Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003853
Status:
COMPLETED
Last Update Posted:
2012-11-12
First Post:
1999-11-01
Brief Title:
4-Iodo-4-Deoxydoxorubicin in Treating Patients With Primary Systemic Amyloidosis
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial of 4-IODO-4-Deoxydoxorubicin in Primary Amyloidosis AL
Status:
COMPLETED
Status Verified Date:
2011-05
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 4-Iodo-4-deoxydoxorubicin may improve organ dysfunction and ease symptoms caused by primary systemic amyloidosis
PURPOSE Phase II trial to study the effectiveness of 4-iodo-4-deoxydoxorubicin in treating patients who have primary systemic amyloidosis
PURPOSE Phase II trial to study the effectiveness of 4-iodo-4-deoxydoxorubicin in treating patients who have primary systemic amyloidosis
Detailed Description:
OBJECTIVES I Evaluate the clinical efficacy of 4-iodo-4-deoxydoxorubicin in producing palliation of symptoms andor improvement of organ dysfunction caused by organ infiltration by amyloid in patients with primary systemic amyloidosis II Assess the safety profile with emphasis on cardiac safety of this drug in these patients III Evaluate the time to progression of amyloidosis-associated clinical symptoms andor organ dysfunction duration of response and survival of these patients on this regimen
OUTLINE Patients receive 4-iodo-4-deoxydoxorubicin IV over 1 hour once a week for 4 weeks Courses are repeated every 12 weeks Treatment continues for up to 4 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 6 months
PROJECTED ACCRUAL A total of 45 patients will be accrued for this study within 1 year
OUTLINE Patients receive 4-iodo-4-deoxydoxorubicin IV over 1 hour once a week for 4 weeks Courses are repeated every 12 weeks Treatment continues for up to 4 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 6 months
PROJECTED ACCRUAL A total of 45 patients will be accrued for this study within 1 year
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 |
|---|---|---|---|
| 302-99 | OTHER | Mayo Clinic IRB | httpsreporternihgovquickSearchP30CA015083 |
| P30CA015083 | NIH | None | None |
| 988003 | OTHER | None | None |
| T98-0003 | OTHER | None | None |