Pilot Study of Total Body Irradiation Using Intensity Modulated Radiation Therapy (IMRT) and Cyclophosphamide Conditioning Regimen Prior to Autologous Hematopoietic Cell Transplantation in Patients With Severe Systemic Sclerosis
City of Hope Medical Center
Summary
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.
Description
PRIMARY OBJECTIVES: I. To assess the feasibility of using IMRT to deliver total body irradiation (TBI) to 800 cGy while keeping mean lung and kidney doses to 200 cGy. II. To assess the safety/feasibility of total body irradiation using IMRT (IMRT TBI) in systemic sclerosis patients undergoing autologous hematopoietic stem cell transplantation. SECONDARY OBJECTIVES: I. To evaluate dose homogeneity and dose sparing to lung and kidneys. II. To evaluate transplant-related mortality at 30 days and 100 days post IMRT TBI. OUTLINE: Patients undergo TBI using IMRT twice daily (BID) on days -5 an…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 * Women of child-bearing potential and men must agree to use adequ…
Interventions
- ProcedureAllogeneic Hematopoietic Stem Cell Transplantation
Undergo HSCT
- DrugCyclophosphamide
Undergo HSCT
- RadiationIntensity-Modulated Radiation Therapy
Undergo TBI using IMRT
- ProcedureTotal-Body Irradiation
Undergo TBI using IMRT
Location
- City of Hope Medical CenterDuarte, California