Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor Clinical Trial
Official title:
A Pilot Study of Whole-body MRI-guided Intensity Modulated Radiation Therapy Combined With Systemic Chemotherapy Followed by High-Dose Chemotherapy With Busulfan, Melphalan and Topotecan and Stem Cell Rescue in Patients With Poor Risk Ewing's Sarcoma
This pilot clinical trial studies whole-body radiation therapy, systemic chemotherapy, and high-dose chemotherapy followed by stem cell rescue in treating patients with poor-risk Ewing sarcoma. Giving chemotherapy and radiation therapy before a peripheral blood stem cell or bone marrow transplant stops the growth of tumor cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is given to prepare the bone marrow for stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy
PRIMARY OBJECTIVES:
I. To assess the safety and feasibility of whole-body magnetic resonance imaging
(WB-MRI)-guided intensity modulated radiation therapy delivered concurrently with systemic
chemotherapy to sites of metastatic disease in patients with relapsed, refractory and/or
poor risk Ewing sarcoma.
II. To assess the safety and feasibility of a novel consolidation regimen consisting of
busulfan, melphalan and topotecan (topotecan hydrochloride) followed by autologous stem cell
rescue, to be administered immediately after completion of radiation therapy in patients
with relapsed, refractory and/or poor risk Ewing sarcoma.
SECONDARY OBJECTIVES:
I. To characterize the timing of myeloid and platelet engraftment.
II. To estimate the overall and progression free survival probabilities.
III. To estimate the cumulative incidence of relapse/progression and non-relapse related
mortality.
IV. To report the overall response rate (overall response rate [ORR]: complete response
[CR]+partial response [PR]) and response duration.
V. To descriptively compare the diagnostic imaging results (number and site of bone
metastases) of whole-body MR imaging to those obtained by skeletal scintigraphy.
OUTLINE:
BLOCK I: Patients receive etoposide intravenously (IV) over 1-2 hours and ifosfamide IV over
1 hour on days 1-5. Patients also undergo WB-MRI-guided intensity-modulated radiation
therapy twice daily (BID), 5 days a week, for approximately 4 weeks. Patients may also
undergo 4 fractions of stereotactic radiation therapy (SRT) every other day (QOD), 3-8
fractions of stereotactic body radiation therapy (SBRT) QOD, or 10 fractions of
3-dimensional radiation therapy (3D RT) daily to sites of metastatic disease.
BLOCK II: Patients receive high-dose chemotherapy comprising topotecan hydrochloride IV
continuously over 24 hours on days -8 to -4, busulfan IV over 2 hours every 6 hours on days
-8 to -4, and melphalan IV over 30 minutes on days -3 and -2. Patients undergo autologous
peripheral blood or bone marrow stem cell infusion on day 0.
After the stem cell infusion, patients are followed up for up to 5 years.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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