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

Withdrawn before enrolling · Not applicable

Conditions studied: 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

In brief

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

Key facts

Study ID: NCT01795430
Run by: City of Hope Medical Center
People needed: 0
Starts: 2013-07-01
Last updated by the study team: 2015-01-09

Who can join

Age: 1 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)
Bilirubin < 2 x upper limit of normal
Serum glutamic oxalo-acetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) < 5 x upper limit of normal
Platelet count > 50,000/ul
Absolute granulocyte count >= 750/ul
Forced expiratory volume in one second (FEV1) > 2 liters adults (older than 16 years)
Room air arterial oxygen pressure (PaO2) > 70 mm Hg adults (older than 16 years)
Room air partial pressure of carbon dioxide (PaCO2) < 42 mm Hg adults (older than 16 years)
Diffusion capacity of carbon monoxide (DLCO) > 50% predicted
If unable to cooperate with pulmonary function testing due to young age, then pulse oximetry >= 94% children (younger than 16 years)
Pretreatment tests must have been performed within 4 weeks prior to initiation of protocol treatment
No other medical and/or psychosocial problems which, in the opinion of the primary physician or principal investigator, would place the patient at unacceptable risk from this regimen
Greater than 2 week period of recovery from prior modality used to control primary or recurrent site
All subjects or their legal guardians must have the ability to understand and the willingness to sign a written informed consent

You may not qualify if…

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

Where it is running

City of Hope Medical Center — Duarte, California, United States

Full record on ClinicalTrials.gov

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