Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00227682
Status:
TERMINATED
Last Update Posted:
2012-05-28
First Post:
2005-09-26
Brief Title:
Arsenic Trioxide Thalidomide Dexamethasone and Ascorbic Acid in Treating Patients With Relapsed or Refractory Multiple Myeloma
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official Title:
A Phase II Study of Arsenic Trioxide in Combination With Thalidomide Dexamethasone and Ascorbic Acid
Status:
TERMINATED
Status Verified Date:
2010-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Terminated early due to funding suspension by grant sponsor
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 dexamethasone and ascorbic acid work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more cancer cells Sometimes when chemotherapy is given it does not stop the growth of cancer cells The cancer is said to be resistant to chemotherapy Giving arsenic trioxide together with chemotherapy may reduce drug resistance and allow the cancer cells to be killed Thalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer Giving arsenic trioxide together with thalidomide dexamethasone and ascorbic acid may kill more cancer cells
PURPOSE This phase II trial is studying how well giving arsenic trioxide together with thalidomide dexamethasone and ascorbic acid works in treating patients with relapsed or refractory multiple myeloma
PURPOSE This phase II trial is studying how well giving arsenic trioxide together with thalidomide dexamethasone and ascorbic acid works in treating patients with relapsed or refractory multiple myeloma
Detailed Description:
OBJECTIVES
Determine the safety and side effects of arsenic trioxide administered in combination with thalidomide dexamethasone and ascorbic acid in patients with relapsed or refractory multiple myeloma
Determine preliminarily the anticancer effects of this regimen in these patients
Determine the duration of anticancer effects in patients treated with this regimen
Determine the effect of this regimen on bone and immune function in these patients
OUTLINE Patients receive arsenic trioxide IV continuously and oral ascorbic acid once daily on days 1-5 in week 1 and twice weekly in weeks 2-12 and oral thalidomide once daily in weeks 1-14 Treatment with arsenic trioxide ascorbic acid and thalidomide repeats every 14 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity Patients also receive oral dexamethasone once daily on days 1-4 Treatment with dexamethasone repeats every 28 days
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
Determine the safety and side effects of arsenic trioxide administered in combination with thalidomide dexamethasone and ascorbic acid in patients with relapsed or refractory multiple myeloma
Determine preliminarily the anticancer effects of this regimen in these patients
Determine the duration of anticancer effects in patients treated with this regimen
Determine the effect of this regimen on bone and immune function in these patients
OUTLINE Patients receive arsenic trioxide IV continuously and oral ascorbic acid once daily on days 1-5 in week 1 and twice weekly in weeks 2-12 and oral thalidomide once daily in weeks 1-14 Treatment with arsenic trioxide ascorbic acid and thalidomide repeats every 14 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity Patients also receive oral dexamethasone once daily on days 1-4 Treatment with dexamethasone repeats every 28 days
PROJECTED ACCRUAL A total of 30 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 |
|---|---|---|---|
| OHSU-1277 | OTHER | None | None |
| OHSU-HEM-03100-L | OTHER | None | None |
| P30CA069533 | NIH | OHSU Knight Cancer Institute | httpsreporternihgovquickSearchP30CA069533 |