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| Name | Class |
|---|---|
| Actelion | INDUSTRY |
The clinical efficacy of mechlorethamine gel (Valchlor) as a maintenance therapy after low dose total skin electron beam therapy (TSEBT) for the treatment mycosis fungoides cutaneous T-cell lymphoma will be evaluated in this study. Subjects will be treated with low dose TSEBT (12 Gy total) over a period of two weeks. After a 30 day observation period and confirmation that their disease stage has been downgraded to IA or IB, subjects will use Valchlor as a maintenance therapy over the course of one year. The efficacy of Valchlor as a maintenance drug will be followed clinically through Modified Severity Weight Assessment Tool (mSWAT) and percent body surface area measurements (%BSA). Furthermore, subjects will be followed histopathologically through skin biopsies performed at the screening visit, immediately after observation period, one month after the start of the maintenance period, and twelve months after the start of the maintenance period (4 biopsies total).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TSEBT & mechlorethamine gel 0.016% | Experimental | All subjects enrolled in the study will receive two weeks of low dose total skin electron beam therapy (TSEBT) (12 Gy total divided into 6 fractions delivered over two weeks) followed by a weekly maintenance mechlorethamine gel 0.016% regimen for one year. The initiation of the mechlorethamine gel regimen is dependent on their disease stage downgrading to IA and IB following low dose TSEBT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total skin electron beam therapy (TSEBT) | Radiation | TSEBT will be given in 6 fractions at 2 Gy per fraction every Monday, Wednesday, and Friday over the course of 2 weeks (total TSEBT dosage is 12 Gy). Supplements up to 8 Gy will routinely be applied to the perineum and soles as well as any other "shadowed" sites involved by disease, such as the inframammary regions, scalp, etc. Discrete tumors may receive additional "boost" up to 8 Gy. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to progression | To assess the time to progression of patients treated with total skin electron beam therapy (TSEBT) followed by the year-long maintenance Valchlor regimen. | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate (CR and PR) | To assess the response rate (CR and PR) of patients treated with total skin electron beam therapy (TSEBT) followed by the year-long maintenance Valchlor regimen. . CR and PR are defined as the standard oncology criteria for complete response (100% reduction from the baseline score) and partial response (50% to <100% reduction from the baseline score). | One year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kelly Knoblauch | Contact | (215) 955-9295 | kelly.knoblauch@jefferson.edu |
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| mechlorethamine gel 0.016% | Drug | The maintenance period for this study includes one year of weekly mechlorethamine gel 0.016%. This period will not begin until the observation period (30 days) has been completed. During the first week of the maintenance period, patients will apply mechlorethamine gel to the entire body surface daily. After the first week, patients will apply mechlorethamine gel to entire body surface one time per week for the rest of the maintenance period. |
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|
| ID | Term |
|---|---|
| D009182 | Mycosis Fungoides |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000588 | Amines |
| ID | Term |
|---|---|
| D009930 | Organic Chemicals |
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