Full Text View
Tabular View
No Study Results Posted
Related Studies
Combination Chemotherapy Followed by Bone Marrow and/or Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Medulloblastoma or CNS Germ Cell Tumors
This study has been completed.
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes
Sponsor: Children's Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002594
  Purpose

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

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by bone marrow transplantation and/or peripheral stem cell transplantation in treating patients who have recurrent medulloblastoma or CNS germ cell tumors.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Biological: sargramostim
Drug: cyclophosphamide
Drug: melphalan
Procedure: autologous bone marrow transplantation
Procedure: bone marrow ablation with stem cell support
Procedure: peripheral blood stem cell transplantation
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: DOSE-INTENSIVE MELPHALAN AND CYCLOPHOSPHAMIDE WITH AUTOLOGOUS BONE MARROW RESCUE FOR RECURRENT MEDULLOBLASTOMA AND GERM CELL TUMORS - A PEDIATRIC ONCOLOGY GROUP PILOT STUDY

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 30
Study Start Date: September 1994
Detailed Description:

OBJECTIVES:

  • Determine the response and progression-free survival in patients with recurrent medulloblastoma or CNS germ cell tumors treated with intensive melphalan and cyclophosphamide followed by autologous bone marrow and/or peripheral blood stem cell rescue.
  • Determine the acute and delayed toxic effects of this regimen in these patients.

OUTLINE: Autologous bone marrow and/or peripheral blood stem cells (PBSC) are harvested. Patients then receive intensive cyclophosphamide IV over 1 hour on days -8 to -5 and melphalan IV over 15 minutes on days -4 to -2. Bone marrow is reinfused on day 0. PBSC are reinfused on day 0 if used alone or on day 1 if used after autologous bone marrow transplantation (ABMT). Sargramostim (GM-CSF) is administered IV over 2 hours daily beginning 4 hours after ABMT and continuing until blood counts recover.

Patients are followed every 6 months through year 4 and then annually thereafter.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 2.5 years.

  Eligibility

Ages Eligible for Study:   2 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of recurrent medulloblastoma or CNS germ cell tumor

    • Histologic review of the primary intracranial or spinal cord tumor required

      • Biopsy and reduction of tumor bulk prior to study encouraged but not required
  • No more than 1 prior primary therapy (radiotherapy or chemoradiotherapy) and/or 1 prior salvage therapy

    • Patients with progression on salvage therapy ineligible
  • Minimal residual disease (tumor bulk no more than 1.5 cm) or in second clinical complete remission (CR)
  • Bone marrow infiltration with or without mass lesions or isolated abnormal CSF cytology as the only manifestation of recurrent disease allowed if a clinical CR is first achieved with conventional therapy

PATIENT CHARACTERISTICS:

Age:

  • 2 to 25

Performance status:

  • Karnofsky 80-100%

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 1.5 mg/dL
  • SGPT less than 80 IU

Renal:

  • Creatinine less than 1.2 mg/dL

Cardiovascular:

  • LVEF normal

Other:

  • No infection
  • Able to tolerate vigorous hydration
  • Not pregnant
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics
  • Prior cyclophosphamide or ifosfamide allowed

Endocrine therapy:

  • No concurrent dexamethasone as an antiemetic
  • Other concurrent corticosteroids allowed

Radiotherapy:

  • See Disease Characteristics
  • Pretransplantation radiotherapy boost allowed

Surgery:

  • See Disease Characteristics
  • Pretransplantation surgery allowed

Other:

  • At least 4 weeks since prior therapy except corticosteroids
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002594

