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

Not Recruiting

Trial ID: NCT00618813


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.

Official Title

A Pilot Study of Chemotherapy Intensification by Adding Vincristine, Topotecan and Cyclophosphamide to Standard Chemotherapy Agents With an Interval Compression Schedule in Newly Diagnosed Patients With Localized Ewing Sarcoma Family of Tumors

Stanford Investigator(s)


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

   - 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


drug: vincristine sulfate

drug: cyclophosphamide

drug: doxorubicin hydrochloride

drug: etoposide

drug: ifosfamide

drug: topotecan hydrochloride

other: radiation therapy

other: therapeutic conventional surgery

biological: filgrastim

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Peds Hem/Onc CRAs

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