Photodynamic Therapy in Treating Patients With Lymphoma or Chronic Lymphocytic Leukemia

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00054171
• Other study ID #: DS 97-32
• Secondary ID: RPCI-DS-9732
• Status: Completed
• Phase: Phase 2
• First received: February 5, 2003
• Last updated: January 30, 2013
• Start date: February 1999

Study information

• Verified date: January 2013
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma

Intervention

Drug:
• aminolevulinic acid hydrochloride

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain grade and epidermal toxic response (ETR)			Yes
Primary	Feasibility of maintaining a pain grade of 1 or less and an approximate ETR of 2			No
Primary	Maximal irradiance and corresponding exposure			No
Primary	Cumulative response achieved at the completion of treatment			No
Primary	Number of sessions required to complete treatment			No
Primary	Correlation of ETR with incremental treatment response			No