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| Tracking Information | |||||
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| First Received Date ICMJE | February 5, 2003 | ||||
| Last Updated Date | July 23, 2008 | ||||
| Start Date ICMJE | February 1999 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00054171 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Active Control | ||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: aminolevulinic acid | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00054171 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000269906, RPCI-DS-9732 | ||||
| Study Sponsor ICMJE | Roswell Park Cancer Institute | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | November 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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