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35233
University of South Alabama Medical Center
Mobile, Alabama, United States, 36604
United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Children's Hospital San Diego
San Diego, California, United States, 92123-4282
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States, 95051-5386
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
San Diego, California, United States, 92120
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, United States, 92093-0658
Stanford University Medical Center
Stanford, California, United States, 94305-5208
Sutter Cancer Center
Sacramento, California, United States, 95816
University of California Davis Cancer Center
Sacramento, California, United States, 95817
United States, Connecticut
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States, 06520-8028
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5000
United States, Florida
All Children's Hospital
St. Petersburg, Florida, United States, 33701
Baptist Hospital of Miami
Miami, Florida, United States, 33176-2197
Broward General Medical Center
Fort Lauderdale, Florida, United States, 33316
Children's Hospital of Southwest Florida
Fort Myers, Florida, United States, 33908
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804
Nemours Children's Clinic-Orlando
Orlando, Florida, United States, 32806
Miami Children's Hospital
Miami, Florida, United States, 33155-4069
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Joe DiMaggio Children's Hospital at Memorial
Hollywood, Florida, United States, 33021
Sacred Heart Children's Hospital
Pensacola, Florida, United States, 32504
Shands Hospital and Clinics, University of Florida
Gainesville, Florida, United States, 32610-100277
St. Mary's Hospital
West Palm Beach, Florida, United States, 33407
Sylvester Cancer Center, University of Miami
Miami, Florida, United States, 33136
Tampa Children's Hospital
Tampa, Florida, United States, 33677-4227
United States, Georgia
Children's Healthcare of Atlanta - Scottish Rite
Atlanta, Georgia, United States, 30342
United States, Hawaii
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813
Tripler Army Medical Center
Honolulu, Hawaii, United States, 96859-5000
United States, Illinois
Advocate Hope Children's Hospital
Oak Lawn, Illinois, United States, 60453
Children's Memorial Hospital - Chicago
Chicago, Illinois, United States, 60614
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States, 60612
Saint Jude Midwest Affiliate
Peoria, Illinois, United States, 61637
United States, Kansas
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7357
Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Wesley Medical Center
Wichita, Kansas, United States, 67214
United States, Louisiana
Children's Hospital of New Orleans
New Orleans, Louisiana, United States, 70118
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112
United States, Maine
Eastern Maine Medical Center
Bangor, Maine, United States, 04401
Maine Children's Cancer Program
Scarborough, Maine, United States, 04074-9308
United States, Maryland
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States, 21201-1595
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Floating Hospital for Children
Boston, Massachusetts, United States, 02111
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, United States, 01655
United States, Michigan
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
Hurley Medical Center
Flint, Michigan, United States, 48503
St. John Hospital and Medical Center
Detroit, Michigan, United States, 48236
United States, Mississippi
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, United States, 39534-2511
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
United States, Missouri
Cardinal Glennon Children's Hospital
Saint Louis, Missouri, United States, 63104
University of Missouri-Columbia Hospital and Clinics
Columbia, Missouri, United States, 65212
Washington University Medical Center
Saint Louis, Missouri, United States, 63105
United States, New Hampshire
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New Mexico
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, United States, 87131
United States, New York
Beth Israel Hospital North
New York, New York, United States, 10128
James P. Wilmot Cancer Center
Rochester, New York, United States, 14642
State University of New York - Upstate Medical University
Syracuse, New York, United States, 13210
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Schneider Children's Hospital
New Hyde Park, New York, United States, 11042
Mount Sinai School of Medicine
New York, New York, United States, 10029
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, United States, 11790-7775
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1081
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Presbyterian Healthcare
Charlotte, North Carolina, United States, 28233
Mission St. Joseph's Health System
Asheville, North Carolina, United States, 28801
East Carolina University School of Medicine
Greenville, North Carolina, United States, 27858-4354
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Warren Clinic
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Legacy Emanuel Hospital and Health Center
Portland, Oregon, United States, 97227
United States, Pennsylvania
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134-1095
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02818
United States, South Carolina
Children's Hospital of Greenville Hospital System
Greenville, South Carolina, United States, 29605
Medical University of South Carolina
Charleston, South Carolina, United States, 29425-0721
United States, Tennessee
East Tennessee State University Cancer Center at JCMC
Johnson City, Tennessee, United States, 37604
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105-2794
United States, Texas
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, United States, 76104
Driscoll Children's Hospital
Corpus Christi, Texas, United States, 78466
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Simmons Cancer Center - Dallas
Dallas, Texas, United States, 75235-9154
Scott and White Memorial Hospital
Temple, Texas, United States, 76508
San Antonio Military Pediatric Cancer and Blood Disorders Center
Lackland Air Force Base, Texas, United States, 78236
Texas Children's Cancer Center
Houston, Texas, United States, 77030-2399
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78207
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0361
United States, Vermont
Vermont Cancer Center
Burlington, Vermont, United States, 05401-3498
United States, Virginia
Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
Carilion Medical Center for Children
Roanoke, Virginia, United States, 24029
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042-3300
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States, 22908
Naval Medical Center, Portsmouth
Portsmouth, Virginia, United States, 23708-5100
United States, Washington
Madigan Army Medical Center
Tacoma, Washington, United States, 98431-5000
United States, West Virginia
West Virginia University - Charleston
Charleston, West Virginia, United States, 25302
West Virginia University Hospitals
Morgantown, West Virginia, United States, 26506-9300
United States, Wisconsin
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States, 53226
St. Vincent Hospital
Green Bay, Wisconsin, United States, 54307-9070
Australia, New South Wales
Children's Hospital at Westmead
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Royal Children's Hospital
Brisbane, Queensland, Australia, 4029
Australia, Victoria
Royal Children's Hospital
Parkville, Victoria, Australia, 3052
Canada, Alberta
Alberta Children's Hospital
Calgary, Alberta, Canada, T2T 5C7
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Chedoke-McMaster Hospitals
Hamilton, Ontario, Canada, L8N 3Z5
Canada, Quebec
Centre de Recherche du Centre Hospitalier de l'Universite Laval
Sainte Foy, Quebec, Canada, GIV 4G2
Hopital Sainte Justine
Montreal, Quebec, Canada, H3T 1C5
McGill University Health Center - Montreal Children's Hospital
Montreal, Quebec, Canada, H3G 1A4
Netherlands
Academisch Ziekenhuis Groningen
Groningen, Netherlands, 9700 RB
Puerto Rico
San Jorge Childrens Hospital
Santurce, Puerto Rico, 00912
Switzerland
Swiss Pediatric Oncology Group Bern
Bern, Switzerland, CH 3010
Swiss Pediatric Oncology Group Geneva
Geneva, Switzerland, CH 1211
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Donald H. Mahoney, MD Texas Children's Cancer Center
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000063784, COG-P9430, POG-9430
Study First Received: November 1, 1999
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00002594     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent childhood brain tumor
childhood central nervous system germ cell tumor
recurrent childhood medulloblastoma

Additional relevant MeSH terms:
Melphalan
Neuroectodermal Tumors, Primitive
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Central Nervous System Neoplasms
Cyclophosphamide
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Glioma
Alkylating Agents
Nervous System Neoplasms
Neoplasms by Histologic Type
Nervous System Diseases
Immunosuppressive Agents
Pharmacologic Actions
Neuroectodermal Tumors
Neoplasms
Myeloablative Agonists
Medulloblastoma
Antineoplastic Agents, Alkylating
Neoplasms, Neuroepithelial
Antirheumatic Agents
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009