Ignite Creation Date:
2024-05-05 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005982
Status:
TERMINATED
Last Update Posted:
2013-01-23
First Post:
2000-07-05
Brief Title:
506U78 in Treating Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of 506U78 NSC 686673 in Patients With Previously Treated Cutaneous T-Cell Lymphoma
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:
Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Phase II trial to study the effectiveness of 506U78 in treating patients who have recurrent or refractory cutaneous T-cell lymphoma
Detailed Description:
PRIMARY OBJECTIVES
I Determine the response rate failure-free survival and progression-free survival of patients with recurrent or refractory cutaneous T-cell lymphoma treated with 506U78
II Determine the toxicity of this drug in these patients III Study the pharmacokinetics of this drug in these patients
OUTLINE This is a multicenter study
Patients receive 506U78 IV over 2 hours on days 1 3 and 5 Treatment continues every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 months
PROJECTED ACCRUAL A total of 12-35 patients will be accrued for this study within 3 years
I Determine the response rate failure-free survival and progression-free survival of patients with recurrent or refractory cutaneous T-cell lymphoma treated with 506U78
II Determine the toxicity of this drug in these patients III Study the pharmacokinetics of this drug in these patients
OUTLINE This is a multicenter study
Patients receive 506U78 IV over 2 hours on days 1 3 and 5 Treatment continues every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 6 months
PROJECTED ACCRUAL A total of 12-35 patients will be accrued for this study within 3 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 |
|---|---|---|---|
| CDR0000067970 | REGISTRY | PDQ Physician Data Query | None |
| ID99-213 | None | None | None |