Clinical trial NCT00054171: Photodynamic Therapy in Treating Patients With Lymphoma or Chronic Lymphocytic Leukemia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Leukemia
Lymphoma
Keywords: 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
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-02-06
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

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.

Eligibility 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:

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

Primary outcomes:
measure: Pain grade and epidermal toxic response (ETR)
measure: Feasibility of maintaining a pain grade of 1 or less and an approximate ETR of 2
measure: Maximal irradiance and corresponding exposure
measure: Cumulative response achieved at the completion of treatment
measure: Number of sessions required to complete treatment
measure: Correlation of ETR with incremental treatment response
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Allan R. Oseroff, MD, PhD
role: STUDY_CHAIR
References: