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Status:

COMPLETED

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

Lead Sponsor:

Children's Oncology Group

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Sarcoma

Eligibility:

All Genders

Up to 49 years

Phase:

PHASE3

Brief Summary

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...

Detailed Description

OBJECTIVES: Primary * Improve the early disease control interval for patients with newly diagnosed, high-risk, metastatic rhabdomyosarcoma or ectomesenchymoma using intensive, interval-compression t...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • 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
  • PATIENT CHARACTERISTICS:
  • 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
  • PRIOR CONCURRENT THERAPY:
  • 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

Exclusion

    Key Trial Info

    Start Date :

    July 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    June 30 2019

    Estimated Enrollment :

    109 Patients enrolled

    Trial Details

    Trial ID

    NCT00354744

    Start Date

    July 1 2006

    End Date

    June 30 2019

    Last Update

    January 29 2020

    Active Locations (166)

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    Page 1 of 42 (166 locations)

    1

    Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham

    Birmingham, Alabama, United States, 35294

    2

    Phoenix Children's Hospital

    Phoenix, Arizona, United States, 85016-7710

    3

    Arizona Cancer Center at University of Arizona Health Sciences Center

    Tucson, Arizona, United States, 85724-5024

    4

    Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, United States, 72205