Ignite Creation Date:
2025-12-18 @ 8:11 AM
Ignite Modification Date:
2025-12-23 @ 9:03 PM
Study NCT ID:
NCT00020124
Status:
None
Last Update Posted:
2012-03-15 00:00:00
First Post:
2001-07-11 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Inhaled Doxorubicin in Treating Patients With Advanced Solid Tumors Affecting the Lungs
Sponsor:
None
Organization:
Study Overview
Official Title:
Phase I and Clinical Pharmacologic Study of Inhaled Doxorubicin in Adults With Advanced Solid Tumors Affecting the Lungs
Status:
None
Status Verified Date:
2012-03
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:
OBJECTIVES:
* Determine the maximum tolerated dose and phase II dose of inhaled doxorubicin in patients with advanced solid tumors affecting the lungs.
* Determine the toxicity of this regimen in these patients.
* Determine the pharmacokinetic profile of inhaled doxorubicin in blood in these patients.
* Determine the relationship between pharmacodynamic parameters and toxic effects of this regimen in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive inhaled doxorubicin every 3 weeks for up to 3 doses. Patients with stable or responding disease may receive additional doses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of doxorubicin 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 weeks and 3 months.
PROJECTED ACCRUAL: Approximately 33 patients will be accrued for this study within 18-24 months.
* Determine the maximum tolerated dose and phase II dose of inhaled doxorubicin in patients with advanced solid tumors affecting the lungs.
* Determine the toxicity of this regimen in these patients.
* Determine the pharmacokinetic profile of inhaled doxorubicin in blood in these patients.
* Determine the relationship between pharmacodynamic parameters and toxic effects of this regimen in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive inhaled doxorubicin every 3 weeks for up to 3 doses. Patients with stable or responding disease may receive additional doses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of doxorubicin 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 weeks and 3 months.
PROJECTED ACCRUAL: Approximately 33 patients will be accrued for this study within 18-24 months.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: