Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054171
Status:
COMPLETED
Last Update Posted:
2013-01-31
First Post:
2003-02-05
Brief Title:
Photodynamic Therapy in Treating Patients With Lymphoma or Chronic Lymphocytic Leukemia
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
A Pilot Study of Short 1-25 h Medium 4-6 h and Long 18-24 h Applications of 20 Topical ALA-PDT for Photodynamic Therapy of Cutaneous T and B Cell Lymphomas and Cutaneous Infiltrates of Early CLL
Status:
COMPLETED
Status Verified Date:
2013-01
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 cancer cells more sensitive to light to kill cancer cells Photosensitizing drugs such as aminolevulinic acid are absorbed by cancer cells and when exposed to light become active and kill the cancer cells
PURPOSE Randomized phase II trial to study the effectiveness of photodynamic therapy using aminolevulinic acid in treating patients who have cutaneous T-cell lymphoma B-cell lymphoma or early chronic lymphocytic leukemia involving the skin
PURPOSE Randomized phase II trial to study the effectiveness of photodynamic therapy using aminolevulinic acid in treating patients who have cutaneous T-cell lymphoma B-cell lymphoma or early chronic lymphocytic leukemia involving the skin
Detailed Description:
OBJECTIVES
Determine the pain grade and epidermal toxic response ETR of patients with T-cell or B-cell lymphoma or early chronic lymphocytic leukemia with cutaneous infiltrates treated with photodynamic therapy using aminolevulinic acid
Determine the feasibility of maintaining a pain grade of 1 or less and an approximate ETR of 2 in patients receiving up to 12 sessions of this regimen
Determine the maximal irradiance and corresponding exposure among multiple treatments at the same site and among different sites in the same and in different patients
Determine the cumulative response achieved at the completion of treatment in these patients
Determine the number of sessions required to complete treatment in these patients
Correlate ETR with incremental treatment response in patients treated with this regimen
OUTLINE This is a randomized study Patients individual lesions are randomized to 1 of 3 treatment arms
Arm I Patients receive a short duration of topical aminolevulinic acid ALA on the lesion and surrounding normal skin The lesion is then illuminated with red light for up to 30 minutes
Arm II Patients receive a medium duration of ALA followed by light illumination as in arm I
Arm III Patients receive a long duration of ALA followed by light illumination as in arm I
In all arms treatment repeats every 2 weeks for up to 12 courses in the absence of unacceptable toxicity or progressive systemic disease
Additional patients are accrued to a treatment arm if at least 2 of 3 patients on that arm experience 25 cumulative clinical response
Patients are followed at 1 3 and 6 months and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 4-10 patients will be accrued for this study within 5-7 years
Determine the pain grade and epidermal toxic response ETR of patients with T-cell or B-cell lymphoma or early chronic lymphocytic leukemia with cutaneous infiltrates treated with photodynamic therapy using aminolevulinic acid
Determine the feasibility of maintaining a pain grade of 1 or less and an approximate ETR of 2 in patients receiving up to 12 sessions of this regimen
Determine the maximal irradiance and corresponding exposure among multiple treatments at the same site and among different sites in the same and in different patients
Determine the cumulative response achieved at the completion of treatment in these patients
Determine the number of sessions required to complete treatment in these patients
Correlate ETR with incremental treatment response in patients treated with this regimen
OUTLINE This is a randomized study Patients individual lesions are randomized to 1 of 3 treatment arms
Arm I Patients receive a short duration of topical aminolevulinic acid ALA on the lesion and surrounding normal skin The lesion is then illuminated with red light for up to 30 minutes
Arm II Patients receive a medium duration of ALA followed by light illumination as in arm I
Arm III Patients receive a long duration of ALA followed by light illumination as in arm I
In all arms treatment repeats every 2 weeks for up to 12 courses in the absence of unacceptable toxicity or progressive systemic disease
Additional patients are accrued to a treatment arm if at least 2 of 3 patients on that arm experience 25 cumulative clinical response
Patients are followed at 1 3 and 6 months and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 4-10 patients will be accrued for this study within 5-7 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-DS-9732 | None | None | None |