Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005040
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2000-04-06
Brief Title:
Arsenic Trioxide in Treating Patients With Relapsed or Refractory Non- Hodgkins Lymphoma
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase II Study of Arsenic Trioxide NSC 706363 in Relapsed and Refractory Intermediate and High-Grade Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2013-06
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 use different ways to stop cancer 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 relapsed or refractory non-Hodgkins lymphoma
PURPOSE Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have relapsed or refractory non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES I Determine the complete and partial response rates duration of complete response freedom from progression event free survival and overall survival in patients with relapsed or refractory intermediate or high grade lymphoma treated with arsenic trioxide II Determine the toxicity of this regimen in these patients
OUTLINE Patients receive arsenic trioxide IV over 2-4 hours for a maximum of 25 cumulative days followed by a rest period of 3-4 weeks Patients with complete or partial response may receive 6 additional courses in the absence of disease progression or unacceptable toxicity Patients with minor response 25-50 tumor regression may also receive further courses of treatment Patients are followed at 4 weeks
PROJECTED ACCRUAL A total of 22-41 patients will be accrued for this study
OUTLINE Patients receive arsenic trioxide IV over 2-4 hours for a maximum of 25 cumulative days followed by a rest period of 3-4 weeks Patients with complete or partial response may receive 6 additional courses in the absence of disease progression or unacceptable toxicity Patients with minor response 25-50 tumor regression may also receive further courses of treatment Patients are followed at 4 weeks
PROJECTED ACCRUAL A total of 22-41 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 |
|---|---|---|---|
| NCI-T99-0062 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067631 | REGISTRY | None | None |