Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00084916
Status:
COMPLETED
Last Update Posted:
2013-01-23
First Post:
2004-06-10
Brief Title:
CCI-779 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Myelodysplastic Syndromes or Chronic Myelogenous Leukemia in Blastic Phase
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study Of CCI-779 In Patients With Relapsed Or Refractory Acute Myeloid Leukemia 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:
Drugs used in chemotherapy such as CCI-779 work in different ways to stop cancer cells from dividing so they stop growing or die This phase II trial is studying how well CCI-779 works in treating patients with relapsed or refractory acute myeloid leukemia acute lymphoblastic leukemia myelodysplastic syndrome or chronic myelogenous leukemia in blastic phase
Detailed Description:
PRIMARY OBJECTIVES
I Determine the activity of CCI-779 in patients with relapsed or refractory acute myeloid leukemia acute lymphoblastic leukemia myelodysplastic syndromes or chronic myelogenous leukemia in blastic phase
II Correlate the effect of this drug with altered mitochondrial respiration in the leukemia cells of these patients
OUTLINE Patients are stratified according to disease acute myeloid leukemia myelodysplastic syndromes chronic myelogenous leukemia in blastic phase CML-BP non-lymphoid vs acute lymphoblastic leukemia CML-BP lymphoid
Patients receive CCI-779 IV over 30 minutes on days 1 8 15 and 22 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months
PROJECTED ACCRUAL A total of 24-74 patients 12-37 per stratum will be accrued for this study within 8-46 months
I Determine the activity of CCI-779 in patients with relapsed or refractory acute myeloid leukemia acute lymphoblastic leukemia myelodysplastic syndromes or chronic myelogenous leukemia in blastic phase
II Correlate the effect of this drug with altered mitochondrial respiration in the leukemia cells of these patients
OUTLINE Patients are stratified according to disease acute myeloid leukemia myelodysplastic syndromes chronic myelogenous leukemia in blastic phase CML-BP non-lymphoid vs acute lymphoblastic leukemia CML-BP lymphoid
Patients receive CCI-779 IV over 30 minutes on days 1 8 15 and 22 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months
PROJECTED ACCRUAL A total of 24-74 patients 12-37 per stratum will be accrued for this study within 8-46 months
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 |
|---|---|---|---|
| CDR0000367093 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchN01CM62202 |
| MDA-2003-0830 | None | None | None |
| N01CM62202 | NIH | None | None |