investigational agent within 28 days of first dose of jvrs-100 * persistent clinically significant toxicity from prior anticancer therapy that is \> grade 2 (nci ctcae v3.0) * bone marrow or stem cell transplant within 3 months prior to first dose of jvrs-100 * chronic administration of immunosuppressive agents within 14 days of first dose of jvrs-100. use of inhaled steroids, nasal sprays, eye drops, and topical creams for small body areas is allowed. * pregnant or lactating * history of prior malignancy other than leukemia within the past 5 years, excluding basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix * patients with a systemic fungal, bacterial, viral, or other infection not controlled * any condition which, in the opinion of the investigator, would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results

Keywords: relapsed leukemia refractory leukemia