Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005067
Status:
TERMINATED
Last Update Posted:
2013-01-16
First Post:
2000-04-06
Brief Title:
Photodynamic Therapy With Lutetium Texaphyrin in Treating Patients With Locally Recurrent Prostate Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Trial of Photodynamic Therapy With Lutetium Texaphyrin in Patients With Locally Recurrent Prostate Carcinoma
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:
This phase I trial is studying the side effects and best dose of photodynamic therapy with lutetium texaphyrin in treating patients with locally recurrent prostate cancer Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells This may be effective treatment for locally recurrent prostate cancer Photosensitizing drugs such as lutetium texaphyrin are absorbed by cancer cells and when exposed to light become active and kill the cancer cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the dose limiting toxicities and maximum tolerated dose of photodynamic therapy PDT using 730 nm light and lutetium texaphyrin in patients with locally recurrent prostate adenocarcinoma who have failed previous definitive radiotherapy
SECONDARY OBJECTIVES
I Measure lutetium texaphyrin levels in needle biopsies of the prostate before and after PDT using an HPLC and tissue fluorescence assay and calculate the percent change in lutetium texaphyrin after treatment
II Measure lutetium texaphyrin fluorescence in situ in the prostate before and after PDT using optical methods and correlate these results with the direct tissue measurements made in the biopsies of these patients
III Determine clinical outcome including clinical response progression free survival time to complete response time to biochemical relapse time to local progression time to distant failure overall survival and disease specific survival in these patients treated with this regimen
OUTLINE This is a dose-escalation study of lutetium texaphyrin and light fluence
Patients receive lutetium texaphyrin IV over 10-15 minutes 3-24 hours before photodynamic therapy PDT Optical fibers attached to a laser are inserted through a catheter into the prostate The laser delivers 730 nm light to the prostate until the specified fluence is delivered Patients undergo biopsy of the prostate and bladder before and after PDT Cohorts of 3-6 patients receive escalating doses of lutetium texaphyrin and light fluence until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity
Patients are followed at 2 weeks 1 month 2 months 3 months then every 3 months until 2 years then every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A minimum of 24 patients will be accrued for this study within 3 years
I Determine the dose limiting toxicities and maximum tolerated dose of photodynamic therapy PDT using 730 nm light and lutetium texaphyrin in patients with locally recurrent prostate adenocarcinoma who have failed previous definitive radiotherapy
SECONDARY OBJECTIVES
I Measure lutetium texaphyrin levels in needle biopsies of the prostate before and after PDT using an HPLC and tissue fluorescence assay and calculate the percent change in lutetium texaphyrin after treatment
II Measure lutetium texaphyrin fluorescence in situ in the prostate before and after PDT using optical methods and correlate these results with the direct tissue measurements made in the biopsies of these patients
III Determine clinical outcome including clinical response progression free survival time to complete response time to biochemical relapse time to local progression time to distant failure overall survival and disease specific survival in these patients treated with this regimen
OUTLINE This is a dose-escalation study of lutetium texaphyrin and light fluence
Patients receive lutetium texaphyrin IV over 10-15 minutes 3-24 hours before photodynamic therapy PDT Optical fibers attached to a laser are inserted through a catheter into the prostate The laser delivers 730 nm light to the prostate until the specified fluence is delivered Patients undergo biopsy of the prostate and bladder before and after PDT Cohorts of 3-6 patients receive escalating doses of lutetium texaphyrin and light fluence until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity
Patients are followed at 2 weeks 1 month 2 months 3 months then every 3 months until 2 years then every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A minimum of 24 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 |
|---|---|---|---|
| UPCC 6899 | None | None | None |
| CDR0000067672 | REGISTRY | PDQ Physician Data Query | None |