Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006364
Status:
COMPLETED
Last Update Posted:
2013-01-23
First Post:
2000-10-04
Brief Title:
Homoharringtonine in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I and Pilot Study of Subcutaneous Homoharringtonine in Chronic Myelogenous Leukemia
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Phase II trial to study the effectiveness of homoharringtonine in treating patients who have chronic phase chronic myelogenous leukemia Drugs used in chemotherapy such as homoharringtonine work in different ways to stop cancer cells from dividing so they stop growing or die
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated dose of homoharringtonine in patients with transformed phases of chronic myelogenous leukemia CML Phase I completed as of 2112004 II Determine the toxicity profile of this drug in these patients III Determine the response duration in patients with chronic phase CML treated with this drug
IV Compare the pharmacokinetics of this drug administered as a continuous infusion vs subcutaneously in these patients
OUTLINE This is a pilot dose-escalation study Phase I completed as of 2112004
Remission induction therapy Patients receive remission induction therapy comprising homoharringtonine IV continuously over 24 hours on day 1 and then subcutaneously SC twice daily on days 2-14 for course 1 Subsequent courses of remission induction therapy comprise homoharringtonine SC twice daily on days 1-14 Treatment continues monthly for at least 2 courses
Maintenance therapy Patients with complete hematologic remission receive maintenance therapy comprising homoharringtonine SC twice daily on days 1-7 monthly for 3 years in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of homoharringtonine until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity An additional cohort of 25-30 patients with chronic phase chronic myelogenous leukemia receives remission induction and maintenance therapy as above at the MTD Phase I completed as of 2112004
Patients are followed every 3 months
PROJECTED ACCRUAL A maximum of 50 patients will be accrued for this study
I Determine the maximum tolerated dose of homoharringtonine in patients with transformed phases of chronic myelogenous leukemia CML Phase I completed as of 2112004 II Determine the toxicity profile of this drug in these patients III Determine the response duration in patients with chronic phase CML treated with this drug
IV Compare the pharmacokinetics of this drug administered as a continuous infusion vs subcutaneously in these patients
OUTLINE This is a pilot dose-escalation study Phase I completed as of 2112004
Remission induction therapy Patients receive remission induction therapy comprising homoharringtonine IV continuously over 24 hours on day 1 and then subcutaneously SC twice daily on days 2-14 for course 1 Subsequent courses of remission induction therapy comprise homoharringtonine SC twice daily on days 1-14 Treatment continues monthly for at least 2 courses
Maintenance therapy Patients with complete hematologic remission receive maintenance therapy comprising homoharringtonine SC twice daily on days 1-7 monthly for 3 years in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of homoharringtonine until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity An additional cohort of 25-30 patients with chronic phase chronic myelogenous leukemia receives remission induction and maintenance therapy as above at the MTD Phase I completed as of 2112004
Patients are followed every 3 months
PROJECTED ACCRUAL A maximum of 50 patients will be accrued for this study
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 |
|---|---|---|---|
| ID 99-032 | None | None | None |
| N01CM17003 | NIH | None | None |
| CDR0000068237 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchN01CM17003 |