Photodynamic Therapy in Treating Patients With Lymphoma or Chronic Lymphocytic Leukemia

NCT ID: NCT00054171

Last Updated: 2013-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-02-28

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.

Conditions

Leukemia; Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

aminolevulinic acid hydrochloride

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Principal Investigators

Allan R. Oseroff, MD, PhD

Role: STUDY_CHAIR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Countries

United States

Other Identifiers

RPCI-DS-9732

Identifier Type: -

Identifier Source: secondary_id

DS 97-32

Identifier Type: -

Identifier Source: org_study_id