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Combination Chemotherapy Followed by Bone Marrow and/or Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Medulloblastoma or CNS Germ Cell Tumors Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Combination Chemotherapy Followed by Bone Marrow and/or Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Medulloblastoma or CNS Germ Cell Tumors conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Combination Chemotherapy Followed by Bone Marrow and/or Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Medulloblastoma or CNS Germ Cell Tumors Clinical research trials and Combination Chemotherapy Followed by Bone Marrow and/or Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Medulloblastoma or CNS Germ Cell Tumors medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Combination Chemotherapy Followed by Bone Marrow and/or Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Medulloblastoma or CNS Germ Cell Tumors. Combination Chemotherapy Followed by Bone Marrow and/or Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Medulloblastoma or CNS Germ Cell Tumors Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Combination Chemotherapy Followed by Bone Marrow and/or Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Medulloblastoma or CNS Germ Cell Tumors clinical trial. Subjects typically recieve the finest healthcare available for their Combination Chemotherapy Followed by Bone Marrow and/or Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Medulloblastoma or CNS Germ Cell Tumors condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Followed by Bone Marrow and/or Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Medulloblastoma or CNS Germ Cell Tumors Combination Chemotherapy Followed by Bone Marrow and/or Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Medulloblastoma or CNS Germ Cell Tumors
Combination Chemotherapy Followed by Bone Marrow and/or Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Medulloblastoma or CNS Germ Cell Tumors
For Condition: recurrent childhood brain tumor,childhood central nervous system germ cell tumor,recurrent childhood medulloblastoma
Status: No longer recruiting
Sponsor(s): Children's Oncology Group , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 2 Years/25 Years
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DonaldMahoney, Study Chair, Texas Children's Cancer Center
Children's Memorial Hospital - Chicago
Chicago, Illinois, 60614
United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498
United States
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655
United States
University of Texas Medical Branch
Galveston, Texas, 77555-0361
United States
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
Canada
Children's Hospital of New Orleans
New Orleans, Louisiana, 70118
United States
Washington University Medical Center
St. Louis, Missouri, 63105
United States
West Virginia University Hospitals
Morgantown, West Virginia, 26506-9300
United States
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
San Diego, California, 92120
United States
Miami Children's Hospital
Miami, Florida, 33155-4069
United States
Presbyterian Healthcare
Charlotte, North Carolina, 28233
United States
Medical City Dallas Hospital
Dallas, Texas, 75230
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
James P. Wilmot Cancer Center
Rochester, New York, 14642
United States
Via Christi Regional Medical Center
Wichita, Kansas, 67214
United States
Advocate Hope Children's Hospital
Oak Lawn, Illinois, 60453
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160-7357
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
Warren Clinic
Tulsa, Oklahoma, 74136
United States
Cardinal Glennon Children's Hospital
St. Louis, Missouri, 63104
United States
Stanford University Medical Center
Stanford, California, 94305-5208
United States
East Tennessee State University Cancer Center at JCMC
Johnson City, Tennessee, 37604
United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, 53226
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756-0002
United States
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105-2794
United States
Carolinas Medical Center
Charlotte, North Carolina, 28232-2861
United States
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Canada
East Carolina University School of Medicine
Greenville, North Carolina, 27858-4354
United States
Yale Comprehensive Cancer Center
New Haven, Connecticut, 06520-8028
United States
Scott and White Memorial Hospital
Temple, Texas, 76508
United States
Driscoll Children's Hospital
Corpus Christi, Texas, 78466
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78207
United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, 11790-7775
United States
Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Alberta Children's Hospital
Calgary, Alberta, T2T 5C7
Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Canada
Children's Hospital of Michigan
Detroit, Michigan, 48201
United States
Maine Children's Cancer Program
Scarborough, Maine, 04074-9308
United States
Beth Israel Hospital North
New York City, New York, 10128
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
Floating Hospital for Children
Boston, Massachusetts, 02111
United States
San Jorge Childrens Hospital
Santurce, , 00912
Puerto Rico
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35233
United States
Broward General Medical Center
Ft. Lauderdale, Florida, 33316
United States
Joe DiMaggio Children's Hospital at Memorial
Hollywood, Florida, 33021
United States
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, 87131
United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
United States
