Clinical Trial: Tanespimycin in Treating Young Patients With Recurrent or Refractory Leukemia or Solid Tumors

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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, Desm

Brief Summary: 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.

Detailed Summary:

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.

Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: MTD, defined as the highest dose level with an observed incidence of DLT in no more than 1 out of 6 patients treated at a particular dose level [ Time Frame: 21 days ]

Original Primary Outcome:

Current Secondary Outcome: Change in Hsp90 client protein levels in relation to dose of tanespimycin [ Time Frame: Baseline to 21 days ]

Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: October 6, 2004
Date Started: September 2004
Date Completion:
Last Updated: June 3, 2013
Last Verified: June 2013