NCT01795430

Whole-Body Radiation Therapy, Systemic Chemotherapy, and High-Dose Chemotherapy Followed By Stem Cell Rescue in Treating Patients With Poor-Risk Ewing Sarcoma

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 6 Months – 40 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Adult Supratentorial Primitive Neuroectodermal Tumor (PNET)
• Ewing Sarcoma of Bone
• Extraosseous Ewing Sarcoma
• Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
• Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor
• Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
• Untreated Childhood Supratentorial Primitive Neuroectodermal Tumor

Interventions

Type	Name	Description
DRUG	etoposide	Given IV
DRUG	ifosfamide	Given IV
RADIATION	intensity-modulated radiation therapy	Undergo WB-MRI-guided IMRT
DRUG	topotecan hydrochloride	Given IV
DRUG	busulfan	Given IV
DRUG	melphalan	Given IV
PROCEDURE	autologous hematopoietic stem cell transplantation	Undergo autologous peripheral blood stem cell or bone marrow transplant
PROCEDURE	peripheral blood stem cell transplantation	Undergo autologous peripheral blood stem cell transplant
PROCEDURE	autologous bone marrow transplantation	Undergo autologous bone marrow transplant

Timeline

• Start date: 2013-07-01
• Primary completion: 2018-03-01
• First posted: 2013-02-20
• Last updated: 2015-01-09

Locations

1 site across 1 country: United States