Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025571
Status:
COMPLETED
Last Update Posted:
2011-03-07
First Post:
2001-10-11
Brief Title:
Photodynamic Therapy With HPPH in Treating Patients With Non-Small Cell Lung Cancer
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
A Phase I Study of Photodynamic Therapy PDT Using 2-1-hexyloxyethyl-2 Devinyl Pyropheophorbide-a HPPH for Treatment of Early Stage Lung Cancer - A Dose Ranging Study
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 trial to study the effectiveness of photodynamic therapy with HPPH in treating patients who have non-small cell lung cancer
PURPOSE Phase I trial to study the effectiveness of photodynamic therapy with HPPH in treating patients who have non-small cell lung cancer
Detailed Description:
OBJECTIVES
Determine the systemic and normal tissue toxicity of photodynamic therapy with HPPH in patients with early stage or centrally obstructing non-small cell lung cancer
Determine preliminarily the efficacy of this regimen in these patients
OUTLINE This is a dose-escalation study of HPPH
Patients receive HPPH IV over 1 hour on day 1 Patients undergo laser light therapy via bronchoscopy on day 3
Cohorts of 3-6 patients receive escalating doses of HPPH 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 for at least 6 months
PROJECTED ACCRUAL Approximately 15-17 patients will be accrued for this study within 2 years
Determine the systemic and normal tissue toxicity of photodynamic therapy with HPPH in patients with early stage or centrally obstructing non-small cell lung cancer
Determine preliminarily the efficacy of this regimen in these patients
OUTLINE This is a dose-escalation study of HPPH
Patients receive HPPH IV over 1 hour on day 1 Patients undergo laser light therapy via bronchoscopy on day 3
Cohorts of 3-6 patients receive escalating doses of HPPH 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 for at least 6 months
PROJECTED ACCRUAL Approximately 15-17 patients will be accrued for this study within 2 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 |
|---|---|---|---|
| RPCI-RP-0005 | None | None | None |