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| ID | Type | Description | Link |
|---|---|---|---|
| RPCI-DS-9732 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aminolevulinic acid hydrochloride | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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DISEASE CHARACTERISTICS:
One of the following histologically confirmed diagnoses:
Cutaneous B-cell or T-cell lymphoma confined to the skin
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
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Allan R. Oseroff, MD, PhD | Roswell Park Cancer Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D009182 | Mycosis Fungoides |
| D012751 | Sezary Syndrome |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000622 | Aminolevulinic Acid |
| ID | Term |
|---|---|
| D007982 | Levulinic Acids |
| D007651 | Keto Acids |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |