Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005939
Status:
UNKNOWN
Last Update Posted:
2013-11-06
First Post:
2000-07-05
Brief Title:
Brachytherapy in Treating Patients With Recurrent Prostate Cancer
Sponsor:
Center for Molecular Medicine
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Study of Interstitial Colloidal 32P for Locally Recurrent Prostate Cancer Failing Radiation
Status:
UNKNOWN
Status Verified Date:
2001-02
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Radiation therapy uses high-energy radiation to damage tumor cells Brachytherapy uses radioactive material that is placed directly into or near the tumor Brachytherapy may kill more tumor cells
PURPOSE Phase III trial to study the effectiveness of brachytherapy in treating patients who have recurrent prostate cancer that has not responded to standard therapy
PURPOSE Phase III trial to study the effectiveness of brachytherapy in treating patients who have recurrent prostate cancer that has not responded to standard therapy
Detailed Description:
OBJECTIVES I Determine the dosimetry and toxicity of interstitial colloidal phosphorus P32 cP32 in patients with locally recurrent prostate cancer that has failed conventional therapy II Determine the maximum tolerated dose of interstitial cP32 when combined with interstitial macroaggregated albumin infusional brachytherapy in these patients III Determine the therapeutic response rate to acceptable single doses of cP32 in these patients
OUTLINE This is a dose escalation study of colloidal phosphorus P32 cP32 Patients receive cP32 and macroaggregated albumin via interstitial infusion using ultrasound localization Cohorts of 3 patients receive escalating doses of cP32 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 4 patients experience dose limiting toxicities Additional patients are treated at the MTD Patients are followed at 1 2 4 and 6 weeks then at 2 4 8 12 16 20 and 24 months and then every 6 months thereafter until death
PROJECTED ACCRUAL A total of 20-25 patients will be accrued for phase I of the study and a total of 40 patients will be accrued for phase II of the study
OUTLINE This is a dose escalation study of colloidal phosphorus P32 cP32 Patients receive cP32 and macroaggregated albumin via interstitial infusion using ultrasound localization Cohorts of 3 patients receive escalating doses of cP32 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 4 patients experience dose limiting toxicities Additional patients are treated at the MTD Patients are followed at 1 2 4 and 6 weeks then at 2 4 8 12 16 20 and 24 months and then every 6 months thereafter until death
PROJECTED ACCRUAL A total of 20-25 patients will be accrued for phase I of the study and a total of 40 patients will be accrued for phase II of the study
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 |
|---|---|---|---|
| NCI-V00-1585 | None | None | None |
| CMM-99025 | None | None | None |