Recurrent Childhood Acute Lymphoblastic Leukemia Clinical Trial
Official title:
A Multicenter Phase I Trial of 17-N-allylamino-17-demethoxy Geldanamycin (17-AAG, NSC #330507) in Patients With Recurrent/Refractory Pediatric Solid Tumors (Ewing's Sarcoma, Desmoplastic Small Round Cell Tumor, Osteosarcoma, Neuroblastoma, and Rhabdomyosarcoma) and Leukemia
This phase I trial is studying the side effects and best dose of tanespimycin in treating young patients with recurrent or refractory leukemia or selected solid tumors. Drugs used in chemotherapy, such as tanespimycin, work in different ways to stop cancer cells from dividing so they stop growing or die.
PRIMARY OBJECTIVES:
I. Determine the dose-limiting toxicity and maximum tolerated dose (MTD) of
17-N-allylamino-17-demethoxygeldanamycin (17-AAG) in pediatric patients with recurrent or
refractory leukemia or selected solid tumors.
II. Determine the levels of key proteins known to influence cancer cell survival and
proliferation in patients treated with this drug at the MTD.
SECONDARY OBJECTIVES:
I. Determine the pharmacokinetics of this drug in these patients. II. Evaluate effects of
genetic polymorphisms known to alter the activity of enzymes involved in the metabolism of
this drug.
III. Correlate the alteration of fludeoxyglucose F18 accumulation with tumor response in
patients treated with this drug.
OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to
diagnosis (leukemia vs solid tumor).
Patients receive tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11 (for patients with
solid tumors) OR days 1, 4, 8, 11, 15, and 18 (for patients with leukemia). Courses for all
patients repeat every 21 days in the absence of disease progression or unacceptable
toxicity.
Cohorts of 3-6 patients receive escalating doses of tanespimycin until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity. At least 15 patients are treated at the
MTD.
Patients are followed for 30 days.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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