Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Photodynamic Therapy in Treating Patients With Lymphoma or Chronic Lymphocytic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00054171
Recruitment Status : Completed
First Posted : February 6, 2003
Last Update Posted : January 31, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Roswell Park Cancer Institute

Tracking Information
First Submitted Date  ICMJE February 5, 2003
First Posted Date  ICMJE February 6, 2003
Last Update Posted Date January 31, 2013
Study Start Date  ICMJE February 1999
Actual Primary Completion Date July 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2007)
  • Pain grade and epidermal toxic response (ETR)
  • Feasibility of maintaining a pain grade of 1 or less and an approximate ETR of 2
  • Maximal irradiance and corresponding exposure
  • Cumulative response achieved at the completion of treatment
  • Number of sessions required to complete treatment
  • Correlation of ETR with incremental treatment response
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00054171 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Photodynamic Therapy in Treating Patients With Lymphoma or Chronic Lymphocytic Leukemia
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Primary Purpose: Treatment
Condition  ICMJE
  • Leukemia
  • Lymphoma
Intervention  ICMJE Drug: aminolevulinic acid hydrochloride
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 30, 2013)
1
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date July 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00054171
Other Study ID Numbers  ICMJE DS 97-32
RPCI-DS-9732
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Roswell Park Cancer Institute
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Allan R. Oseroff, MD, PhD Roswell Park Cancer Institute
PRS Account Roswell Park Cancer Institute
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP