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DOSE-INTENSIVE MELPHALAN AND CYCLOPHOSPHAMIDE WITH AUTOLOGOUS BONE MARROW RESCUE FOR RECURRENT MEDULLOBLASTOMA AND GERM CELL TUMORS - A PEDIATRIC ONCOLOGY GROUP PILOT STUDY


Phase 2
2 Years
25 Years
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

DOSE-INTENSIVE MELPHALAN AND CYCLOPHOSPHAMIDE WITH AUTOLOGOUS BONE MARROW RESCUE FOR RECURRENT MEDULLOBLASTOMA AND GERM CELL TUMORS - A PEDIATRIC ONCOLOGY GROUP PILOT STUDY


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Donald H. Mahoney, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Texas Children's Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000063784

NCT ID:

NCT00002594

Start Date:

September 1994

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent childhood brain tumor
  • childhood central nervous system germ cell tumor
  • recurrent childhood medulloblastoma
  • Medulloblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms
  • Neoplasms, Germ Cell and Embryonal

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
Roswell Park Cancer InstituteBuffalo, New York  14263
Stanford University Medical CenterStanford, California  94305-5408
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
Rush-Presbyterian-St. Luke's Medical CenterChicago, Illinois  60612
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
State University of New York Health Sciences Center - Stony BrookStony Brook, New York  11790-7775
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Simmons Cancer Center - DallasDallas, Texas  75235-9154
Shands Hospital and Clinics, University of FloridaGainesville, Florida  32610-100277
Sylvester Cancer Center, University of MiamiMiami, Florida  33136
Tripler Army Medical CenterHonolulu, Hawaii  96859-5000
CCOP - WichitaWichita, Kansas  67214-3882
Children's Hospital of MichiganDetroit, Michigan  48201
Hurley Medical CenterFlint, Michigan  48503
Mount Sinai School of MedicineNew York, New York  10029
Presbyterian HealthcareCharlotte, North Carolina  28233-3549
East Carolina University School of MedicineGreenville, North Carolina  27858-4354
Rhode Island HospitalProvidence, Rhode Island  02903
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
Vermont Cancer CenterBurlington, Vermont  05401-3498
Midwest Children's Cancer CenterMilwaukee, Wisconsin  53226
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
Yale Comprehensive Cancer CenterNew Haven, Connecticut  06520-8028
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Cancer Center at the University of VirginiaCharlottesville, Virginia  22908
Baptist Hospital of MiamiMiami, Florida  33176-2197
Tulane University School of MedicineNew Orleans, Louisiana  70112
University of Texas Medical BranchGalveston, Texas  77555-1329
Naval Medical Center, PortsmouthPortsmouth, Virginia  23708-2197
Massey Cancer CenterRichmond, Virginia  23298-0037
St. Vincent HospitalGreen Bay, Wisconsin  54307-3508
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
University of Kansas Medical CenterKansas City, Kansas  66160-7353
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Keesler Medical Center - Keesler AFBKeesler AFB, Mississippi  39534-2576
Madigan Army Medical CenterTacoma, Washington  98431-5048
Sutter Cancer CenterSacramento, California  95816
Eastern Maine Medical CenterBangor, Maine  04401
Hackensack University Medical CenterHackensack, New Jersey  07601
University of South Alabama Medical CenterMobile, Alabama  36604
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
University of California Davis Cancer CenterSacramento, California  95817
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San DiegoSan Diego, California  92120
Children's Hospital San DiegoSan Diego, California  92123-4282
Kaiser Permanente Medical Center - Santa ClaraSanta Clara, California  95051-5386
Broward General Medical CenterFort Lauderdale, Florida  33316
Children's Hospital of Southwest FloridaFort Myers, Florida  33908
Joe DiMaggio Children's Hospital at MemorialHollywood, Florida  33021
Nemours Children's ClinicJacksonville, Florida  32207
Miami Children's HospitalMiami, Florida  33155-4069
Florida Hospital Cancer InstituteOrlando, Florida  32804
Nemours Children's Clinic-OrlandoOrlando, Florida  32806
Sacred Heart Children's HospitalPensacola, Florida  32504
All Children's HospitalSt. Petersburg, Florida  33701
Tampa Children's HospitalTampa, Florida  33677-4227
St. Mary's HospitalWest Palm Beach, Florida  33407
Children's Healthcare of Atlanta - Scottish RiteAtlanta, Georgia  30342
Children's Memorial Hospital - ChicagoChicago, Illinois  60614
Advocate Hope Children's HospitalOak Lawn, Illinois  60453
Saint Jude Midwest AffiliatePeoria, Illinois  61637
Via Christi Regional Medical CenterWichita, Kansas  67214
Wesley Medical CenterWichita, Kansas  67214
Children's Hospital of New OrleansNew Orleans, Louisiana  70118
Ochsner Clinic FoundationNew Orleans, Louisiana  70121
Maine Children's Cancer ProgramScarborough, Maine  04074-9308
Marlene and Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201-1595
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
Floating Hospital for ChildrenBoston, Massachusetts  02111
University of Massachusetts Memorial Medical Center - University CampusWorcester, Massachusetts  01655
St. John Hospital and Medical CenterDetroit, Michigan  48236
University of Missouri-Columbia Hospital and ClinicsColumbia, Missouri  65212
Cardinal Glennon Children's HospitalSaint Louis, Missouri  63104
Washington University Medical CenterSaint Louis, Missouri  63105
University of New Mexico Cancer Research and Treatment CenterAlbuquerque, New Mexico  87131
Schneider Children's HospitalNew Hyde Park, New York  11042
Beth Israel Hospital NorthNew York, New York  10128
James P. Wilmot Cancer CenterRochester, New York  14642
Mission St. Joseph's Health SystemAsheville, North Carolina  28801
Carolinas Medical CenterCharlotte, North Carolina  28232-2861
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
Warren ClinicTulsa, Oklahoma  74136
Legacy Emanuel Hospital and Health CenterPortland, Oregon  97227
St. Christopher's Hospital for ChildrenPhiladelphia, Pennsylvania  19134-1095
Children's Hospital of Greenville Hospital SystemGreenville, South Carolina  29605
East Tennessee State University Cancer Center at JCMCJohnson City, Tennessee  37604
St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794
Driscoll Children's HospitalCorpus Christi, Texas  78466
Cook Children's Medical Center - Fort WorthFort Worth, Texas  76104
Texas Children's Cancer CenterHouston, Texas  77030-2399
Scott and White Memorial HospitalTemple, Texas  76508
Inova Fairfax HospitalFalls Church, Virginia  22042-3300
Carilion Medical Center for ChildrenRoanoke, Virginia  24029
West Virginia University - CharlestonCharleston, West Virginia  25302
West Virginia University HospitalsMorgantown, West Virginia  26506-9300