Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006090
Status:
WITHDRAWN
Last Update Posted:
2012-10-10
First Post:
2000-08-03
Brief Title:
Arsenic Trioxide in Treating Patients With Refractory or Relapsed Chronic Lymphocytic Leukemia
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Study of Arsenic Trioxide NSC 706363 Therapy for Fludarabine Refractory or Relapsed Chronic Lymphocytic Leukemia
Status:
WITHDRAWN
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No enrollment
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
PURPOSE Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have chronic lymphocytic leukemia that has relapsed or has not responded to treatment with fludarabine
PURPOSE Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have chronic lymphocytic leukemia that has relapsed or has not responded to treatment with fludarabine
Detailed Description:
OBJECTIVES I Determine the clinical efficacy and safety of arsenic trioxide in patients with chronic lymphocytic leukemia CLL that is refractory to fludarabine or in relapse II Determine the pattern of clinical adverse experience in these patients when treated with this regimen III Evaluate the effects of this drug on cytokines apoptosis and angiogenesis in these patients
OUTLINE Patients receive arsenic trioxide IV over 2 hours on days 1-15 OR on days 1-5 8-12 and 15-19 Courses repeat with 2 to 5 week intervals between courses for 10-12 courses about 1 year in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months for 1 year every 6 months for the second year and then annually thereafter
PROJECTED ACCRUAL A total of 17-37 patients will be accrued for this study
OUTLINE Patients receive arsenic trioxide IV over 2 hours on days 1-15 OR on days 1-5 8-12 and 15-19 Courses repeat with 2 to 5 week intervals between courses for 10-12 courses about 1 year in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months for 1 year every 6 months for the second year and then annually thereafter
PROJECTED ACCRUAL A total of 17-37 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 |
|---|---|---|---|
| MDA-DM-00059 | None | None | None |
| NCI-310 | None | None | None |
| ID00-059 | OTHER | UT MD Anderson Cancer Center | None |