High-Dose Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Metastatic Rhabdomyosarcoma or Ectomesenchymoma

Not Recruiting

Trial ID: NCT00354744


RATIONALE: Drugs used in chemotherapy, such as vincristine, irinotecan, ifosfamide, etoposide, doxorubicin, cyclophosphamide, and dactinomycin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving high-dose combination chemotherapy together with radiation therapy may kill more tumor cells. PURPOSE: This phase III trial is studying how well giving high-dose combination chemotherapy together with radiation therapy works in treating patients with newly diagnosed metastatic rhabdomyosarcoma or ectomesenchymoma.

Official Title

Intensive Multi-Agent Therapy, Including Dose-Compressed Cycles of Ifosfamide/Etoposide (IE) and Vincristine/Doxorubicin/Cyclophosphamide (VDC) for Patients With High-Risk Rhabdomyosarcoma

Stanford Investigator(s)



   - Histologically confirmed high-risk rhabdomyosarcoma or ectomesenchymoma

      - Prior enrollment on COG-D9902 to confirm local histological diagnosis required

         - Tissue must be submitted for pathologic review within 2 days of patient
         registration on COG-D9902

      - Newly diagnosed disease

      - Metastatic disease (stage IV, clinical group IV)

   - Has undergone initial surgical procedure (including biopsy) that provided the
   definitive diagnosis within the past 42 days

   - Parameningeal and paraspinal tumors allowed

      - Patients with parameningeal (without intracranial extension [ICE]) and paraspinal
      tumors should begin study chemotherapy at week 1 and radiotherapy at week 20

   - Patients with evidence of ICE, as defined by contrast MRI showing that primary tumor
   touches, displaces, invades, distorts, or otherwise causes a signal abnormality of the
   dura in contiguity to the primary site in brain or spinal cord, are eligible

      - ICE is presumed to exist if the cerebrospinal fluid cytopathology is positive for
      tumor at diagnosis

   - Patients requiring emergency radiotherapy are eligible

      - Patients requiring emergency radiotherapy (for intracranial extension or spinal
      cord impingement) should begin study chemotherapy at week 1 (irinotecan
      hydrochloride and vincristine) concurrently with radiation therapy


   - ECOG or Zubrod performance status (PS) 0-2 (Lansky PS 50-100% for patients < 10 years
   of age and Karnofsky PS 50-100% for patients ≥ 10 years of age)

   - Absolute neutrophil count ≥ 750/mm³*

   - Platelet count ≥ 75,000/mm³*

   - Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min (≥ 40
   mL/min for infants < 1 year of age)

   - Patients with urinary tract obstruction by tumor must meet the renal function criteria
   listed above AND must have unimpeded urinary flow established via decompression of the
   obstructed portion of the urinary tract

   - SGPT < 2.5 times normal

   - Bilirubin < 1.5 mg/dL

   - Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by MUGA

   - Not pregnant or nursing

   - Negative pregnancy test

   - Fertile patients must use effective contraception during study and for ≥ 1 month after
   study completion

   - No evidence of uncontrolled infection

   - Able to undergo radiotherapy NOTE: *Abnormal blood counts allowed if there is bone
   marrow biopsy or aspirate proven bone marrow involvement by rhabdomyosarcoma


   - No prior chemotherapy except steroids

   - No prior radiotherapy

   - No concurrent aprepitant during ifosfamide or doxorubicin hydrochloride chemotherapy

   - No concurrent dexrazoxane

   - No concurrent sargramostim (GM-CSF) or pegfilgrastim


biological: dactinomycin

drug: vincristine sulfate

radiation: radiation therapy

drug: cyclophosphamide

drug: doxorubicin hydrochloride

drug: etoposide

drug: ifosfamide

drug: irinotecan hydrochloride

procedure: conventional surgery

biological: filgrastim

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Min Wang

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