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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

Sponsor
Children's Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00002594
Collaborator
National Cancer Institute (NCI) (NIH)
31
Enrollment
118
Locations
1
Arm
149.9
Duration (Months)
0.3
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • 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 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
31 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Dose-Intensive Melphalan and Cyclophosphamide With Autologous Bone Marrow Rescue for Recurrent Medulloblastoma and Germ Cell Tumors
Study Start Date :
Sep 1, 1994
Actual Primary Completion Date :
Sep 1, 2003
Actual Study Completion Date :
Mar 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ablative chemo followed by autologous bone marrow (ABM) rescue

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.

Biological: Sargramostim
Given IV
Other Names:
  • M-CSF
  • GM-CSF
  • Granulocyte macrophage-colony stimulating factor
  • Prokine
  • Leukine
  • NSC #6137

    • Drug: cyclophosphamide
    Given IV
    Other Names:
  • Cytoxan
  • NSC #026271
  • IND #7089

    • Drug: melphalan
    Given IV
    Other Names:
  • ylalanine mustard
  • L-PAM
  • L-sarcolysin
  • Alkeran
  • NSC #8806

    • Procedure: autologous bone marrow transplantation

    Procedure: bone marrow ablation with stem cell support

    Procedure: peripheral blood stem cell transplantation

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free survival [1-2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 25 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Comprehensive Cancer Center Birmingham Alabama United States 35233
    2 University of South Alabama Medical Center Mobile Alabama United States 36604
    3 Arizona Cancer Center Tucson Arizona United States 85724
    4 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
    5 Rebecca and John Moores UCSD Cancer Center La Jolla California United States 92093-0658
    6 Sutter Cancer Center Sacramento California United States 95816
    7 University of California Davis Cancer Center Sacramento California United States 95817
    8 Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego San Diego California United States 92120
    9 Children's Hospital San Diego San Diego California United States 92123-4282
    10 Kaiser Permanente Medical Center - Santa Clara Santa Clara California United States 95051-5386
    11 Stanford University Medical Center Stanford California United States 94305-5208
    12 Yale Comprehensive Cancer Center New Haven Connecticut United States 06520-8028
    13 Walter Reed Army Medical Center Washington District of Columbia United States 20307-5000
    14 Broward General Medical Center Fort Lauderdale Florida United States 33316
    15 Children's Hospital of Southwest Florida Fort Myers Florida United States 33908
    16 Shands Hospital and Clinics, University of Florida Gainesville Florida United States 32610-100277
    17 Joe DiMaggio Children's Hospital at Memorial Hollywood Florida United States 33021
    18 Nemours Children's Clinic Jacksonville Florida United States 32207
    19 Sylvester Cancer Center, University of Miami Miami Florida United States 33136
    20 Miami Children's Hospital Miami Florida United States 33155-4069
    21 Baptist Hospital of Miami Miami Florida United States 33176-2197
    22 Florida Hospital Cancer Institute Orlando Florida United States 32804
    23 Nemours Children's Clinic-Orlando Orlando Florida United States 32806
    24 Sacred Heart Children's Hospital Pensacola Florida United States 32504
    25 All Children's Hospital St. Petersburg Florida United States 33701
    26 Tampa Children's Hospital Tampa Florida United States 33677-4227
    27 St. Mary's Hospital West Palm Beach Florida United States 33407
    28 Children's Healthcare of Atlanta - Scottish Rite Atlanta Georgia United States 30342
    29 Cancer Research Center of Hawaii Honolulu Hawaii United States 96813
    30 Tripler Army Medical Center Honolulu Hawaii United States 96859-5000
