Photodynamic Therapy in Treating Patients With Lymphoma or Chronic Lymphocytic Leukemia

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00054171
First received: February 5, 2003
Last updated: January 30, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Leukemia
Lymphoma
Drug: aminolevulinic acid hydrochloride
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Pain grade and epidermal toxic response (ETR) [ Designated as safety issue: Yes ]
  • Feasibility of maintaining a pain grade of 1 or less and an approximate ETR of 2 [ Designated as safety issue: No ]
  • Maximal irradiance and corresponding exposure [ Designated as safety issue: No ]
  • Cumulative response achieved at the completion of treatment [ Designated as safety issue: No ]
  • Number of sessions required to complete treatment [ Designated as safety issue: No ]
  • Correlation of ETR with incremental treatment response [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: February 1999
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00054171

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Study Chair: Allan R. Oseroff, MD, PhD Roswell Park Cancer Institute
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00054171     History of Changes
Other Study ID Numbers: DS 97-32, RPCI-DS-9732
Study First Received: February 5, 2003
Last Updated: January 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Roswell Park Cancer Institute:
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

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 18, 2014