Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005786
Status:
TERMINATED
Last Update Posted:
2013-02-01
First Post:
2000-06-02
Brief Title:
Arsenic Trioxide in Treating Patients With Relapsed or Refractory Lymphoma or Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Pilot Study of Arsenic Trioxide in the Treatment of Relapsed and Refractory Indolent Lymphomas
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administratively complete
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have relapsed or refractory lymphoma or leukemia Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the safety and toxicity profile of arsenic trioxide in patients with relapsed or refractory low-grade lymphomas
II To determine the incidence of complete and partial responses to arsenic trioxide in patients with previously treated low-grade lymphomas
III To evaluate basic science correlates of arsenic trioxide activity in order to improve our understanding of the mechanism of action for arsenic trioxide in patients with low-grade lymphomas
OUTLINE This is a nonrandomized open-label study
Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 Treatment repeats every 21 days for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression Patients with responding or stable disease may receive 6 additional courses
Patients are followed every 3 months for up to 2 years
I To evaluate the safety and toxicity profile of arsenic trioxide in patients with relapsed or refractory low-grade lymphomas
II To determine the incidence of complete and partial responses to arsenic trioxide in patients with previously treated low-grade lymphomas
III To evaluate basic science correlates of arsenic trioxide activity in order to improve our understanding of the mechanism of action for arsenic trioxide in patients with low-grade lymphomas
OUTLINE This is a nonrandomized open-label study
Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 Treatment repeats every 21 days for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression Patients with responding or stable disease may receive 6 additional courses
Patients are followed every 3 months for up to 2 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 |
|---|---|---|---|
| CDR0000067719 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchR01CA085748 |
| GCO 99-884 ME | None | None | None |
| R01CA085748 | NIH | None | None |