Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00100997
Status:
COMPLETED
Last Update Posted:
2013-07-10
First Post:
2005-01-07
Brief Title:
17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Did Not Respond to Imatinib Mesylate
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 1 Multicenter Open-Label Dose-Escalation Safety Pharmacokinetic and Pharmacodynamic Study of Intravenously Administered CNF1010 17-Allylamino-17-Demethoxygeldanamycin 17-AAG in Patients With Gleevec-Resistent Chronic Myelogenous Leukemia
Status:
COMPLETED
Status Verified Date:
2005-05
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:
RATIONALE Drugs used in chemotherapy such as 17-N-allylamino-17-demethoxygeldanamycin work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing It may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth
PURPOSE This phase I trial is studying the side effects and best dose of 17-N-allylamino-17-demethoxygeldanamycin in treating patients with chronic phase chronic myelogenous leukemia that did not respond to imatinib mesylate
PURPOSE This phase I trial is studying the side effects and best dose of 17-N-allylamino-17-demethoxygeldanamycin in treating patients with chronic phase chronic myelogenous leukemia that did not respond to imatinib mesylate
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose and dose-limiting toxicity of 17-N-allylamino-17-demethoxygeldanamycin 17-AAG in terms of frequency severity and duration of treatment-emergent adverse events in patients with imatinib mesylate-resistant Philadelphia chromosome Ph-positive chronic phase chronic myelogenous leukemia
Determine the pharmacokinetics of this drug and its primary metabolite 17-amino-17-demethoxygeldanamycin in these patients
Secondary
Determine the hematologic response rate in terms of WBC count platelet count and assessment of blast cells in peripheral blood in patients treated with this drug
Determine the cytogenic response rate in terms of Ph-positive progenitor cells in the bone marrow in patients treated with this drug
Assess the effect of this drug on pharmacodynamic markers ie CRKL phosphorylation BCR-ABL kinase activity and BCR-ABL RAF kinase and HSP70 expression in these patients
OUTLINE This is an open label dose-escalation multicenter study
Patients receive 17-N-allylamino-17-demethoxygeldanamycin 17-AAG IV over 15 minutes or 1 hour depending on the dose administered once on days 1 4 8 11 15 18 22 and 25 Treatment repeats every 28 days for up to 3 courses in the absence of unacceptable toxicity or disease progression Eligible patients may receive additional courses of 17-AAG at the discretion of the investigator
Cohorts of 3-6 patients receive escalating doses of 17-AAG 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 Up to 10 additional patients are treated at the MTD
Patients are followed for 1 month
PROJECTED ACCRUAL Approximately 40 patients will be accrued for this study
Primary
Determine the maximum tolerated dose and dose-limiting toxicity of 17-N-allylamino-17-demethoxygeldanamycin 17-AAG in terms of frequency severity and duration of treatment-emergent adverse events in patients with imatinib mesylate-resistant Philadelphia chromosome Ph-positive chronic phase chronic myelogenous leukemia
Determine the pharmacokinetics of this drug and its primary metabolite 17-amino-17-demethoxygeldanamycin in these patients
Secondary
Determine the hematologic response rate in terms of WBC count platelet count and assessment of blast cells in peripheral blood in patients treated with this drug
Determine the cytogenic response rate in terms of Ph-positive progenitor cells in the bone marrow in patients treated with this drug
Assess the effect of this drug on pharmacodynamic markers ie CRKL phosphorylation BCR-ABL kinase activity and BCR-ABL RAF kinase and HSP70 expression in these patients
OUTLINE This is an open label dose-escalation multicenter study
Patients receive 17-N-allylamino-17-demethoxygeldanamycin 17-AAG IV over 15 minutes or 1 hour depending on the dose administered once on days 1 4 8 11 15 18 22 and 25 Treatment repeats every 28 days for up to 3 courses in the absence of unacceptable toxicity or disease progression Eligible patients may receive additional courses of 17-AAG at the discretion of the investigator
Cohorts of 3-6 patients receive escalating doses of 17-AAG 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 Up to 10 additional patients are treated at the MTD
Patients are followed for 1 month
PROJECTED ACCRUAL Approximately 40 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000407499 | REGISTRY | None | None |
| CTC-CNF1010 | None | None | None |
| CTC-CNF1010-CML-04001 | Registry Identifier | PDQ Physician Data Query | None |