This early phase I trial studies the side effects and feasibility of total body irradiation using intensity modulation radiation therapy (IMRT) when given in combination with cyclophosphamide prior to stem cell transplant to treat severe systemic sclerosis. IMRT delivers total body radiation therapy more precisely and may reduce radiation exposure to sensitive normal organs. Giving chemotherapy, such as cyclophosphamide, and total body irradiation before a donor stem cell transplant helps kill cancer cells in the body and helps make room in the bone marrow for new blood-forming cells (stem cells) to grow. Giving IMRT and cyclophosphamide prior to stem cell transplant may work better in treating severe systemic sclerosis and reduce radiation doses to lung and kidneys compared to cyclophosphamide alone.
Karnofsky performance status (KPS) >= 70
Systemic sclerosis patients evaluated within 30 days of start of conditioning regimen who would be candidates for TBI-cyclophosphamide (Cy) per City of Hope (COH) guidelines and standard operating procedures (SOP) for autologous hematopoietic cell transplant
Patients must be suitable for TBI conditioning regimens as part of transplant per radiation the referring hematologist
Patients must have adequate organ function for HCT as determined by the hematologist
Patients should not have any uncontrolled illness including ongoing or active infection
Prior history of radiation therapy must be presented to study principal investigator (PI) for eligibility determination
Pregnant women are excluded from this study because total body irradiation is an agent with the potential for teratogenic or abortifacient effects
Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
Single group
Allogeneic Hematopoietic Stem Cell Transplantation
Procedure/SurgeryUndergo HSCT
Cyclophosphamide
DrugUndergo HSCT
Intensity-Modulated Radiation Therapy
RadiationUndergo TBI using IMRT
Total-Body Irradiation
Procedure/SurgeryUndergo TBI using IMRT
Mean lung dose
The study will be deemed feasible if \>= 80% of patients complete the intensity modulation radiation therapy (IMRT) to the total dose of 800 cGy, mean lung and kidney doses are limited to 200 cGy or less.
Mean kidney dose
The study will be deemed feasible if \>= 80% of patients complete the IMRT to the total dose of 800 cGy, mean lung and kidney doses are limited to 200 cGy or less.
Dose homogeneity for lungs, kidneys, and total body
"Dose homogeneity for lung, kidney and total body will use the DVH (dose volume histograms) generated by the treatment plan for each of these regions. The goal is to keep the lung and kidney dose homogeneity to with +/- 15% of the mean dose to that organ. The goal is to keep total body dose homogeneity to within +/- 15% of the prescribed total body dose of 8 Gy."
Transplant-related mortality
Measured by comparing the transplant-related mortality rates on day 30 compared to day 100.
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City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
