Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005080
Status:
COMPLETED
Last Update Posted:
2013-01-16
First Post:
2000-04-06
Brief Title:
506U78 in Treating Patients With Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of 506U78 in Patients With Previously Systemically Untreated Cutaneous T-cell Lymphoma CTCL or With Refractory or Relapsed Non-cutaneous Peripheral T-cell Lymphoma PTCL
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Phase II trial to study the effectiveness of 506U78 in treating patients who have lymphoma that has not been treated previously or that has not responded to previous treatment Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die
Detailed Description:
PRIMARY OBJECTIVES
I Determine the complete and partial remission rates and remission duration in patients with cutaneous T-cell lymphoma or refractory or relapsed noncutaneous peripheral T-cell lymphoma treated with 506U78
II Determine the safety and toxicity of this treatment regimen in this patient population
OUTLINE
Patients receive 506U78 IV over 2 hours on days 1 3 and 5 Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity Patients achieving complete response receive up to 8 courses of therapy
Patients are followed every 3 months for 1 year and then every 6 months for 1 year or until relapse
PROJECTED ACCRUAL A total of 34-74 patients will be accrued for this study within 3 years
I Determine the complete and partial remission rates and remission duration in patients with cutaneous T-cell lymphoma or refractory or relapsed noncutaneous peripheral T-cell lymphoma treated with 506U78
II Determine the safety and toxicity of this treatment regimen in this patient population
OUTLINE
Patients receive 506U78 IV over 2 hours on days 1 3 and 5 Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity Patients achieving complete response receive up to 8 courses of therapy
Patients are followed every 3 months for 1 year and then every 6 months for 1 year or until relapse
PROJECTED ACCRUAL A total of 34-74 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 |
|---|---|---|---|
| CDR0000067687 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| CALGB-59901 | None | None | None |
| U10CA031946 | NIH | None | None |