Ignite Creation Date:
2024-05-05 @ 9:53 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004263
Status:
COMPLETED
Last Update Posted:
2012-07-30
First Post:
2000-01-28
Brief Title:
Cytarabine and UCN-01 in Treating Patients With Refractory or Relapsed Acute Myelogenous Leukemia or Myelodysplastic Syndrome
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase I Study of UCN-01 and Cytarabine ARA-C in Patients With Acute Myelogenous Leukemia and Myelodysplastic Syndromes
Status:
COMPLETED
Status Verified Date:
2012-07
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 use different ways to stop cancer cells from dividing so they stop growing or die UCN-01 may make cancer cells more sensitive to cytarabine
PURPOSE Phase I trial to study the effectiveness of cytarabine and UCN-01 in treating patients who have refractory or relapsed acute myelogenous leukemia or myelodysplastic syndrome
PURPOSE Phase I trial to study the effectiveness of cytarabine and UCN-01 in treating patients who have refractory or relapsed acute myelogenous leukemia or myelodysplastic syndrome
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of cytarabine when combined with UCN-01 in patients with refractory or relapsed acute myelogenous leukemia or myelodysplastic syndrome II Determine the dose limiting toxicity pharmacokinetics and pharmacodynamics of this regimen in these patients III Assess the antileukemia effect of this regimen in this patient population
OUTLINE This is a dose escalation multicenter study of cytarabine Patients receive cytarabine IV over 24 hours on days 1-4 of each course Patients receive UCN-01 IV over 24 hours on days 2-4 of course 1 and over 36 hours beginning on day 2 of subsequent courses Treatment repeats every 4 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of cytarabine 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
PROJECTED ACCRUAL A maximum of 30 patients will be accrued for this study
OUTLINE This is a dose escalation multicenter study of cytarabine Patients receive cytarabine IV over 24 hours on days 1-4 of each course Patients receive UCN-01 IV over 24 hours on days 2-4 of course 1 and over 36 hours beginning on day 2 of subsequent courses Treatment repeats every 4 weeks for a maximum of 4 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of cytarabine 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
PROJECTED ACCRUAL A maximum of 30 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 |
|---|---|---|---|
| CDR0000067522 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA016672 |
| U01CA062461 | NIH | None | None |
| P30CA016672 | NIH | None | None |
| MDA-DM-99165 | OTHER | None | None |
| NCI-T99-0100 | None | None | None |