    31 Rush-Presbyterian-St. Luke's Medical Center Chicago Illinois United States 60612
    32 Children's Memorial Hospital - Chicago Chicago Illinois United States 60614
    33 Advocate Hope Children's Hospital Oak Lawn Illinois United States 60453
    34 Saint Jude Midwest Affiliate Peoria Illinois United States 61637
    35 University of Kansas Medical Center Kansas City Kansas United States 66160-7357
    36 CCOP - Wichita Wichita Kansas United States 67214-3882
    37 Via Christi Regional Medical Center Wichita Kansas United States 67214
    38 Wesley Medical Center Wichita Kansas United States 67214
    39 MBCCOP - LSU Health Sciences Center New Orleans Louisiana United States 70112
    40 Tulane University School of Medicine New Orleans Louisiana United States 70112
    41 Children's Hospital of New Orleans New Orleans Louisiana United States 70118
    42 Ochsner Clinic Foundation New Orleans Louisiana United States 70121
    43 Eastern Maine Medical Center Bangor Maine United States 04401
    44 Maine Children's Cancer Program Scarborough Maine United States 04074-9308
    45 Marlene and Stewart Greenebaum Cancer Center, University of Maryland Baltimore Maryland United States 21201-1595
    46 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland United States 21231-2410
    47 Floating Hospital for Children Boston Massachusetts United States 02111
    48 Massachusetts General Hospital Cancer Center Boston Massachusetts United States 02114
    49 Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute Boston Massachusetts United States 02115
    50 University of Massachusetts Memorial Medical Center - University Campus Worcester Massachusetts United States 01655
    51 Children's Hospital of Michigan Detroit Michigan United States 48201
    52 St. John Hospital and Medical Center Detroit Michigan United States 48236
    53 Hurley Medical Center Flint Michigan United States 48503
    54 University of Mississippi Medical Center Jackson Mississippi United States 39216-4505
    55 Keesler Medical Center - Keesler AFB Keesler AFB Mississippi United States 39534-2511
    56 University of Missouri-Columbia Hospital and Clinics Columbia Missouri United States 65212
    57 Cardinal Glennon Children's Hospital Saint Louis Missouri United States 63104
    58 Washington University Medical Center Saint Louis Missouri United States 63105
    59 Norris Cotton Cancer Center Lebanon New Hampshire United States 03756-0002
    60 Hackensack University Medical Center Hackensack New Jersey United States 07601
    61 University of New Mexico Cancer Research and Treatment Center Albuquerque New Mexico United States 87131
    62 Roswell Park Cancer Institute Buffalo New York United States 14263-0001
    63 Schneider Children's Hospital New Hyde Park New York United States 11042
    64 Mount Sinai School of Medicine New York New York United States 10029
    65 Beth Israel Hospital North New York New York United States 10128
    66 James P. Wilmot Cancer Center Rochester New York United States 14642
    67 State University of New York Health Sciences Center - Stony Brook Stony Brook New York United States 11790-7775
    68 State University of New York - Upstate Medical University Syracuse New York United States 13210
    69 Mission St. Joseph's Health System Asheville North Carolina United States 28801
    70 Carolinas Medical Center Charlotte North Carolina United States 28232-2861
    71 Presbyterian Healthcare Charlotte North Carolina United States 28233
    72 Duke Comprehensive Cancer Center Durham North Carolina United States 27710
    73 East Carolina University School of Medicine Greenville North Carolina United States 27858-4354
    74 Comprehensive Cancer Center at Wake Forest University Winston-Salem North Carolina United States 27157-1081
    75 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    76 Warren Clinic Tulsa Oklahoma United States 74136
    77 Legacy Emanuel Hospital and Health Center Portland Oregon United States 97227
    78 St. Christopher's Hospital for Children Philadelphia Pennsylvania United States 19134-1095
