LeukemiaPhase 2NCT00054171
Photodynamic Therapy in Treating Patients With Lymphoma or Chronic Lymphocytic Leukemia
A Phase 2 study testing aminolevulinic acid hydrochloride in people with Leukemia and Lymphoma, run by Roswell Park Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- aminolevulinic acid hydrochloride
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 1999to Jul 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
About this study
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
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.
Read the 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.
- Being tested
- aminolevulinic acid hydrochloride
- Keywords
- 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
- Medical subject headings
- Leukemia, Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides, Sezary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aminolevulinic acid hydrochlorideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2003 (estimated)
- Study startFeb 1999
- Primary completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Allan R. Oseroff, MD, PhD, Study chair, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00054171
- Sponsor's protocol ID
- DS 97-32
- Other IDs
- RPCI-DS-9732
- Status last verified
- Jan 2013
- First submitted
- 5 Feb 2003
- Last updated
- 31 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00054171
- Acronym / sponsor ID
- DS 97-32
- Keywords
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 1999
- Primary completion
- Jul 2005 (actual)
- First posted
- 6 Feb 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aminolevulinic acid hydrochloride | Drug | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allan R. Oseroff, MD, PhD study chair
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing aminolevulinic acid hydrochloride in people with Leukemia and Lymphoma, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain grade and epidermal toxic response (ETR). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2013; AzTrials last refreshed its copy on 8 Nov 2026.