Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00098423
Status:
COMPLETED
Last Update Posted:
2013-09-30
First Post:
2004-12-07
Brief Title:
Tanespimycin and Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Chronic Myelogenous Leukemia Chronic Myelomonocytic Leukemia or Myelodysplastic Syndromes
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I And Pharmacological Trial Of 17-Allylamino -17-demethoxygeldanamycin 17-AAG And Cytarabine In Refractory Leukemia And Myelodysplastic Syndrome
Status:
COMPLETED
Status Verified Date:
2013-09
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 when given with cytarabine in treating patients with relapsed or refractory acute myeloid leukemia acute lymphoblastic leukemia chronic myelogenous leukemia chronic myelomonocytic leukemia or myelodysplastic syndromes Drugs used in chemotherapy such as tanespimycin and cytarabine work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Tanespimycin may also help cytarabine kill more cancer cells by making cancer cells more sensitive to the drug Giving tanespimycin together with cytarabine may kill more cancer cells
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated dose of 17-N-allylamino-17-demethoxygeldanamycin 17-AAG tanespimycin when administered with cytarabine in patients with relapsed or refractory acute myeloid leukemia acute lymphoblastic leukemia chronic myelogenous leukemia chronic myelomonocytic leukemia or high-grade myelodysplastic syndromes
II Determine the toxic effects of this regimen in these patients III Determine preliminarily the activity of this regimen in these patients IV Correlate the pharmacokinetics of this regimen with cytochrome p450 3A5 genotype in these patients
V Determine the effect of this regimen on client proteins in vivo and ex vivo using leukemic blasts from patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of tanespimycin
Patients receive induction therapy comprising cytarabine intravenously IV continuously on days 1-5 and tanespimycin IV over 1 hour on days 3 and 6
Patients achieving a morphologic complete response with incomplete blood count recovery CRi or partial response may be eligible to receive a second induction course of therapy after day 21 at the discretion of the principal investigator Patients achieving a complete response CR receive up to 4 courses of consolidation therapy with cytarabine and tanespimycin Consolidation therapy repeats approximately every 60 days in the absence of disease progression or unacceptable toxicity Patients who achieve CR and remain in remission for 6 months may be retreated with cytarabine and tanespimycin at the current dose level or the maximum tolerated dose MTD at the time of relapse Cohorts of 3-6 patients receive escalating doses of tanespimycin until the 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 Patients are followed at 3 months
I Determine the maximum tolerated dose of 17-N-allylamino-17-demethoxygeldanamycin 17-AAG tanespimycin when administered with cytarabine in patients with relapsed or refractory acute myeloid leukemia acute lymphoblastic leukemia chronic myelogenous leukemia chronic myelomonocytic leukemia or high-grade myelodysplastic syndromes
II Determine the toxic effects of this regimen in these patients III Determine preliminarily the activity of this regimen in these patients IV Correlate the pharmacokinetics of this regimen with cytochrome p450 3A5 genotype in these patients
V Determine the effect of this regimen on client proteins in vivo and ex vivo using leukemic blasts from patients treated with this regimen
OUTLINE This is a multicenter dose-escalation study of tanespimycin
Patients receive induction therapy comprising cytarabine intravenously IV continuously on days 1-5 and tanespimycin IV over 1 hour on days 3 and 6
Patients achieving a morphologic complete response with incomplete blood count recovery CRi or partial response may be eligible to receive a second induction course of therapy after day 21 at the discretion of the principal investigator Patients achieving a complete response CR receive up to 4 courses of consolidation therapy with cytarabine and tanespimycin Consolidation therapy repeats approximately every 60 days in the absence of disease progression or unacceptable toxicity Patients who achieve CR and remain in remission for 6 months may be retreated with cytarabine and tanespimycin at the current dose level or the maximum tolerated dose MTD at the time of relapse Cohorts of 3-6 patients receive escalating doses of tanespimycin until the 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 Patients are followed at 3 months
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 |
|---|---|---|---|
| U01CA069912 | NIH | CTEP | httpsreporternihgovquickSearchU01CA069912 |
| NCI-2009-00056 | REGISTRY | None | None |
| NCI-6383 | None | None | None |
| CDR0000401509 | None | None | None |
| MC0313 | OTHER | None | None |
| 6383 | OTHER | None | None |
| U01CA070095 | NIH | None | None |