Clinical Trial: Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Infants With Malignant Brain or Spinal Cord Tumors

This study is no longer recruiting patients.

Sponsors and Collaborators: Children's Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctors to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating infants with malignant brain or spinal cord tumors.

Condition Treatment or Intervention Phase
childhood brain tumor
childhood rhabdoid tumor of the central nervous system
childhood rhabdomyosarcoma
childhood spinal cord tumors
Neuroblastoma
 Drug: carboplatin
 Drug: cisplatin
 Drug: cyclophosphamide
 Drug: etoposide
 Drug: filgrastim
 Drug: thiotepa
 Drug: vincristine
 Procedure: biological response modifier therapy
 Procedure: bone marrow ablation with stem cell support
 Procedure: chemotherapy
 Procedure: colony-stimulating factor therapy
 Procedure: conventional surgery
 Procedure: cytokine therapy
 Procedure: peripheral blood stem cell transplantation
 Procedure: surgery
Phase I

MedlinePlus related topics:  Brain Cancer;   Cancer;   Cancer Alternative Therapy;   Neuroblastoma;   Neurologic Diseases;   Soft Tissue Sarcoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I Pilot Study of Intensive Chemotherapy and Peripheral Blood Stem Cell Rescue in Infants With Malignant Brain or Spinal Cord Tumors

Further Study Details: 

OBJECTIVES:

OUTLINE: This is a pilot, multicenter study.

Patients undergo surgery for diagnosis and maximal tumor resection.

Within 6 weeks of surgery or when stable, patients begin induction chemotherapy comprising cisplatin IV over 6 hours on day 0; vincristine IV on days 0, 7, and 14; cyclophosphamide IV over 1 hour on days 1-2; and etoposide IV over 1 hour on days 0-2. Twenty four hours after the last cyclophosphamide dose, patients receive filgrastim (G-CSF) subcutaneously (SC) and undergo peripheral blood stem cell harvest 2 days later. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Within 6 weeks after induction chemotherapy, patients receive consolidation chemotherapy comprising carboplatin IV over 2 hours on days 0-1 followed immediately by escalating doses of thiotepa IV over 2 hours. Patients then undergo peripheral blood stem cell transplantation 48 hours after the last thiotepa dose. Patients receive G-CSF SC daily on days 3 to 21. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Patients experiencing dose-limiting toxicity due to thiotepa are removed from the study.

Patients are followed at 4 weeks, every 3 months for 1 year, every 6 months for 3 years, and then annually for 3 years or until relapse.

PROJECTED ACCRUAL: A total of 83 patients will be accrued for this study within 1 year.

Eligibility

Ages Eligible for Study:  up to  2 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven malignant brain or spinal cord tumor, including the following:
  • Primitive neuroectodermal tumor
  • Ganglioneuroblastoma
  • Medulloblastoma neuroblastoma
  • Desmoplastic medulloblastoma
  • Medulloepithelioma
  • Ependymoma neuroepithelioma
  • Anaplastic ependymoma germ cell tumor
  • Astrocytoma germinoma
  • Anaplastic astrocytoma
  • Embryonal carcinoma
  • Glioblastoma endodermal sinus tumor
  • Gliosarcoma malignant teratoma
  • Choroid plexus carcinoma
  • Mixed germ cell tumor
  • Cerebellar sarcoma
  • Pineoblastoma
  • Atypical teratoid/rhabdoid tumor
  • Choriocarcinoma
  • Teratoma (malignant or with malignant transformations)
  • Diffusely involved brain stem tumors allowed if there is evidence of brain stem glioma by CT scan or MRI

PATIENT CHARACTERISTICS: Age:

  • 6 months to less than 3 years

Performance Status:

  • Not specified

Life Expectancy:

  • More than 8 weeks

Hematopoietic:

  • Absolute neutrophil count greater than 1,000/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic:

  • Bilirubin less than 2.0 mg/dL

Renal:

  • Glomerular filtration rate or creatinine clearance greater than 70 mL/min

PRIOR CONCURRENT THERAPY: Biologic therapy:

  • No prior biologic therapy

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Prior corticosteroids allowed

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • No more than 6 weeks since prior surgery
  • Recovered from prior surgery (stable)

Location Information


Arizona
      Phoenix Children's Hospital, Phoenix,  Arizona,  85016,  United States

California
      Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center, Los Angeles,  California,  90048,  United States

      Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center, Orange,  California,  92868,  United States

      Children's Hospital and Research Center at Oakland, Oakland,  California,  94609-1809,  United States

      Children's Hospital Central California, Madera,  California,  93638-8762,  United States

      Children's Hospital Los Angeles, Los Angeles,  California,  90027-0700,  United States

      Children's Hospital of Orange County, Orange,  California,  92868,  United States

      City of Hope Comprehensive Cancer Center, Duarte,  California,  91010-3000,  United States

      David Grant Medical Center, Travis Air Force Base,  California,  94535,  United States

      Jonathan Jaques Children's Cancer Center at Miller Children's Hospital, Long Beach,  California,  90801-1428,  United States

      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States

      Kaiser Permanente Medical Center - Sacramento, Sacramento,  California,  95825,  United States

