Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00081133
Status:
COMPLETED
Last Update Posted:
2013-06-05
First Post:
2004-04-07
Brief Title:
Arsenic Trioxide and Imatinib Mesylate in Treating Patients With Accelerated Phase or Blastic Phase Chronic Myelogenous Leukemia or Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Phase III Study to Determine Safety and Efficacy of Arsenic Trioxide Trisneox in Combination With Imatinib STI571 Gleevec in Patients With Chronic Myelogenous Leukemia in Accelerated or Blastic Phase Disease or Ph Acute Lymphoblastic Leukemia
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:
RATIONALE Drugs used in chemotherapy such as arsenic trioxide work in different ways to stop cancer cells from dividing so they stop growing or die Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for their growth Combining arsenic trioxide with imatinib mesylate may kill more cancer cells
PURPOSE This phase III trial is studying the side effects and best dose of arsenic trioxide when given with imatinib mesylate and to see how well they work in treating patients with accelerated phase or blastic phase chronic myelogenous leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia
PURPOSE This phase III trial is studying the side effects and best dose of arsenic trioxide when given with imatinib mesylate and to see how well they work in treating patients with accelerated phase or blastic phase chronic myelogenous leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolererated dose of arsenic trioxide when administered with imatinib mesylate in patients with accelerated or blastic phase chronic myelogenous leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia
Determine the rate of complete morphologic remission in the bone marrow of patients treated with this regimen
OUTLINE This is a phase I dose-escalation study of arsenic trioxide followed by a phase II study
Phase I
Induction therapy Patients receive oral imatinib mesylate once daily on days 1-35 weeks 1-5 and arsenic trioxide IV over 1-4 hours on days 1-5 8-12 15-19 and 22-26 weeks 1-4
Patients undergo bone marrow evaluation on week 5 Patients achieving a morphologic remission proceed to consolidation therapy Patients not achieving morphologic remission receive a second course of imatinib mesylate as above on weeks 6-10 and arsenic trioxide as above on weeks 6-9 Patients are re-evaluated on week 10 Patients achieving morphologic remission proceed to consolidation therapy Patients not achieving a morphologic remission are removed from study
Consolidation therapy Patients receive oral imatinib mesylate as in induction therapy on approximately weeks 6-11 or weeks 11-16 and arsenic trioxide IV over 1-4 hours on days 1 3 5 8 10 12 15 17 19 22 24 and 26 approximately weeks 6-9 OR weeks 11-14
Patients who remain in morphologic remission receive a second course of imatinib mesylate as in induction therapy on approximately weeks 12-17 or weeks 17-22 and arsenic trioxide as above in consolidation therapy on approximately weeks 12-15 or weeks 17-20
NOTE For patients who receive a second course of induction therapy
Cohorts of 6 patients receive escalating doses of arsenic trioxide 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 toxicity
Phase II Patients receive arsenic trioxide at the MTD and imatinib mesylate as in phase I
Treatment in both phases continues in the absence of unacceptable toxicity or disease progression
After completion of consolidation therapy patients may continue imatinib mesylate off study at the discretion of the physician Patients who become candidates for stem cell transplantation at any time during the study are removed from study
PROJECTED ACCRUAL A total of 6-43 patients 6-12 for phase I and 37 including 6 patients from phase I for phase II will be accrued for this study within 2 years
Primary
Determine the maximum tolererated dose of arsenic trioxide when administered with imatinib mesylate in patients with accelerated or blastic phase chronic myelogenous leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia
Determine the rate of complete morphologic remission in the bone marrow of patients treated with this regimen
OUTLINE This is a phase I dose-escalation study of arsenic trioxide followed by a phase II study
Phase I
Induction therapy Patients receive oral imatinib mesylate once daily on days 1-35 weeks 1-5 and arsenic trioxide IV over 1-4 hours on days 1-5 8-12 15-19 and 22-26 weeks 1-4
Patients undergo bone marrow evaluation on week 5 Patients achieving a morphologic remission proceed to consolidation therapy Patients not achieving morphologic remission receive a second course of imatinib mesylate as above on weeks 6-10 and arsenic trioxide as above on weeks 6-9 Patients are re-evaluated on week 10 Patients achieving morphologic remission proceed to consolidation therapy Patients not achieving a morphologic remission are removed from study
Consolidation therapy Patients receive oral imatinib mesylate as in induction therapy on approximately weeks 6-11 or weeks 11-16 and arsenic trioxide IV over 1-4 hours on days 1 3 5 8 10 12 15 17 19 22 24 and 26 approximately weeks 6-9 OR weeks 11-14
Patients who remain in morphologic remission receive a second course of imatinib mesylate as in induction therapy on approximately weeks 12-17 or weeks 17-22 and arsenic trioxide as above in consolidation therapy on approximately weeks 12-15 or weeks 17-20
NOTE For patients who receive a second course of induction therapy
Cohorts of 6 patients receive escalating doses of arsenic trioxide 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 toxicity
Phase II Patients receive arsenic trioxide at the MTD and imatinib mesylate as in phase I
Treatment in both phases continues in the absence of unacceptable toxicity or disease progression
After completion of consolidation therapy patients may continue imatinib mesylate off study at the discretion of the physician Patients who become candidates for stem cell transplantation at any time during the study are removed from study
PROJECTED ACCRUAL A total of 6-43 patients 6-12 for phase I and 37 including 6 patients from phase I for phase II will be accrued for this study within 2 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000358923 | REGISTRY | PDQ Physician Data Query | None |