Photodynamic Therapy in Treating Patients With Lymphoma or Chronic Lymphocytic Leukemia
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.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Short (1-2.5 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|
- Pain grade and epidermal toxic response (ETR) [ Designated as safety issue: Yes ]
- Feasibility of maintaining a pain grade of 1 or less and an approximate ETR of 2 [ Designated as safety issue: No ]
- Maximal irradiance and corresponding exposure [ Designated as safety issue: No ]
- Cumulative response achieved at the completion of treatment [ Designated as safety issue: No ]
- Number of sessions required to complete treatment [ Designated as safety issue: No ]
- Correlation of ETR with incremental treatment response [ Designated as safety issue: No ]
|Study Start Date:||February 1999|
|Primary Completion Date:||July 2005 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00054171
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Study Chair:||Allan R. Oseroff, MD, PhD||Roswell Park Cancer Institute|