Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005595
Status:
TERMINATED
Last Update Posted:
2012-06-11
First Post:
2000-05-02
Brief Title:
Arsenic Trioxide in Treating Patients With Relapsed or Refractory Hodgkins Disease
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Multicenter Phase II Trial of Arsenic Trioxide in Relapsed and Refractory Hodgkins Disease
Status:
TERMINATED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to accrue subjects in a timely fashion
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 relapsed or refractory Hodgkins disease
PURPOSE Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have relapsed or refractory Hodgkins disease
Detailed Description:
OBJECTIVES I Determine the efficacy of arsenic trioxide in terms of rate of response complete or partial remission duration of response relapse free survival and overall survival in patients with relapsed or refractory Hodgkins disease II Evaluate the toxicities of this agent in this patient population III Elucidate the mechanism of action of this treatment by measuring induction of apoptosis and caspace activation when given to these patients
OUTLINE This is a multicenter study Patients receive arsenic trioxide IV over 1-2 hours daily for up to 60 days After 4-6 weeks of rest patients receive up to 5 additional courses of therapy of 25 days each followed by 4-6 weeks of rest Patients with a complete response CR receive 1 additional course of 25 days after achieving CR Treatment continues in the absence of unacceptable toxicity or disease progression Patients are followed monthly for 6 months every 2 months for 6 months every 3 months for 12 months and then every 6 months thereafter
PROJECTED ACCRUAL A total of 12-35 patients will be accrued for this study within 2 years
OUTLINE This is a multicenter study Patients receive arsenic trioxide IV over 1-2 hours daily for up to 60 days After 4-6 weeks of rest patients receive up to 5 additional courses of therapy of 25 days each followed by 4-6 weeks of rest Patients with a complete response CR receive 1 additional course of 25 days after achieving CR Treatment continues in the absence of unacceptable toxicity or disease progression Patients are followed monthly for 6 months every 2 months for 6 months every 3 months for 12 months and then every 6 months thereafter
PROJECTED ACCRUAL A total of 12-35 patients will be accrued for this study within 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 |
|---|---|---|---|
| NCI-T99-0093 | None | None | None |
| NU-99H5 | None | None | None |