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Photodynamic Therapy in Treating Patients With Lymphoma or Chronic Lymphocytic Leukemia Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Photodynamic Therapy in Treating Patients With Lymphoma or Chronic Lymphocytic Leukemia conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Photodynamic Therapy in Treating Patients With Lymphoma or Chronic Lymphocytic Leukemia Clinical research trials and Photodynamic Therapy in Treating Patients With Lymphoma or Chronic Lymphocytic Leukemia health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Photodynamic Therapy in Treating Patients With Lymphoma or Chronic Lymphocytic Leukemia. Photodynamic Therapy in Treating Patients With Lymphoma or Chronic Lymphocytic Leukemia Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Photodynamic Therapy in Treating Patients With Lymphoma or Chronic Lymphocytic Leukemia clinical trial. Subjects frequently get the best healthcare possible for their Photodynamic Therapy in Treating Patients With Lymphoma or Chronic Lymphocytic Leukemia condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Photodynamic Therapy in Treating Patients With Lymphoma or Chronic Lymphocytic Leukemia  Photodynamic Therapy in Treating Patients With Lymphoma or Chronic Lymphocytic Leukemia
Photodynamic Therapy in Treating Patients With Lymphoma or Chronic Lymphocytic Leukemia
For Condition: stage 1 chronic lymphocytic leukemia,stage 1 cutaneous T-cell lymphoma,B-cell Chronic Lymphocytic Leukemia,stage 0 chronic lymphocytic leukemia,stage 1 mycosis fungoides/Sezary syndrome
Status: Recruiting
Sponsor(s): Roswell Park Cancer Institute , National Cancer Institute (NCI)
Synopsis: 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: Randomizedphase I trial to study the effectiveness of photodynamic therapy using aminolevulinic acid in treating patients who have cutaneous T-cell lymphoma, B-celllymphoma, or early chronic lymphocytic leukemia involving the skin.
Details: 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 1-2.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AllanOseroff, Study Chair, Roswell Park Cancer Institute
Roswell Park Cancer Institute *Recruiting*
Buffalo, New York, 14263-0001
United States
Recruiting Allan Oseroff 716-845-8816
Additional Information:
Study ID Numbers: CDR0000269906; RPCI-DS-9732
Study Start Date:
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00054171
Other Stage 0 Chronic Lymphocytic Leukemia Studies:
1. Bexarotene and Interferon alfa in Treating Patients With Cutaneous T-Cell Lymphoma
2. O(6)-benzylguanine and Carmustine in Treating Patients With Stage I or Stage II Cutaneous T-cell Lymphoma
3. Chemotherapy and Photodynamic Therapy in Treating Patients With Cutaneous T-Cell Lymphoma
4. Photodynamic Therapy in Treating Patients With Lymphoma or Chronic Lymphocytic Leukemia
Related Studies:
Other stage 0 chronic lymphocytic leukemia Clinical Trials
Other New York Clinical Trials
Other Buffalo Clinical Trials
Photodynamic Therapy in Treating Patients With Lymphoma or Chronic Lymphocytic Leukemia
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