      Loma Linda University Cancer Institute at Loma Linda University Medical Center, Loma Linda,  California,  92354,  United States

      Santa Barbara Cottage Hospital, Santa Barbara,  California,  93102,  United States

      Southern California Permanente Medical Group, Downey,  California,  90242,  United States

      UCSF Comprehensive Cancer Center, San Francisco,  California,  94143,  United States

Colorado
      Children's Hospital of Denver, Denver,  Colorado,  80218-1088,  United States

      Presbyterian - St. Luke's Medical Center, Denver,  Colorado,  80218,  United States

Connecticut
      University of Connecticut Comprehensive Cancer Center at University of Connecticut Health Center, Farmington,  Connecticut,  06360-7106,  United States

Delaware
      Alfred I. duPont Hospital for Children, Wilmington,  Delaware,  19899,  United States

District of Columbia
      Children's National Medical Center, Washington,  District of Columbia,  20010-2970,  United States

      Lombardi Cancer Center at Georgetown University Medical Center, Washington,  District of Columbia,  20007,  United States

Georgia
      Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center, Savannah,  Georgia,  31403-3089,  United States

      MBCCOP-Medical College of Georgia Cancer Center, Augusta,  Georgia,  30912-4000,  United States

      Medical Center of Central Georgia, Macon,  Georgia,  31201,  United States

Idaho
      Mountain States Tumor Institute - Boise, Boise,  Idaho,  83712,  United States

Illinois
      Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood,  Illinois,  60153,  United States

      Lutheran General Cancer Care Center, Park Ridge,  Illinois,  60068-1174,  United States

      Southern Illinois University School of Medicine, Springfield,  Illinois,  62794-9658,  United States

      University of Chicago Cancer Research Center, Chicago,  Illinois,  60601,  United States

      University of Illinois Medical Center, Chicago,  Illinois,  60612,  United States

Indiana
      Riley Children Cancer Center at Riley Hospital for Children, Indianapolis,  Indiana,  46202-5225,  United States

      St. Vincent Hospitals and Health Care Centers, Indianapolis,  Indiana,  46260,  United States

Iowa
      Blank Children's Hospital, Des Moines,  Iowa,  50308,  United States

      Holden Comprehensive Cancer Center at University of Iowa, Iowa City,  Iowa,  52242-1009,  United States

Kentucky
      Kosair Children's Hospital, Louisville,  Kentucky,  40202-3830,  United States

      Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington,  Kentucky,  40536-0284,  United States

Maryland
      Alvin and Lois Lapidus Cancer Institute at Sinai Hospital, Baltimore,  Maryland,  21225,  United States

Massachusetts
      Baystate Regional Cancer Program at Baystate Medical Center, Springfield,  Massachusetts,  01107,  United States

Michigan
      CCOP - Kalamazoo, Kalamazoo,  Michigan,  49007-5364,  United States

      Josephine Ford Cancer Center at Henry Ford Health System, Detroit,  Michigan,  48202,  United States

      Spectrum Health and DeVos Children's Hospital, Grand Rapids,  Michigan,  49503,  United States

      University of Michigan Comprehensive Cancer Center, Ann Arbor,  Michigan,  48109-0914,  United States

      William Beaumont Hospital - Royal Oak, Royal Oak,  Michigan,  48073-6769,  United States

Minnesota
      CCOP - Duluth, Duluth,  Minnesota,  55805,  United States

      Children's Hospitals and Clinics - Minneapolis, Minneapolis,  Minnesota,  55404,  United States

      Children's Hospitals and Clinics - Minnesota, Saint Paul,  Minnesota,  55102,  United States

      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States

      University of Minnesota Cancer Center, Minneapolis,  Minnesota,  55455,  United States

Missouri
      Children's Mercy Hospital, Kansas City,  Missouri,  64108,  United States

Nebraska
      Children's Hospital of Omaha, Omaha,  Nebraska,  68114,  United States

      UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha,  Nebraska,  68198-2168,  United States

Nevada
      Sunrise Hospital and Medical Center, Las Vegas,  Nevada,  89119,  United States

New Jersey
      Cancer Institute of New Jersey at Robert Wood Johnson University Hospital, New Brunswick,  New Jersey,  08903,  United States

      Newark Beth Israel Medical Center, Newark,  New Jersey,  07112-2094,  United States

      St. Barnabas Medical Center, Livingston,  New Jersey,  07039,  United States

      St. Joseph's Hospital and Medical Center, Paterson,  New Jersey,  07503,  United States

      Valerie Fund Children's Center at Atlantic Health, Summit,  New Jersey,  07901,  United States

New York
      Albert Einstein Clinical Cancer Center, Bronx,  New York,  10461,  United States

      Brookdale University Hospital and Medical Center, Brooklyn,  New York,  11212,  United States

      Brooklyn Hospital Center, Brooklyn,  New York,  11201-5493,  United States

      Comprehensive Cancer Center at Maimonides Medical Center, Brooklyn,  New York,  11219,  United States

      Herbert Irving Comprehensive Cancer Center at Columbia University, New York,  New York,  10032,  United States

