Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005942
Status:
COMPLETED
Last Update Posted:
2013-01-23
First Post:
2000-07-05
Brief Title:
Liposomal Daunorubicin and SU5416 in Treating Patients With Hematologic Cancer That Has Not Responded to Initial Therapy
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial of Liposomal Daunorubicin Daunoxome and SU5416 NSC 696819 in Patients With AML RAEB RAEB-T or CMML in Transformation Refractory to One Course of Induction Chemotherapy
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 III trial to study the effectiveness of liposomal daunorubicin and SU5416 in treating patients who have hematologic cancer that has not responded to initial therapy Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die SU5416 may stop the growth of hematologic cancer by stopping blood flow to the cancer
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated dose of SU5416 when administered with daunorubicin liposomal in patients with acute myeloid leukemia refractory anemia with excess blasts RAEB RAEB in transformation or chronic myelomonocytic leukemia not in complete remission 21-50 days after one course of induction chemotherapy
II Determine the efficacy of this regimen in these patients III Determine the qualitative and quantitative toxicities of this regimen in these patients
OUTLINE This is a dose escalation study of SU5416
Patients receive daunorubicin liposomal IV over 6 hours on days 1-3 and SU5416 IV twice a week for 2 months The second course is administered for 1 month then treatment continues every 4-6 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of SU5416 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 12-37 patients will be accrued for this study within 1 year
I Determine the maximum tolerated dose of SU5416 when administered with daunorubicin liposomal in patients with acute myeloid leukemia refractory anemia with excess blasts RAEB RAEB in transformation or chronic myelomonocytic leukemia not in complete remission 21-50 days after one course of induction chemotherapy
II Determine the efficacy of this regimen in these patients III Determine the qualitative and quantitative toxicities of this regimen in these patients
OUTLINE This is a dose escalation study of SU5416
Patients receive daunorubicin liposomal IV over 6 hours on days 1-3 and SU5416 IV twice a week for 2 months The second course is administered for 1 month then treatment continues every 4-6 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of SU5416 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 12-37 patients will be accrued for this study within 1 year
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 |
|---|---|---|---|
| ID99-341 | None | None | None |
| CDR0000067822 | REGISTRY | PDQ Physician Data Query | None |