Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006021
Status:
COMPLETED
Last Update Posted:
2016-12-15
First Post:
2000-07-05
Brief Title:
Arsenic Trioxide Plus Vitamin C in Treating Patients With Recurrent or Refractory Multiple Myeloma
Sponsor:
University of Miami
Organization:
University of Miami
Study Overview
Official Title:
Phase III Trial of Arsenic Trioxide As2O3 With Ascorbic Acid in the Treatment of RelapsedRefractory Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 cancer cells from dividing so they stop growing or die Vitamin C may increase the effectiveness of arsenic trioxide by making cancer cells more sensitive to the drug
PURPOSE Phase III trial to determine the effectiveness of arsenic trioxide plus vitamin C in treating patients who have recurrent or refractory multiple myeloma
PURPOSE Phase III trial to determine the effectiveness of arsenic trioxide plus vitamin C in treating patients who have recurrent or refractory multiple myeloma
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of arsenic trioxide when administered with ascorbic acid in patients with recurrent or refractory multiple myeloma
Determine the therapeutic efficacy of this treatment combination in these patients
Determine the expression of MDR and Bcl-xL genes and the intracellular levels of GSH in these patients before and after this treatment regimen and assess whether these measures have prognostic value
OUTLINE This is a multicenter dose-escalation study of arsenic trioxide
Phase I Patients receive arsenic trioxide IV over 1-4 hours and ascorbic acid IV over 5-10 minutes on days 1-5 weekly for 5 weeks Treatment continues every 7 weeks for up to 6 courses 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 reached The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Patients receive the MTD of arsenic trioxide with ascorbic acid as outlined above
Patients are followed monthly for up to 5 years
PROJECTED ACCRUAL A total of 31-43 patients 6-18 for phase I and 16-25 for phase II will be accrued for this study within 25 years
Determine the maximum tolerated dose of arsenic trioxide when administered with ascorbic acid in patients with recurrent or refractory multiple myeloma
Determine the therapeutic efficacy of this treatment combination in these patients
Determine the expression of MDR and Bcl-xL genes and the intracellular levels of GSH in these patients before and after this treatment regimen and assess whether these measures have prognostic value
OUTLINE This is a multicenter dose-escalation study of arsenic trioxide
Phase I Patients receive arsenic trioxide IV over 1-4 hours and ascorbic acid IV over 5-10 minutes on days 1-5 weekly for 5 weeks Treatment continues every 7 weeks for up to 6 courses 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 reached The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Patients receive the MTD of arsenic trioxide with ascorbic acid as outlined above
Patients are followed monthly for up to 5 years
PROJECTED ACCRUAL A total of 31-43 patients 6-18 for phase I and 16-25 for phase II will be accrued for this study within 25 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 |
|---|---|---|---|
| CDR0000068033 | REGISTRY | None | None |
| SCCC-2000010 | OTHER | University of Miami Sylvester Comprehensive Cancer Center | None |