Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030381
Status:
TERMINATED
Last Update Posted:
2013-01-16
First Post:
2002-02-14
Brief Title:
Iododoxorubicin in Treating Patients With Primary Systemic Amyloidosis
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Trial of 4-IODO-4-Deoxydoxorubicin in Primary Amyloidosis AL
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:
Iododoxorubicin may dissolve protein deposits and be an effective treatment for primary systemic amyloidosis Phase I trial to determine the effectiveness of iododoxorubicin in treating patients who have primary systemic amyloidosis
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose of iododoxorubicin in patients with primary systemic amyloidosis
SECONDARY OBJECTIVES
I Determine the safety especially cardiac safety of this drug in these patients
II Determine the survival rate of patients treated with this drug III Determine preliminarily the clinical efficacy of this drug in these patients
IV Determine the pharmacokinetics of this drug in these patients
OUTLINE This is a dose-escalation study
Patients receive iododoxorubicin IV over 15 minutes on days 1 8 15 and 22 Treatment repeats every 12 weeks for a total of 4 courses or a cumulative dose of 400 mgm2 in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of iododoxorubicin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed at 3 months
I Determine the maximum tolerated dose of iododoxorubicin in patients with primary systemic amyloidosis
SECONDARY OBJECTIVES
I Determine the safety especially cardiac safety of this drug in these patients
II Determine the survival rate of patients treated with this drug III Determine preliminarily the clinical efficacy of this drug in these patients
IV Determine the pharmacokinetics of this drug in these patients
OUTLINE This is a dose-escalation study
Patients receive iododoxorubicin IV over 15 minutes on days 1 8 15 and 22 Treatment repeats every 12 weeks for a total of 4 courses or a cumulative dose of 400 mgm2 in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of iododoxorubicin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed at 3 months
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 |
|---|---|---|---|
| CDR0000069160 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU01CA069912 |
| MC0113 | None | None | None |
| U01CA069912 | NIH | None | None |