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

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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

NCT01795430•City of Hope Medical Center

View on ClinicalTrials.gov

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.

Eligibility

Age

0 - 40 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients with relapsed Ewing's sarcoma or primitive neuroectodermal tumor (PNET) with bony/soft tissue metastasis who achieved at least partial response (PR) to chemotherapy, surgery or radiotherapy
•Newly diagnosed patients with metastatic disease to the bones: patients with metastatic Ewing's or metastatic PNET who achieved at least partial response (PR) to chemotherapy, surgery or radiotherapy are eligible
•Ewing's sarcoma/PNET histology confirmed by Anatomic Pathology Department; histological confirmation of relapse is highly recommended but not mandatory
•Patients must have documented at least partial response (PR) to previous therapy regimens; previous modalities may include surgery, chemotherapy, or radiation therapy; radiation must not include lung fields; only patients in CR or PR at the primary site will be eligible
•Patients must have metastatic/recurrent disease identified by WB-MRI at the time of study entry; intensity-modulated radiation therapy (IMRT) can be delivered per protocol guidelines to at least one but not more than five primary/metastatic sites
•Patients must have Karnofsky performance status \> 60% OR Lansky performance status \> 50% for patients younger than 16 years old
•Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
•Adequate number of autologous stem cells collected and cryopreserved prior to starting the study treatment
•Creatinine clearance (12 or 24 hour urine collection) or glomerular filtration rate (GFR) \> 60 ml/min/1.73 m\^2
•Ejection fraction \> 50% by echocardiogram or multiple gated acquisition (MUGA)
+13 more criteria

Exclusion Criteria

•Patients should not have any uncontrolled illness including ongoing or active infection
•Patients may not be receiving any other investigational agents, concurrent biological agents, or chemotherapy
•Patients must not have received prior chemotherapy or radiation within 2 weeks before study enrollment, and those who have not recovered from the adverse events due to agents administered more than 2 weeks earlier are excluded
•Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated on this study
•Patients with other active malignancies are ineligible for this study
•Patients with prior treatment with myeloablative therapy are excluded
•Karnofsky performance status \< 60% or Lansky performance status \< 50% for patients younger than 16 years old
•Patients who require irradiation to more than 5 disease sites are excluded
•Subjects who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

Locations (1)

City of Hope Medical Center

Duarte, California, United States

Key Dates

Start Date

July 1, 2013

Primary Completion Date

March 1, 2018

Last Updated

January 9, 2015

Conditions

Adult Supratentorial Primitive Neuroectodermal Tumor (PNET)Ewing Sarcoma of BoneExtraosseous Ewing SarcomaMetastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal TumorRecurrent Childhood Supratentorial Primitive Neuroectodermal TumorRecurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal TumorUntreated Childhood Supratentorial Primitive Neuroectodermal Tumor

Interventions

etoposide

DRUG

ifosfamide

DRUG

intensity-modulated radiation therapy

RADIATION

topotecan hydrochloride

DRUG

busulfan

DRUG

melphalan

DRUG

autologous hematopoietic stem cell transplantation

PROCEDURE

peripheral blood stem cell transplantation

PROCEDURE

autologous bone marrow transplantation

PROCEDURE

Observational Study on Skeletal Ewing's Sarcoma

NCT04845893

Ewing Sarcoma of Bone

View study

WITHDRAWNPHASE2

Phase 2 Study of 9-ING-41 With Chemotherapy in Sarcoma

NCT05116800

Soft Tissue SarcomaUndifferentiated Pleomorphic Sarcoma+11 more

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COMPLETEDEARLY_PHASE1

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 9, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Observational Study on Skeletal Ewing's Sarcoma

Phase 2 Study of 9-ING-41 With Chemotherapy in Sarcoma

18F-FLT Positron Emission Tomography and Diffusion-Weighted Magnetic Resonance Imaging in Planning Surgery and Radiation Therapy and Measuring Response in Patients With Newly Diagnosed Ewing Sarcoma

Efficacy of 68Ga-DOTATOC Positron Emission Tomography (PET) CT in Children and Young Adults With Brain Tumors

Vincristine Sulfate, Topotecan Hydrochloride, and Cyclophosphamide With or Without Bevacizumab in Treating Young Patients With Refractory or First Recurrent Extracranial Ewing Sarcoma