Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2025-12-28 @ 1:59 AM
Study NCT ID:
NCT00060268
Status:
COMPLETED
Last Update Posted:
2011-03-09
First Post:
2003-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Photodynamic Therapy Using HPPH in Treating Patients With Obstructive Esophageal Tumors
Sponsor:
Roswell Park Cancer Institute
Organization:
Study Overview
Official Title:
A Phase I/II Trial for Treatment of Obstructive Esophageal Tumors by Photodynamic Therapy (PDT) Using 2-(1-Hydroxyethyl)-2-Devinylpyropheophorbide-a (HPPH)
Status:
COMPLETED
Status Verified Date:
2011-03
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:
RATIONALE: Photodynamic therapy uses light and drugs that make tumor cells more sensitive to light to kill tumor cells. Photosensitizing drugs such as HPPH are absorbed by tumor cells and, when exposed to light, become active and kill the tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of photodynamic therapy with HPPH in treating patients who have obstructive esophageal tumors.
PURPOSE: Phase I/II trial to study the effectiveness of photodynamic therapy with HPPH in treating patients who have obstructive esophageal tumors.
Detailed Description:
OBJECTIVES:
* Determine, preliminarily, the safety of HPPH in patients with obstructive esophageal tumors undergoing photodynamic therapy.
* Determine, preliminarily, tumor response in patients treated with this drug.
* Determine the length of time for cutaneous photosensitivity at the various drug doses in these patients.
* Determine plasma clearance rates for this drug in these patients.
OUTLINE: This is a dose-escalation study.
* Phase I: Patients receive HPPH IV over 1 hour on day 1. Patients then undergo laser light therapy on day 2.
Cohorts of 3 patients receive escalating doses of HPPH and a single light dose until the optimal dose is determined. The optimal dose is defined as the minimum dose producing efficacy without unacceptable toxicity.
* Phase II: Patients receive treatment as in phase I at the optimal dose. Patients are followed monthly for 6-24 months.
PROJECTED ACCRUAL: A total of 9-14 patients will be accrued for this study.
* Determine, preliminarily, the safety of HPPH in patients with obstructive esophageal tumors undergoing photodynamic therapy.
* Determine, preliminarily, tumor response in patients treated with this drug.
* Determine the length of time for cutaneous photosensitivity at the various drug doses in these patients.
* Determine plasma clearance rates for this drug in these patients.
OUTLINE: This is a dose-escalation study.
* Phase I: Patients receive HPPH IV over 1 hour on day 1. Patients then undergo laser light therapy on day 2.
Cohorts of 3 patients receive escalating doses of HPPH and a single light dose until the optimal dose is determined. The optimal dose is defined as the minimum dose producing efficacy without unacceptable toxicity.
* Phase II: Patients receive treatment as in phase I at the optimal dose. Patients are followed monthly for 6-24 months.
PROJECTED ACCRUAL: A total of 9-14 patients will be accrued for this study.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| RPCI-DS-9701 | None | None | View |