Photodynamic Therapy in Treating Patients With Lymphoma or Chronic Lymphocytic Leukemia

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Leukemia, Lymphoma

Intervention / Treatment
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* Drug: aminolevulinic acid hydrochloride


Participation Criteria
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Eligibility Criteria
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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: Age Not specified Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Other 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 Surgery Not specified Other More than 1 month since prior topical therapy to study lesions Concurrent topical therapy to non-study lesions allowed
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: aminolevulinic acid hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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B-cell chronic lymphocytic leukemia, stage I cutaneous T-cell non-Hodgkin lymphoma, stage I mycosis fungoides/Sezary syndrome, stage 0 chronic lymphocytic leukemia, stage I chronic lymphocytic leukemia