Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00093821
Status:
COMPLETED
Last Update Posted:
2013-06-04
First Post:
2004-10-06
Brief Title:
Tanespimycin in Treating Young Patients With Recurrent or Refractory Leukemia or Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Multicenter Phase I Trial of 17-N-allylamino-17-demethoxy Geldanamycin 17-AAG NSC 330507 in Patients With RecurrentRefractory Pediatric Solid Tumors Ewings Sarcoma Desmoplastic Small Round Cell Tumor Osteosarcoma Neuroblastoma and Rhabdomyosarcoma and Leukemia
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01CA069856 | NIH | None | httpsreporternihgovquickSearchU01CA069856 |
| 04-069 | None | None | None |
| POETIC-MSKCC-04069 | None | None | None |
| CDR0000391010 | None | None | None |
| NCI-6323 | None | None | None |
| MSKCC-04069 | None | None | None |