Tripler Army Medical Center
Honolulu, Hawaii, 96859-5000
United States
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134-1095
United States
Inova Fairfax Hospital
Falls Church, Virginia, 22042-3300
United States
University of South Alabama Medical Center
Mobile, Alabama, 36604
United States
Children's Hospital of Southwest Florida
Ft. Myers, Florida, 33908
United States
Swiss Pediatric Oncology Group Geneva
Geneva, , CH 1211
Switzerland
Legacy Emanuel Hospital and Health Center
Portland, Oregon, 97227
United States
Wesley Medical Center
Wichita, Kansas, 67214
United States
Mount Sinai School of Medicine
New York City, New York, 10029
United States
Rhode Island Hospital
Providence, Rhode Island, 02818
United States
Chedoke-McMaster Hospitals
Hamilton, Ontario, L8N 3Z5
Canada
Shands Hospital and Clinics, University of Florida
Gainesville, Florida, 32610-100277
United States
West Virginia University - Charleston
Charleston, West Virginia, 25302
United States
University of Missouri-Columbia Hospital and Clinics
Columbia, Missouri, 65212
United States
McGill University Health Center - Montreal Children's Hospital
Montreal, Quebec, H3G 1A4
Canada
Nemours Children's Clinic
Jacksonville, Florida, 32207
United States
University of California Davis Cancer Center
Sacramento, California, 95817
United States
Centre de Recherche du Centre Hospitalier de l'Universite Laval
Sainte-Foy, Quebec, GIV 4G2
Canada
Baptist Hospital of Miami
Miami, Florida, 33176-2197
United States
Eastern Maine Medical Center
Bangor, Maine, 04401
United States
Children's Hospital at Westmead
Westmead, New South Wales, 2145
Australia
Florida Hospital Cancer Institute
Orlando, Florida, 32804
United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813
United States
Hopital Sainte Justine
Montreal, Quebec, H3T 1C5
Canada
Naval Medical Center, Portsmouth
Portsmouth, Virginia, 23708-5100
United States
Carilion Medical Center for Children
Roanoke, Virginia, 24029
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
Schneider Children's Hospital
New Hyde Park, New York, 11042
United States
St. Mary's Hospital
West Palm Beach, Florida, 33407
United States
Madigan Army Medical Center
Tacoma, Washington, 98431-5000
United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051-5386
United States
Sutter Cancer Center
Sacramento, California, 95816
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Nemours Children's Clinic-Orlando
Orlando, Florida, 32806
United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612
United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908
United States
Children's Healthcare of Atlanta - Scottish Rite
Atlanta, Georgia, 30342
United States
St. John Hospital and Medical Center
Detroit, Michigan, 48236
United States
Texas Children's Cancer Center
Houston, Texas, 77030-2399
United States
Swiss Pediatric Oncology Group Bern
BERN, , CH 3010
Switzerland
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
San Antonio Military Pediatric Cancer and Blood Disorders Center
Lackland Air Force Base, Texas, 78236
United States
Rebecca and John Moores UCSD Cancer Center
La Jolla, California, 92093-0658
United States
Tampa Children's Hospital
Tampa, Florida, 33677-4227
United States
Children's Hospital San Diego
San Diego, California, 92123-4282
United States
Sylvester Cancer Center, University of Miami
Miami, Florida, 33136
United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1081
United States
Arizona Cancer Center
Tucson, Arizona, 85724
United States
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, 39534-2511
United States
Mission St. Joseph's Health System
Asheville, North Carolina, 28801
United States
Cook Children's Medical Center - Fort Worth
Ft. Worth, Texas, 76104
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
All Children's Hospital
St. Petersburg, Florida, 33701
United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201-1595
United States
Academisch Ziekenhuis Groningen
Groningen, , 9700 RB
Netherlands
Saint Jude Midwest Affiliate
Peoria, Illinois, 61637
United States
St. Vincent Hospital
Green Bay, Wisconsin, 54307-9070
United States
Sacred Heart Children's Hospital
Pensacola, Florida, 32504
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
United States
Hurley Medical Center
Flint, Michigan, 48503
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
Children's Hospital of Greenville Hospital System
Greenville, South Carolina, 29605
United States
Royal Children's Hospital
Brisbane, Queensland, 4029
Australia
Royal Children's Hospital
Parkville, Victoria, 3052
Australia
Additional Information:
Study ID Numbers: CDR0000063784; COG-P9430,POG-9430
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002594
Other Recurrent Childhood Medulloblastoma Studies:
1. Docetaxel in Treating Children With Recurrent Solid Tumors
2. O6-benzylguanine and Carmustine in Treating Children With Refractory CNS Tumors
3. Oxaliplatin in Treating Children With Recurrent or Refractory Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor
4. Combination Chemotherapy Followed by Bone Marrow and/or Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Medulloblastoma or CNS Germ Cell Tumors
5. Combination Chemotherapy, Surgery or Radiation Therapy, and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Medulloblastoma or Primitive Neuroectodermal and Pineal Tumors
Related Studies:
Other recurrent childhood medulloblastoma Clinical Trials
Other New York Clinical Trials
Other Stony Brook Clinical Trials
Combination Chemotherapy Followed by Bone Marrow and/or Peripheral Stem Cell Transplantation in Treating Patients With Recurrent Medulloblastoma or CNS Germ Cell Tumors
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