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INTENSIVE THERAPY WITH GROWTH FACTOR SUPPORT FOR PATIENTS WITH EWING'S TUMOR METASTATIC AT DIAGNOSIS: A PEDIATRIC ONCOLOGY GROUP PHASE II STUDY


Phase 2
N/A
30 Years
Not Enrolling
Both
Neutropenia, Sarcoma

Thank you

Trial Information

INTENSIVE THERAPY WITH GROWTH FACTOR SUPPORT FOR PATIENTS WITH EWING'S TUMOR METASTATIC AT DIAGNOSIS: A PEDIATRIC ONCOLOGY GROUP PHASE II STUDY


OBJECTIVES:

I. Evaluate the response rate and duration of response of patients with newly diagnosed,
metastatic Ewing's sarcoma or primitive neuroectodermal tumor treated with maximally
intensified VAdrC (vincristine, doxorubicin, cyclophosphamide) alternating with IE
(ifosfamide, etoposide).

II. Evaluate the response to new agents (first topotecan, then topotecan with
cyclophosphamide) utilized in an upfront treatment window.

III. Assess the role of surgery with regard to local control of primary and metastatic sites
and disease course.

IV. Evaluate whether individual variability in ifosfamide and cyclophosphamide metabolism
correlates with toxicity and/or response.

V. Evaluate the rise in the absolute neutrophil count following one dose of filgrastim
(G-CSF) given immediately prior to a chemotherapy course as an indicator of bone marrow
reserve and subsequent myelosuppression.

VI. Determine if amifostine provides significant chemo-radio protection, particularly
against the cumulative toxicities of this intensive therapy.

OUTLINE: This is a partially randomized, multicenter study.

Patients are treated on the investigational window first or proceed to induction therapy
immediately, if aggressive treatment is necessary.

INVESTIGATIONAL WINDOW: Patients receive cyclophosphamide IV and topotecan IV over 30
minutes on days 1-5. Filgrastim (G-CSF) is administered subcutaneously (SQ) beginning day 6
until blood cell counts recover. Treatment is repeated at week 3.

INDUCTION THERAPY: Patients over 12 months old are randomized to receive amifostine or not.
Patients receive etoposide IV over 45 minutes and ifosfamide IV over 2 hours on days 1-5.
Amifostine IV over 15 minutes is also administered prior to ifosfamide. Patients receive
G-CSF SQ (or IV over 2 hours) beginning on day 6. This course of treatment is administered
on weeks 6, 12, and 18. Patients receive the VAdrC chemotherapy regimen on weeks 9 and 15.
This regimen consists of vincristine IV and amifostine IV over 15 minutes on days 1, 8, and
15, cyclophosphamide IV over 30 minutes and doxorubicin IV over 48 hours on days 1 and 2,
and G-CSF beginning on day 3. The VAdrC regimen is continued during local therapy on weeks
21-29 and 39-47, except the day 15 dose of vincristine is omitted, cyclophosphamide is
administered on day 1 only on weeks 21, 24, 27, 39, 42, and 45, and doxorubicin is replaced
with etoposide IV over 60 minutes on days 1-3 on weeks 24, 28, 42, and 45. Local therapy
begins after 21 weeks of chemotherapy. Patients who respond to chemotherapy and have
resectable disease undergo a complete resection with negative margins. Patients with
unresectable disease or bulky lesions undergo radiotherapy. Some patients may undergo both
surgery and radiotherapy. Local therapy of metastases is delayed until after week 39.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, then annually
thereafter.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Newly diagnosed, pathologically confirmed Ewing's sarcoma or primitive
neuroectodermal tumor (PNET)

- Diagnosis established from biopsy of primary tumor Light microscopy (hematoxylin and
eosin stained) consistent with Ewing's sarcoma or PNET

- No immunohistochemical or ultrastructural characteristics inconsistent with Ewing's
sarcoma or PNET or suggestive of rhabdomyosarcoma

- Metastatic disease required

- Biopsy of radiographically questionable metastases (e.g., pulmonary lesions) required

- Chest wall tumor with separate pleural mass considered metastatic

- No positive pleural fluid cytology alone

PATIENT CHARACTERISTICS:

- Age: 30 and under

- Absolute neutrophil count greater than 1,200/mm3

- Platelet count greater than 120,000/mm3

- Bilirubin less than 1.5 mg/dL

- AST/ALT less than 3 times normal

- Creatinine normal for age

- Significant renal abnormality/disease eligible only if nuclear GFR is normal and
study coordinator approves

- Echocardiogram or MUGA normal

PRIOR CONCURRENT THERAPY:

- No prior chemotherapy or radiotherapy

- Resection at diagnosis is discouraged but does not exclude

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Mark L. Bernstein, MD, FRCPC

Investigator Role:

Study Chair

Investigator Affiliation:

Montreal Children's Hospital at McGill University Health Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-01832

NCT ID:

NCT00002643

Start Date:

April 1995

Completion Date:

Related Keywords:

  • Neutropenia
  • Sarcoma
  • neutropenia
  • metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
  • Neutropenia
  • Neuroectodermal Tumors
  • Neuroectodermal Tumors, Primitive
  • Sarcoma, Ewing's
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Sarcoma

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Kaplan Cancer CenterNew York, New York  10016
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Ireland Cancer CenterCleveland, Ohio  44106-5065
Cancer Center, University of Virginia HSCCharlottesville, Virginia  22908
MBCCOP - LSU Medical CenterNew Orleans, Louisiana  70112
Memorial Mission HospitalAsheville, North Carolina  28801
Medical City Dallas HospitalDallas, Texas  75230
San Antonio Military Pediatric Cancer and Blood Disorders CenterLackland Air Force Base, Texas  78236-5300
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
CCOP - KalamazooKalamazoo, Michigan  49007-3731
Vanderbilt Cancer CenterNashville, Tennessee  37232-6838
CCOP - Merit Care HospitalFargo, North Dakota  58122
Huntsman Cancer InstituteSalt Lake City, Utah  84112
David Grant Medical CenterTravis Air Force Base, California  94535
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Herbert Irving Comprehensive Cancer CenterNew York, New York  10032
Veterans Affairs Medical Center - FargoFargo, North Dakota  58102
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Long Beach Memorial Medical CenterLong Beach, California  90806
Children's Hospital Los AngelesLos Angeles, California  90027-0700
Children's Hospital of Orange CountyOrange, California  92668
Children's Hospital of DenverDenver, Colorado  80218
Children's National Medical CenterWashington, District of Columbia  20010-2970
Children's Hospital Medical Center - CincinnatiCincinnati, Ohio  45229-3039
Children's Hospital of ColumbusColumbus, Ohio  43205-2696
Doernbecher Children's HospitalPortland, Oregon  97201-3098
Children's Hospital of PittsburghPittsburgh, Pennsylvania  15213
Children's Hospital and Regional Medical Center - SeattleSeattle, Washington  98105
Via Christi Regional Medical Center-Saint Francis CampusWichita, Kansas  67214
Children's Mercy Hospital - Kansas CityKansas City, Missouri  64108