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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Pain grade and epidermal toxic response (ETR)
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Primary Purpose
- Treatment
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •DISEASE CHARACTERISTICS:
- •One of the following histologically confirmed diagnoses:
- •Cutaneous B-cell or T-cell lymphoma confined to the skin
- •No evidence of internal disease other than peripheral adenopathy
- •Early chronic lymphocytic leukemia with cutaneous B-cell infiltrates not requiring systemic therapy
- •Stable or slowly progressive disease that is not expected to substantially change during treatment
- •PATIENT CHARACTERISTICS:
- •Not specified
- •Performance status
- •Not specified
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •Not pregnant or nursing
- •No porphyria or known hypersensitivity to porphyrins
- •No known photosensitivity diseases
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Concurrent clinically necessary interferon alfa allowed
- •Chemotherapy
- •No concurrent systemic multiagent chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •No concurrent local radiotherapy to study lesions
- •No concurrent whole body radiotherapy
- •Not specified
- •More than 1 month since prior topical therapy to study lesions
- •Concurrent topical therapy to non-study lesions allowed
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Pain grade and epidermal toxic response (ETR)
Feasibility of maintaining a pain grade of 1 or less and an approximate ETR of 2
Maximal irradiance and corresponding exposure
Cumulative response achieved at the completion of treatment
Number of sessions required to complete treatment
Correlation of ETR with incremental treatment response
Secondary Outcomes
No secondary outcomes reported