Combination Chemotherapy in Treating Patients With Non-Metastatic Extracranial Ewing Sarcoma

Not Recruiting

Trial ID: NCT01231906


This trial examined the outcome benefit to patients of adding a new chemotherapy drug combination to the established treatment approach for patients with extracranial Ewing sarcoma, that had not spread from the primary site to other places in the body. The trial randomly assigned patients at the time of study entry to receive established standard treatment with the following 5-drugs: vincristine sulfate, doxorubicin hydrochloride, cyclophosphamide, ifosfamide and etoposide. The outcome for patients receiving the standard 5-drug combination was compared to the outcome for patients who received the same 5-drugs with an additional drug, topotecan hydrochloride delivered in a novel combination with vincristine sulfate and cyclophosphamide.

Official Title

A Phase III Randomized Trial of Adding Vincristine-Topotecan-Cyclophosphamide to Standard Chemotherapy in Initial Treatment of Non-Metastatic Ewing Sarcoma

Stanford Investigator(s)


Inclusion Criteria:

   - Patients with newly diagnosed, biopsy confirmed, extracranial, non-metastatic Ewing
   sarcoma or primitive neuroectodermal tumor (PNET) of bone or soft tissue are eligible
   for this study; note:

      - For the purpose of this study, chest wall tumors with ipsilateral pleural
      effusions, ipsilateral positive pleural fluid cytology or ipsilateral pleural
      based secondary tumor nodules will be considered localized disease

      - Patients with regional node involvement, based on clinical suspicion confirmed by
      pathologic documentation are considered to be non-metastatic

      - Patients with discontinuous osseous lesions within the same bone are considered
      to be non-metastatic

      - Tumors arising in the bony skull (extra-dural) are considered to be extracranial

   - Patient eligibility will be based on a diagnosis of Ewing sarcoma or PNET by
   institutional pathologist

   - No prior chemotherapy or radiation therapy is allowed; patients should only have had a
   biopsy of the primary tumor without an attempt at complete or partial resection;
   patients will still be eligible if unplanned excision was attempted or accomplished as
   long as adequate imaging was obtained prior to surgery

   - Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70mL/min/1.73
   m^2 or serum creatinine based on age/gender as follows:

      - 1 month to < 6 months: 0.4 mg/dL

      - 6 months to < 1 year: 0.5 mg/dL

      - 1 to < 2 years: 0.6 mg/dL

      - 2 to < 6 years: 0.8 mg/dL

      - 6 to < 10 years: 1 mg/dL

      - 10 to < 13 years: 1.2 mg/dL

      - 13 to < 16 years: 1.5 mg/dL (male), 1.4 mg/dL (female)

      - >= 16 years: 1.7 mg/dL (male), 1.4 mg/dL (female)

   - Total bilirubin < 1.5 x upper limit of normal (ULN) for age

   - Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or
   serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x
   upper limit of normal (ULN) for age

   - Shortening fraction of >= 27% by echocardiogram, or ejection fraction of >= 50% by
   radionuclide angiogram

Exclusion Criteria:

   - Patients must have no evidence of metastatic disease; metastatic disease are lesions
   which are discontinuous from the primary tumor, are not regional lymph nodes and do
   not share a body cavity with the primary tumor; if there is any doubt whether lesions
   are metastatic, a biopsy of those lesions should be taken

      - Skeletal lesions in adjacent bones (trans-articular)

      - Contralateral pleural effusion and contralateral pleural nodules

      - Distant lymph node involvement

      - Patients with pulmonary nodules are considered to have metastatic disease if the
      patient has:

         - Solitary nodule > 0.5 cm or multiple nodules of > 0.3 cm unless biopsied and
         negative for Ewing's

         - Biopsies of solitary nodule =< 0.5 cm or multiple nodules =< 0.3 cm are not
         required but if performed and positive indicate metastatic disease

   - Patients whose tumors arise in the dural and intra-dural soft tissues of the cranium
   and spine are not eligible

   - Patients with pathologic diagnoses other than Ewing sarcoma will be excluded

   - Patients diagnosed with Ewing Sarcoma as a second malignant neoplasm are not eligible
   if they have received chemotherapy or radiation for the treatment of their primary

   - Pregnant women will not be entered on this study; pregnancy tests must be obtained in
   female patients who are post-menarchal; lactating females may not participate unless
   they have agreed not to breastfeed their infants; males or females of reproductive
   potential may not participate unless they have agreed to use an effective
   contraceptive method for the duration of the study treatment

   - All patients and/or their parents or legal guardians must sign a written informed

   - All institutional, Food and Drug Administration (FDA), and National Cancer Institute
   (NCI) requirements for human studies must be met


drug: cyclophosphamide

drug: doxorubicin hydrochloride

drug: etoposide

drug: ifosfamide

drug: topotecan hydrochloride

drug: vincristine sulfate

other: laboratory biomarker analysis

drug: Dexrazoxane

Not Recruiting

Contact Information

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

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