| Phase II Randomized Pilot Study of Photodynamic Therapy Using Aminolevulinic Acid in Patients With Cutaneous T-Cell or B-Cell Lymphoma or Early Chronic Lymphocytic Leukemia With Cutaneous Infiltrates
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Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Alternate Title
Photodynamic Therapy in Treating Patients With Lymphoma or Chronic Lymphocytic Leukemia
Basic Trial Information
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Phase II
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RPCI-DS-9732
NCT00054171
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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.
Entry 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
Prior/Concurrent Therapy:
Biologic therapy - Concurrent clinically necessary interferon alfa allowed
Chemotherapy - No concurrent systemic multiagent chemotherapy
Endocrine therapy Radiotherapy - No concurrent local radiotherapy to study lesions
- No concurrent whole body radiotherapy
Surgery Other - More than 1 month since prior topical therapy to study lesions
- Concurrent topical therapy to non-study lesions allowed
Patient Characteristics:
Age Performance status Life expectancy Hematopoietic Hepatic Renal Other - Not pregnant or nursing
- No porphyria or known hypersensitivity to porphyrins
- No known photosensitivity diseases
Expected Enrollment A total of 4-10 patients will be accrued for this study within 5-7 years. Outcomes Primary Outcome(s)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
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.
Trial Contact Information
Trial Lead Organizations Roswell Park Cancer Institute | | | | Allan Oseroff, MD, PhD, Protocol chair | | | |
| Registry Information | | | 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 | | | Trial Start Date | | 1999-02-17 | | | Registered in ClinicalTrials.gov | | NCT00054171 | | | Date Submitted to PDQ | | 2002-12-17 | | | Information Last Verified | | 2005-11-01 | | | NCI Grant/Contract Number | | P30-CA16056 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.  Back to Top |
