A MULTICENTER PHASE I TRIAL OF 17-N-ALLYLAMINO-17-DEMETHOXY GELDANAMYCIN

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a multicenter Phase I Trial of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG, NSC#330507) in patients with recurrent/refractory pediatric malignancies. The primary objectives of this study are to establish the Dose Limiting Toxicity (DLT) and the Maximum Tolerated Dose (MTD) of 17-AAG in patients with recurrent/refractory pediatric malignancies and to determine the extent to which the 17-AAG, administered at the MTD, alters the levels of key proteins known to influence proliferation and survival in cancer cells collected from patients with pediatric solid tumors and leukemias. Patients must have disease that has progressed despite standard therapy or for which no effective standard therapy is known. Patients will undergo stratification by diagnosis at study entry to either a solid tumor or a leukemia stratum. Strata will be evaluated separately. Patients will be treated with 17-AAG primarily in the outpatient setting, although treatment as an inpatient will be permitted as long as eligibility criteria are met. Drug will be administered intravenously twice per week for 2 weeks followed by a 1 week rest for patients with solid tumors. Based on experience in adult leukemia patients, the rest week will be omitted in patients with leukemia. These patients will be treated twice per week for 3 consecutive weeks.