      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States

      New York Medical College, Valhalla,  New York,  10595,  United States

      New York Weill Cornell Cancer Center at Cornell University, New York,  New York,  10021,  United States

      NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York,  New York,  10016,  United States

      Schneider Children's Hospital, New Hyde Park,  New York,  11042,  United States

      SUNY Downstate Medical Center, Brooklyn,  New York,  11203,  United States

North Carolina
      Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill,  North Carolina,  27599-7295,  United States

North Dakota
      Dakota Cancer Institute at Innovis Health - Dakota Clinic, Fargo,  North Dakota,  58103-4940,  United States

      Meritcare Roger Maris Cancer Center, Fargo,  North Dakota,  58122,  United States

Ohio
      Children's Medical Center - Dayton, Dayton,  Ohio,  45404,  United States

      Cincinnati Children's Hospital Medical Center, Cincinnati,  Ohio,  45229-3039,  United States

      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44195,  United States

      Columbus Children's Hospital, Columbus,  Ohio,  43205-2696,  United States

      Forum Health-Tod Childrens Hospital, Youngstown,  Ohio,  44501,  United States

      Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University, Cleveland,  Ohio,  44106-5065,  United States

      St. Vincent Mercy Medical Center, Toledo,  Ohio,  43608,  United States

      Toledo Children's Hospital, Toledo,  Ohio,  43601,  United States

Oregon
      Doernbecher Children's Hospital at Oregon Health & Science University, Portland,  Oregon,  97239-3098,  United States

Pennsylvania
      Children's Hospital of Philadelphia, Philadelphia,  Pennsylvania,  19104,  United States

      Children's Hospital of Pittsburgh, Pittsburgh,  Pennsylvania,  15213-2583,  United States

      Geisinger Medical Center, Danville,  Pennsylvania,  17822-1320,  United States

      Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey,  Pennsylvania,  17033,  United States

South Carolina
      Palmetto Health South Carolina Cancer Center, Columbia,  South Carolina,  29203,  United States

South Dakota
      Avera Cancer Institute, Sioux Falls,  South Dakota,  57105-1080,  United States

      Sioux Valley Hospital at University of South Dakota Medical Center, Sioux Falls,  South Dakota,  57117-5039,  United States

Tennessee
      East Tennessee Children's Hospital, Knoxville,  Tennessee,  37901,  United States

      Vanderbilt Children's Hospital, Nashville,  Tennessee,  37232-6310,  United States

Texas
      Children's Hospital of Austin, Austin,  Texas,  78701,  United States

      Covenant Children's Hospital, Lubbock,  Texas,  79410,  United States

      MBCCOP - South Texas Pediatrics, San Antonio,  Texas,  78229-3900,  United States

      Methodist Cancer Center at Methodist Specialty and Transplant Hospital, San Antonio,  Texas,  78229-3902,  United States

      Texas Tech University Health Sciences Center School of Medicine, Amarillo,  Texas,  79106,  United States

      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030-4009,  United States

Utah
      Primary Children's Medical Center, Salt Lake City,  Utah,  84113,  United States

Virginia
      Children's Hospital of the King's Daughters, Norfolk,  Virginia,  23507,  United States

Washington
      Children's Hospital and Regional Medical Center - Seattle, Seattle,  Washington,  98105,  United States

      Deaconess Medical Center, Spokane,  Washington,  99210-0248,  United States

      Group Health Eastside Hospital, Redmond,  Washington,  98052,  United States

      Mary Bridge Children's Hospital and Health Center, Tacoma,  Washington,  98415-0299,  United States

West Virginia
      Cabell Huntington Hospital, Huntington,  West Virginia,  25701,  United States

Wisconsin
      Bellin Memorial Hospital, Green Bay,  Wisconsin,  54301,  United States

      Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center, La Crosse,  Wisconsin,  54601,  United States

      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792-6164,  United States

Australia, New South Wales
      Sydney Children's Hospital, Randwick,  New South Wales,  2031,  Australia

Australia, Western Australia
      Princess Margaret Hospital for Children, Perth,  Western Australia,  6006,  Australia

Canada, British Columbia
      British Columbia Children's Hospital, Vancouver,  British Columbia,  V6H 3V4,  Canada

Canada, Manitoba
      CancerCare Manitoba, Winnipeg,  Manitoba,  R3E 0V9,  Canada

Canada, Newfoundland and Labrador
      Janeway Children's Health and Rehabilitation Centre, St. John's,  Newfoundland and Labrador,  A1B 3V6,  Canada

Canada, Ontario
      Children's Hospital of Western Ontario, London,  Ontario,  N6C 2V5,  Canada

Canada, Saskatchewan
      Allan Blair Cancer Centre at Pasqua Hospital, Regina,  Saskatchewan,  S4T 7T1,  Canada

New Zealand
      Starship Children's Health, Auckland,  New Zealand

Study chairs or principal investigators

Bruce H. Cohen, MD,  Study Chair,  Cleveland Clinic Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000065924; COG-99703; CCG-99703; NCT00003141
Record last reviewed:  January 2005
Last Updated:  January 10, 2005
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003141
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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