Two Regimens of Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed Localized Ewing Sarcoma Family of Tumors
Ewing Sarcoma of Bone, Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
About this trial
This is an interventional treatment trial for Ewing Sarcoma of Bone
Eligibility Criteria
Inclusion Criteria:
Diagnosis of extracranial Ewing sarcoma or peripheral primitive neuroectodermal tumor of bone or soft tissue:
- Newly diagnosed disease
Disease confirmed by biopsy only with no attempt at complete or partial resection
- Unplanned excision allowed provided adequate imaging was obtained prior to surgery and incompletely resected disease is controlled by local therapy
- No esthesioneuroblastoma
Localized disease, including any of the following sites:
Chest wall tumors with ipsilateral pleural effusions, ipsilateral positive pleural fluid cytology, or ipsilateral pleural based secondary tumor nodules;
- No contralateral pleural effusions or pleural nodules
Regional lymph nodes that are clinically suspicious or confirmed by biopsy
- No distant lymph node metastases
Extra-dural tumors arising in the bony skull
- No tumors arising in the intra-dural soft tissue or the intra-dural region of the spine
No evidence of metastatic disease, defined as any of the following:
- Lesions that are discontinuous from the primary tumor
- Lesions that are not regional lymph nodes
- Lesions that do not share a body cavity with the primary tumor
No evidence by CT scan of metastatic lung disease, defined as any of the following:
One pulmonary nodule > 1 cm in diameter or more than one nodule > 0.5 cm diameter
- Pulmonary nodules that are resected and are not found to be metastatic Ewing sarcoma are allowed
Biopsy proven solitary nodules measuring 0.5 to 1.0 cm or multiple nodules measuring 0.3 to 0.5 cm
- Solitary nodules measuring < 0.5 cm or multiple nodules measuring < 0.3 cm are allowed unless biopsy proven to be metastatic (biopsy is not required)
- Karnofsky performance status (PS) 0-2 (>= 16 years old) OR Lansky PS 0-2 (< 16 years old)
Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR serum creatinine based on age/gender as follows:
- 1 month to < 6 months old (males and females 0.4 mg/dL)
- 6 months to < 1 year old (males and females 0.5 mg/dL)
- 1 to < 2 years old (males and females 0.6 mg/dL)
- 2 to < 6 years old (males and females 0.8 mg/dL)
- 6 to < 10 years old (males and females 1.0 mg/dL)
- 10 to < 13 years old (males and females 1.2 mg/dL)
- 13 to < 16 years old (males 1.5 mg/dL and females 1.4 mg/dL)
- >= 16 years old (males 1.7 mg/dL and females 1.4 mg/dL)
- AST or ALT < 2.5 times ULN for age
- Total bilirubin =< 1.5 times upper limit of normal (ULN) for age
- Shortening fraction of >= 27% by ECHO or ejection fraction of >= 50% by radionuclide angiogram (MUGA)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior chemotherapy or radiotherapy
- No concurrent pegfilgrastim (Neulasta) or sargramostim (GM-CSF)
- No other concurrent cancer chemotherapy or immunomodulating agents, including steroids, unless used as an antiemetic
Sites / Locations
- Children's Oncology Group
Arms of the Study
Arm 1
Experimental
Treatment (combination chemotherapy)
See Detailed Description