Refractory Mycosis Fungoides Clinical Trial
Official title:
Prospective Observational Trial of Low-Dose Total Skin Electron Therapy in Mycosis Fungoides Using Rotisserie Technique
This clinical trial studies low- dose total skin electron therapy in treating patients with stage IB-IIIA mycosis fungoides that has not responded to previous treatment (refractory) or has returned after a period of improvement (relapsed). Radiation therapy uses high energy electrons to kill tumor cells and shrink tumors. Rotisserie technique is a method in which the patient receives total skin electron therapy while standing on a rotating platform. Giving low dose total skin electron therapy using rotisserie technique may kill tumor cells, while having fewer side effects, and may allow therapy to be repeated in future if clinically indicated.
PRIMARY OBJECTIVES: I. To assess the skin-related quality of life using an established method (Skindex-29), with comparisons made between pre-treatment and each of follow-up post-treatment skin assessments. II. To assess the durability of response using an established method (modified Severity-Weight Assessment [mSWAT] tool), with comparisons made between pre-treatment and each of follow-up post-treatment skin assessments. III. To determine side effect profile for low dose total skin electron therapy (TSE) for mycosis fungoides administered via rotisserie technique. OUTLINE: The investigational portion of this research study involves collecting quality of life (QOL) questionnaire data and objective measurements of patients' skin responses, which are obtained by the radiation oncologist during the patient's standard of care radiation treatment planning. Patients will also undergo standard of care low-dose total skin electron therapy for under 1 hour daily on days 10-21. After completion of study treatment, patients are followed up at 6 and 12 weeks, and then every 3 months thereafter. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT02978625 -
Talimogene Laherparepvec and Nivolumab in Treating Patients With Refractory Lymphomas or Advanced or Refractory Non-melanoma Skin Cancers
|
Phase 2 | |
| Active, not recruiting |
NCT03278782 -
Study of Pembrolizumab (MK-3475) in Combination With Romidepsin
|
Phase 1/Phase 2 | |
| Completed |
NCT03281811 -
Photodynamic Therapy in Treating Patients With Refractory Mycosis Fungoides
|
Early Phase 1 | |
| Terminated |
NCT03075553 -
Nivolumab in Treating Patients With Relapsed or Refractory Peripheral T-cell Lymphoma
|
Phase 2 | |
| Recruiting |
NCT03011814 -
Durvalumab With or Without Lenalidomide in Treating Patients With Relapsed or Refractory Cutaneous or Peripheral T Cell Lymphoma
|
Phase 1/Phase 2 | |
| Suspended |
NCT03432741 -
Direct Tumor Microinjection and FDG-PET in Testing Drug Sensitivity in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Stage IV Breast Cancer
|
Phase 1 | |
| Withdrawn |
NCT03373305 -
Brentuximab Vedotin and Lenalidomide in Treating Patients With Relapsed or Refractory T-Cell Lymphomas
|
Phase 1 | |
| Active, not recruiting |
NCT04074746 -
Modified Immune Cells (AFM13-NK) and A Monoclonal Antibody (AFM13) in Treating Patients With Recurrent or Refractory CD30 Positive Hodgkin or Non-Hodgkin Lymphomas
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03598998 -
Pembrolizumab and Pralatrexate in Treating Patients With Relapsed or Refractory Peripheral T-Cell Lymphomas
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT04541017 -
Testing the Addition of an Anti-cancer Drug, Hu5F9-G4 (Magrolimab), to the Usual Chemotherapy Treatment (Mogamulizumab) in T-Cell (a Type of Immune Cell) Lymphoma That Has Returned After Treatment or Does Not Respond to Treatment
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03017820 -
VSV-hIFNbeta-NIS in Treating Patients With Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia or Lymphoma
|
Phase 1 |