    79 Rhode Island Hospital Providence Rhode Island United States 02818
    80 Medical University of South Carolina Charleston South Carolina United States 29425-0721
    81 Children's Hospital of Greenville Hospital System Greenville South Carolina United States 29605
    82 East Tennessee State University Cancer Center at JCMC Johnson City Tennessee United States 37604
    83 St. Jude Children's Research Hospital Memphis Tennessee United States 38105-2794
    84 Driscoll Children's Hospital Corpus Christi Texas United States 78466
    85 Medical City Dallas Hospital Dallas Texas United States 75230
    86 Simmons Cancer Center - Dallas Dallas Texas United States 75235-9154
    87 Cook Children's Medical Center - Fort Worth Fort Worth Texas United States 76104
    88 University of Texas Medical Branch Galveston Texas United States 77555-0361
    89 Texas Children's Cancer Center Houston Texas United States 77030-2399
    90 San Antonio Military Pediatric Cancer and Blood Disorders Center Lackland Air Force Base Texas United States 78236
    91 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78207
    92 Scott and White Memorial Hospital Temple Texas United States 76508
    93 Vermont Cancer Center Burlington Vermont United States 05401-3498
    94 Cancer Center at the University of Virginia Charlottesville Virginia United States 22908
    95 Inova Fairfax Hospital Falls Church Virginia United States 22042-3300
    96 Naval Medical Center, Portsmouth Portsmouth Virginia United States 23708-5100
    97 Massey Cancer Center Richmond Virginia United States 23298-0037
    98 Carilion Medical Center for Children Roanoke Virginia United States 24029
    99 Madigan Army Medical Center Tacoma Washington United States 98431-5000
    100 West Virginia University - Charleston Charleston West Virginia United States 25302
    101 West Virginia University Hospitals Morgantown West Virginia United States 26506-9300
    102 St. Vincent Hospital Green Bay Wisconsin United States 54307-9070
    103 Midwest Children's Cancer Center Milwaukee Wisconsin United States 53226
    104 Children's Hospital at Westmead Westmead New South Wales Australia 2145
    105 Royal Children's Hospital Brisbane Queensland Australia 4029
    106 Royal Children's Hospital Parkville Victoria Australia 3052
    107 Alberta Children's Hospital Calgary Alberta Canada T2T 5C7
    108 Cross Cancer Institute Edmonton Alberta Canada T6G 1Z2
    109 Chedoke-McMaster Hospitals Hamilton Ontario Canada L8N 3Z5
    110 Children's Hospital of Eastern Ontario Ottawa Ontario Canada K1H 8L1
    111 Hospital for Sick Children Toronto Ontario Canada M5G 1X8
    112 McGill University Health Center - Montreal Children's Hospital Montreal Quebec Canada H3G 1A4
    113 Hopital Sainte Justine Montreal Quebec Canada H3T 1C5
    114 Centre de Recherche du Centre Hospitalier de l'Universite Laval Sainte Foy Quebec Canada GIV 4G2
    115 Academisch Ziekenhuis Groningen Groningen Netherlands 9700 RB
    116 San Jorge Childrens Hospital Santurce Puerto Rico 00912
    117 Swiss Pediatric Oncology Group Bern Bern Switzerland CH 3010
    118 Swiss Pediatric Oncology Group Geneva Geneva Switzerland CH 1211

    Sponsors and Collaborators

    • Children's Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Donald H. Mahoney, MD, Texas Children's Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Children's Oncology Group
    ClinicalTrials.gov Identifier:
    NCT00002594
    Other Study ID Numbers:
    • 9430
    • COG-P9430
    • POG-9430
    • CDR0000063784
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Jul 24, 2014
    Last Verified:
    Jul 1, 2014
    Keywords provided by Children's Oncology Group
    recurrent childhood brain tumor
    childhood central nervous system germ cell tumor
    recurrent childhood medulloblastoma
    Additional relevant MeSH terms:
    Neoplasms
    Brain Neoplasms
    Neoplasms, Germ Cell and Embryonal
    Nervous System Neoplasms
    Central Nervous System Neoplasms
    Medulloblastoma
    Cyclophosphamide
    Melphalan
    Molgramostim
    Sargramostim

    Study Results

    No Results Posted as of Jul 24, 2014