Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006220
Status:
TERMINATED
Last Update Posted:
2013-02-06
First Post:
2000-09-11
Brief Title:
Arsenic Trioxide With or Without Tretinoin in Treating Patients With Hematologic Cancer That Has Not Responded to Previous Therapy
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Arsenic Trioxide Alone or With ATRA Vesanoid for Resistant Hematologic Malignancy
Status:
TERMINATED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study drug became commercially available
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 use different ways to stop tumor cells from dividing so they stop growing or die Tretinoin may help hematologic cancer cells develop into normal white blood cells
PURPOSE Phase III trial to study the effectiveness of arsenic trioxide with or without tretinoin in treating patients who have hematologic cancer that has not responded to previous therapy
PURPOSE Phase III trial to study the effectiveness of arsenic trioxide with or without tretinoin in treating patients who have hematologic cancer that has not responded to previous therapy
Detailed Description:
This is a dose escalation and efficacy study of arsenic trioxide In the efficacy study patients are stratified according to diagnosis acute myelogenous leukemia vs acute lymphocytic leukemia vs myelodysplastic syndrome vs multiple myeloma vs non-Hodgkins lymphoma and Hodgkins disease Phase I Patients receive arsenic trioxide IV over 2 hours daily for 28 days Treatment repeats every 42-59 days in the absence of disease progression or unacceptable toxicity Patients who achieve complete remission CR or partial remission PR receive up to 4 courses Patients who fail to achieve CR or PR or who experience disease progression may receive arsenic trioxide and tretinoin daily for 28 days every 42-59 days for up to 7 courses Patients who fail to achieve CR or PR or experience disease progression with arsenic trioxide and tretinoin are removed from study Cohorts of 3-6 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 toxicities Phase II Patients receive the MTD of arsenic trioxide as in phase I for up to 7 courses Patients who fail to achieve CR or PR after 3 courses or experience disease progression are either taken off study or treated with arsenic trioxide and tretinoin as in phase I Patients are followed monthly for 6 months and then every 3 months for 18 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 |
|---|---|---|---|
| NCI-V00-1608 | None | None | None |
| WU-99-0236 | None | None | None |