NCT00054171

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_2 leukemia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1999

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 6, 2003

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
Last Updated

January 31, 2013

Status Verified

January 1, 2013

Enrollment Period

6.4 years

First QC Date

February 5, 2003

Last Update Submit

January 30, 2013

Conditions

LeukemiaLymphoma

Keywords

B-cell chronic lymphocytic leukemiastage I cutaneous T-cell non-Hodgkin lymphomastage I mycosis fungoides/Sezary syndromestage 0 chronic lymphocytic leukemiastage I chronic lymphocytic leukemia

Outcome Measures

Primary Outcomes (6)

  • 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

Interventions

aminolevulinic acid hydrochlorideDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

LeukemiaLymphomaLeukemia, Lymphocytic, Chronic, B-CellLymphoma, T-Cell, CutaneousMycosis FungoidesSezary Syndrome

Interventions

Aminolevulinic Acid

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, B-CellLeukemia, LymphoidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, T-CellLymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Levulinic AcidsKeto AcidsCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Allan R. Oseroff, MD, PhD

    Roswell Park Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 5, 2003

First Posted

February 6, 2003

Study Start

February 1, 1999

Primary Completion

July 1, 2005

Last Updated

January 31, 2013

Record last verified: 2013-01

Locations

US(1)