Trial Information

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

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.