Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00087204
Status:
COMPLETED
Last Update Posted:
2013-01-23
First Post:
2004-07-08
Brief Title:
Rebeccamycin Analog in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia Myelodysplastic Syndrome Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study Of XL119 In Patients With Relapsed Or Refractory Acute Myeloid Leukemia Myelodysplastic Syndromes Acute Lymphocytic Leukemia Or Chronic Myeloid Leukemia In Blastic-Phase
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:
This phase I trial is studying the side effects and best dose of rebeccamycin analog in treating patients with relapsed or refractory acute myeloid leukemia myelodysplastic syndrome acute lymphoblastic leukemia or chronic myelogenous leukemia in blast phase Drugs used in chemotherapy such as rebeccamycin analog 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 and dose-limiting toxicity of rebeccamycin analogue XL119 in patients with relapsed or refractory acute myeloid leukemia myelodysplastic syndromes acute lymphoblastic leukemia or chronic myelogenous leukemia in blastic phase
OUTLINE This is a dose-escalation study
Patients receive rebeccamycin analogue XL119 IV over 1 hour on days 1-5 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients achieving a complete response CR receive 1 additional course beyond CR Patients achieving a partial response PR or hematologic improvement HI receive 2 additional courses beyond PR or HI Cohorts of 3-6 patients receive escalating doses of XL119 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
I Determine the maximum tolerated dose and dose-limiting toxicity of rebeccamycin analogue XL119 in patients with relapsed or refractory acute myeloid leukemia myelodysplastic syndromes acute lymphoblastic leukemia or chronic myelogenous leukemia in blastic phase
OUTLINE This is a dose-escalation study
Patients receive rebeccamycin analogue XL119 IV over 1 hour on days 1-5 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients achieving a complete response CR receive 1 additional course beyond CR Patients achieving a partial response PR or hematologic improvement HI receive 2 additional courses beyond PR or HI Cohorts of 3-6 patients receive escalating doses of XL119 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
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 |
|---|---|---|---|
| MDA-2003-0909 | None | None | None |
| U01CA062461 | NIH | None | None |
| CDR0000373813 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU01CA062461 |