Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00258245
Status:
COMPLETED
Last Update Posted:
2013-04-29
First Post:
2005-11-22
Brief Title:
Arsenic Trioxide and Ascorbic Acid Combined With Bortezomib Thalidomide and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma or Plasma Cell Leukemia
Sponsor:
Barbara Ann Karmanos Cancer Institute
Organization:
Barbara Ann Karmanos Cancer Institute
Study Overview
Official Title:
A Phase I Study of Arsenic Trioxide and Ascorbic Acid ATOAA in Combination With Low Dose Velcade-Thalidomide-Dexamethasone VTD in RelapsedRefractory Multiple Myeloma MM
Status:
COMPLETED
Status Verified Date:
2013-04
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 and dexamethasone work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Ascorbic acid may help arsenic trioxide work better by making cancer cells more sensitive to the drug Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth Thalidomide may stop the growth of cancer cells by stopping blood flow to the cancer Giving arsenic trioxide and ascorbic acid together with bortezomib thalidomide and dexamethasone may stop the growth of and kill more cancer cells
PURPOSE This phase I trial is studying the side effects and best dose of arsenic trioxide when given together with ascorbic acid bortezomib thalidomide and dexamethasone in treating patients with relapsed or refractory multiple myeloma or plasma cell leukemia
PURPOSE This phase I trial is studying the side effects and best dose of arsenic trioxide when given together with ascorbic acid bortezomib thalidomide and dexamethasone in treating patients with relapsed or refractory multiple myeloma or plasma cell leukemia
Detailed Description:
OBJECTIVES
Primary
Determine the dose-limiting toxicity of arsenic trioxide when given in combination with ascorbic acid bortezomib thalidomide and dexamethasone particularly in terms of sensory neuropathy in patients with relapsed or refractory multiple myeloma or plasma cell leukemia
Secondary
Determine the overall response rate complete response rate and response duration in patients treated with the maximum tolerated dose of this regimen
Determine whether the addition of arsenic trioxide and ascorbic acid to the treatment regimen beginning in course 2 increases NFKB inhibition in these patients during courses 2 and 3 compared to course 1
OUTLINE This is a multicenter dose-escalation study of arsenic trioxide
Induction therapy Patients receive bortezomib IV over 3-5 seconds and dexamethasone IV or orally on days 1 4 8 and 11 and oral thalidomide once daily on days 1-21 course 1 For course 2 and all subsequent courses patients receive arsenic trioxide IV over 1-2 hours ascorbic acid IV over 15 minutes bortezomib IV over 3-5 seconds and dexamethasone IV or orally on days 1 4 8 and 11 and thalidomide once daily on days 1-21 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients who achieve a plateau in response proceed to maintenance therapy
Maintenance therapy Patients receive oral dexamethasone every other day and oral thalidomide once daily in the absence of disease progression or unacceptable toxicity
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 3 or 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A total of 24 patients will be accrued for this study
Primary
Determine the dose-limiting toxicity of arsenic trioxide when given in combination with ascorbic acid bortezomib thalidomide and dexamethasone particularly in terms of sensory neuropathy in patients with relapsed or refractory multiple myeloma or plasma cell leukemia
Secondary
Determine the overall response rate complete response rate and response duration in patients treated with the maximum tolerated dose of this regimen
Determine whether the addition of arsenic trioxide and ascorbic acid to the treatment regimen beginning in course 2 increases NFKB inhibition in these patients during courses 2 and 3 compared to course 1
OUTLINE This is a multicenter dose-escalation study of arsenic trioxide
Induction therapy Patients receive bortezomib IV over 3-5 seconds and dexamethasone IV or orally on days 1 4 8 and 11 and oral thalidomide once daily on days 1-21 course 1 For course 2 and all subsequent courses patients receive arsenic trioxide IV over 1-2 hours ascorbic acid IV over 15 minutes bortezomib IV over 3-5 seconds and dexamethasone IV or orally on days 1 4 8 and 11 and thalidomide once daily on days 1-21 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients who achieve a plateau in response proceed to maintenance therapy
Maintenance therapy Patients receive oral dexamethasone every other day and oral thalidomide once daily in the absence of disease progression or unacceptable toxicity
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 3 or 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A total of 24 patients will be accrued for this study
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 |
|---|---|---|---|
| WSU-HIC-01705M1F | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA022453 |
| P30CA022453 | NIH | None | None |
| WSU-D-2869 | None | None | None |