|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
Roswell Park Cancer Institute National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00054171 |
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 |
Phase II |
| MedlinePlus related topics: | Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma |
| Drug Information available for: | Aminolevulinic acid Aminolevulinic acid hydrochloride |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| 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 Start Date: | February 1999 |
OBJECTIVES:
OUTLINE: This is a randomized study. Patients' individual lesions are randomized to 1 of 3 treatment arms.
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 |
DISEASE CHARACTERISTICS:
One of the following histologically confirmed diagnoses:
Cutaneous B-cell or T-cell lymphoma confined to the skin
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, New York | |||||
| Roswell Park Cancer Institute | |||||
| Buffalo, New York, United States, 14263-0001 | |||||
| Roswell Park Cancer Institute |
| National Cancer Institute (NCI) |
| Study Chair: | Allan R. Oseroff, MD, PhD | Roswell Park Cancer Institute |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000269906, RPCI-DS-9732 |
| First Received: | February 5, 2003 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00054171 |
| Health Authority: | United States: Federal Government |
|
|
|
|
|