Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00039117
Status:
COMPLETED
Last Update Posted:
2015-12-04
First Post:
2002-06-06
Brief Title:
Oblimersen Cytarabine and Daunorubicin in Treating Older Patients With Acute Myeloid Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of G3139 NSC 683428 in Combination With Cytarabine and Daunorubicin in Previously Untreated Patients With Acute Myeloid Leukemia AMLgt 60 Years of Age
Status:
COMPLETED
Status Verified Date:
2013-06
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 I trial to study the effectiveness of combining oblimersen with cytarabine and daunorubicin in treating older patients who have previously untreated acute myeloid leukemia Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Oblimersen may help cytarabine and daunorubicin kill more cancer cells by making them more sensitive to chemotherapy
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated dose of daunorubicin in combination with cytarabine and oblimersen in older patients with previously untreated acute myeloid leukemia
II Determine the qualitative and quantitative toxic effects of this regimen in these patients
III Determine the pharmacokinetics of oblimersen in this regimen in these patients
IV Determine the disease-free survival and overall survival of patients treated with this regimen
V Assess the spontaneous rate of apoptosis in leukemic blasts in patients before and after initiation of treatment with oblimersen
VI Determine therapeutic response complete remission in patients treated with this regimen
OUTLINE This is a dose-escalation study of daunorubicin Patients are stratified according to disease status primary vs secondary
INDUCTION THERAPY Patients receive oblimersen G3139 IV continuously on days 1-10 and cytarabine IV continuously on days 4-10 Patients also receive daunorubicin IV daily on days 4-6
Patients with bone marrow cellularity of at least 20 and at least 5 leukemic blasts at day 17 or evidence of refractory disease receive a second induction comprising G3139 IV continuously on days 1-8 cytarabine IV continuously on days 4-8 and daunorubicin IV on days 4-5
CONSOLIDATION THERAPY Beginning no sooner than 14 days after hematologic recovery from induction therapy patients receive G3139 IV continuously on days 1-8 and cytarabine IV over 4 hours on days 4-8 Patients receive a second course of consolidation therapy no sooner than 14 days after hematologic recovery from the first course
Cohorts of 3-6 patients receive escalating doses of daunorubicin 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
Patients are followed every 2 months for 2 years
I Determine the maximum tolerated dose of daunorubicin in combination with cytarabine and oblimersen in older patients with previously untreated acute myeloid leukemia
II Determine the qualitative and quantitative toxic effects of this regimen in these patients
III Determine the pharmacokinetics of oblimersen in this regimen in these patients
IV Determine the disease-free survival and overall survival of patients treated with this regimen
V Assess the spontaneous rate of apoptosis in leukemic blasts in patients before and after initiation of treatment with oblimersen
VI Determine therapeutic response complete remission in patients treated with this regimen
OUTLINE This is a dose-escalation study of daunorubicin Patients are stratified according to disease status primary vs secondary
INDUCTION THERAPY Patients receive oblimersen G3139 IV continuously on days 1-10 and cytarabine IV continuously on days 4-10 Patients also receive daunorubicin IV daily on days 4-6
Patients with bone marrow cellularity of at least 20 and at least 5 leukemic blasts at day 17 or evidence of refractory disease receive a second induction comprising G3139 IV continuously on days 1-8 cytarabine IV continuously on days 4-8 and daunorubicin IV on days 4-5
CONSOLIDATION THERAPY Beginning no sooner than 14 days after hematologic recovery from induction therapy patients receive G3139 IV continuously on days 1-8 and cytarabine IV over 4 hours on days 4-8 Patients receive a second course of consolidation therapy no sooner than 14 days after hematologic recovery from the first course
Cohorts of 3-6 patients receive escalating doses of daunorubicin 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
Patients are followed every 2 months for 2 years
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 |
|---|---|---|---|
| U01CA076576 | NIH | None | httpsreporternihgovquickSearchU01CA076576 |
| OSU-0164 | None | None | None |
| NCI-4630 | None | None | None |
| CDR0000069353 | None | None | None |