Two Regimens of Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed Localized Ewing Sarcoma Family of Tumors

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This clinical trial is studying the side effects of combination chemotherapy and to see how well they work in treating patients with newly diagnosed localized Ewing sarcoma family of tumors. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving the drugs in different ways may kill more tumor cells.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cyclophosphamide; Doxorubicin; Etoposide; Etoposide phosphate; Ifosfamide; Liposomal doxorubicin; Topotecan; Vincristine

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