Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00061867
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
2003-06-05
Brief Title:
Liposomal Doxorubicin and Thermal Therapy in Treating Patients With Prostate Cancer
Sponsor:
Imunon
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Dose Escalation Pharmacokinetics and Safety Study of Doxorubicin Encapsulated in Temperature Sensitive Liposomes Released Through Microwave Therapy in the Treatment of Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2005-07
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 Drugs used in chemotherapy such as liposomal doxorubicin use different ways to stop tumor cells from dividing so they stop growing or die Microwave thermotherapy kills tumor cells by heating them to several degrees above body temperature Combining liposomal doxorubicin with microwave thermotherapy may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of liposomal doxorubicin when given together with microwave thermotherapy in treating patients with prostate cancer
PURPOSE This phase I trial is studying the side effects and best dose of liposomal doxorubicin when given together with microwave thermotherapy in treating patients with prostate cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of doxorubicin HCl liposome released through thermal microwave therapy in patients with adenocarcinoma of the prostate
Determine the pharmacokinetics and biodistribution profile of this drug in these patients
Determine the safety profile and dose-limiting toxicity of this drug in these patients
Determine the clinical response in patients treated with this regimen
OUTLINE This is an open-label dose-escalation multicenter study
Patients receive doxorubicin HCl liposome IV over 30 minutes Patients then undergo a 60-minute course of prostate thermotherapy Treatment may repeat every 28-42 days for up to 6 courses at the discretion of the physician
Cohorts of 3-6 patients receive escalating doses of doxorubicin HCl liposome until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed at 8 15 30 and 90 days
PROJECTED ACCRUAL Approximately 50 patients will be accrued for this study
Determine the maximum tolerated dose of doxorubicin HCl liposome released through thermal microwave therapy in patients with adenocarcinoma of the prostate
Determine the pharmacokinetics and biodistribution profile of this drug in these patients
Determine the safety profile and dose-limiting toxicity of this drug in these patients
Determine the clinical response in patients treated with this regimen
OUTLINE This is an open-label dose-escalation multicenter study
Patients receive doxorubicin HCl liposome IV over 30 minutes Patients then undergo a 60-minute course of prostate thermotherapy Treatment may repeat every 28-42 days for up to 6 courses at the discretion of the physician
Cohorts of 3-6 patients receive escalating doses of doxorubicin HCl liposome until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed at 8 15 30 and 90 days
PROJECTED ACCRUAL Approximately 50 patients will be accrued for this study
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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RPCI-DS-0228 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000301761 | REGISTRY | None | None |