Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016016
Status:
COMPLETED
Last Update Posted:
2013-10-08
First Post:
2001-05-06
Brief Title:
Flavopiridol Cytarabine and Mitoxantrone in Treating Patients With Acute Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Study of Flavopiridol NSC 649890 IND 46211 in Timed Sequential Combination With Cytosine Arabinoside Ara-C and Mitoxantrone for Adults With Poor-Risk Acute Leukemias
Status:
COMPLETED
Status Verified Date:
2013-10
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 combining flavopiridol and cytarabine with mitoxantrone in treating patients who have acute leukemia Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die Combining more than one drug may kill more cancer cells
Detailed Description:
PRIMARY OBJECTIVES
I To determine the toxicities of escalating doses of flavopiridol administered in a timed sequence with ara-C and mitoxantrone in adults with refractory or relapsed acute leukemias or high-risk myelodysplasias MDS
II To determine if flavopiridol administered in a timed sequence with ara-C and Mitoxantrone will induce clinical responses in adults with refractory or relapsed acute leukemias or MDS
III To determine if flavopiridol is directly cytotoxic to leukemic blasts in vivo
IV To determine if flavopiridol can recruit and synchronize residual leukemic blasts to proliferate in vivo
OUTLINE This is a dose-escalation study of flavopiridol Phase I closed to accrual effective10242003
Patients receive flavopiridol IV over 1 hour on days 1-3 and cytarabine IV continuously on days 6-9 followed by mitoxantrone IV over 30-150 minutes on day 9 Patients achieving a partial or complete response after the first course of therapy may receive an additional course of therapy beginning 35 7 days after blood count recovery
Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Phase I closed to accrual effective 10242003 Once the MTD is reached additional patients are accrued to receive flavopiridol at the recommended phase II dose
I To determine the toxicities of escalating doses of flavopiridol administered in a timed sequence with ara-C and mitoxantrone in adults with refractory or relapsed acute leukemias or high-risk myelodysplasias MDS
II To determine if flavopiridol administered in a timed sequence with ara-C and Mitoxantrone will induce clinical responses in adults with refractory or relapsed acute leukemias or MDS
III To determine if flavopiridol is directly cytotoxic to leukemic blasts in vivo
IV To determine if flavopiridol can recruit and synchronize residual leukemic blasts to proliferate in vivo
OUTLINE This is a dose-escalation study of flavopiridol Phase I closed to accrual effective10242003
Patients receive flavopiridol IV over 1 hour on days 1-3 and cytarabine IV continuously on days 6-9 followed by mitoxantrone IV over 30-150 minutes on day 9 Patients achieving a partial or complete response after the first course of therapy may receive an additional course of therapy beginning 35 7 days after blood count recovery
Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Phase I closed to accrual effective 10242003 Once the MTD is reached additional patients are accrued to receive flavopiridol at the recommended phase II dose
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 |
|---|---|---|---|
| NCI-2012-03153 | REGISTRY | None | None |
| MSGCC-0052 | None | None | None |
| NCI-3170 | None | None | None |
| JHOC-J0254 | None | None | None |
| J0254 | OTHER | None | None |
| 3170 | OTHER | None | None |
| U01CA070095 | NIH | None | None |
| U01CA069854 | NIH | CTEP | httpsreporternihgovquickSearchU01CA069854 |