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A Phase I/II Feasibility Study of Oral Etoposide Given Concurrently With Radiotherapy Followed With Dose Intensive Adjuvant Chemotherapy for Children With Newly Diagnosed High Stage Medulloblastoma


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

Thank you

Trial Information

A Phase I/II Feasibility Study of Oral Etoposide Given Concurrently With Radiotherapy Followed With Dose Intensive Adjuvant Chemotherapy for Children With Newly Diagnosed High Stage Medulloblastoma


OBJECTIVES:

- Assess the response rate and toxicity of oral etoposide and radiotherapy in children
with newly diagnosed high stage medulloblastoma.

- Compare the response rate and toxicity of these patients to historical control patients
registered on POG #9031.

- Estimate the 2-year event-free survival and overall survival of these patients.

- Evaluate the toxicity of dose intensive chemotherapy with oral etoposide, cisplatin,
cyclophosphamide, and vincristine following craniospinal irradiation in these patients.

OUTLINE: Patients begin treatment within 1 month of surgery. Patients receive 6 weeks of
radiotherapy to the head and spine, with boosts to the posterior fossa and to sites of
metastasis. Patients also receive 2 courses of oral etoposide once daily for 3 weeks
concurrent with and immediately following radiotherapy (weeks 1-3 and 5-7).

Patients then receive adjuvant chemotherapy consisting of cisplatin IV once every 4 weeks
for 3 courses beginning on week 11, oral etoposide daily for 21 days every 4 weeks for 3
courses (weeks 11, 15, and 19), cyclophosphamide IV on days 1 and 2 with filgrastim (G-CSF)
SQ daily for at least 10 days every 4 weeks for 8 courses (weeks 23-51), and vincristine IV
on days 1, 8, and 15 every 4 weeks for 8 courses (weeks 23-51).

Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months
for 1 year, and annually thereafter.

PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study within about 2
years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically diagnosed advanced (high grade) childhood medulloblastoma

- Residual disease of at least 1.5 cm2 in size on MRI or CT scan OR

- Evidence of CNS or extraneural metastases

PATIENT CHARACTERISTICS:

Age:

- 3 to 21

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- SGPT less than 5 times normal

- Bilirubin less than 1.5 mg/dL

Renal:

- Creatinine less than 1.7 mg/dL OR

- Creatinine clearance greater than 70 mL/min

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy

Endocrine therapy:

- Prior corticosteroids allowed

Radiotherapy:

- No prior radiotherapy

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Albert Moghrabi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Hopital Sainte Justine

Authority:

United States: Federal Government

Study ID:

CDR0000066640

NCT ID:

NCT00003573

Start Date:

November 1998

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • untreated childhood medulloblastoma
  • Medulloblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Baylor College of MedicineHouston, Texas  77030
Arizona Cancer CenterTucson, Arizona  85724
Roswell Park Cancer InstituteBuffalo, New York  14263
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
Emory University Hospital - AtlantaAtlanta, Georgia  30322
Rush-Presbyterian-St. Luke's Medical CenterChicago, Illinois  60612
Johns Hopkins Oncology CenterBaltimore, Maryland  21287
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Washington University School of MedicineSaint Louis, Missouri  63110
University of Rochester Cancer CenterRochester, New York  14642
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
University of California Davis Medical CenterSacramento, California  95817
Shands Hospital and Clinics, University of FloridaGainesville, Florida  32610-100277
Sylvester Cancer Center, University of MiamiMiami, Florida  33136
CCOP - Florida PediatricTampa, Florida  33682-7757
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
Oklahoma Memorial HospitalOklahoma City, Oklahoma  73126-0307
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
University of California San Diego Cancer CenterLa Jolla, California  92093-0658
Marlene & Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
CCOP - Northern New JerseyHackensack, New Jersey  07601
Yale Comprehensive Cancer CenterNew Haven, Connecticut  06520-8028
CCOP - OchsnerNew Orleans, Louisiana  70121
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
Boston Floating Hospital Infants and ChildrenBoston, Massachusetts  02111
Tulane University School of MedicineNew Orleans, Louisiana  70112
CCOP - Columbia River ProgramPortland, Oregon  97213
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
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
MBCCOP - Gulf CoastMobile, Alabama  36688
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
Naval Medical Center - San DiegoSan Diego, California  92134-3202
Eastern Maine Medical CenterBangor, Maine  04401
Hackensack University Medical CenterHackensack, New Jersey  07601
Kaiser Permanente Medical Center - Santa ClaraSanta Clara, California  95051-5386
Nemours Children's ClinicJacksonville, Florida  32207
Miami Children's HospitalMiami, Florida  33155-4069
St. Mary's HospitalWest Palm Beach, Florida  33407
Saint Jude Midwest AffiliatePeoria, Illinois  61637
Via Christi Regional Medical CenterWichita, Kansas  67214
Maine Children's Cancer ProgramScarborough, Maine  04074-9308
University of Missouri-Columbia Hospital and ClinicsColumbia, Missouri  65212
Cardinal Glennon Children's HospitalSaint Louis, Missouri  63104
Schneider Children's HospitalNew Hyde Park, New York  11042
Carolinas Medical CenterCharlotte, North Carolina  28232-2861
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
Cook Children's Medical Center - Fort WorthFort Worth, Texas  76104
Inova Fairfax HospitalFalls Church, Virginia  22042-3300
West Virginia University HospitalsMorgantown, West Virginia  26506-9300
Lucile Packard Children's Hospital at StanfordPalo Alto, California  94304
Hope Children's HospitalOak Lawn, Illinois  60453
Mission Saint Joseph's Health SystemAsheville, North Carolina  28801
Natalie Warren Bryant Cancer CenterTulsa, Oklahoma  74136
Saint Jude Children's Research HospitalMemphis, Tennessee  38105-2794
Children's Hospital and Health CenterSan Diego, California  92123-4282
Children's Memorial Hospital, ChicagoChicago, Illinois  60614
MBCCOP - South Texas PediatricSan Antonio, Texas  78284-7810
Kaiser Permanente-Southern California Permanente Medical GroupSan Diego, California  92120
Scott and White ClinicTemple, Texas  76508
James H. Quillen College of MedicineJohnson City, Tennessee  37614-0622
Carilion Roanoke Community HospitalRoanoke, Virginia  24013
Walt Disney Memorial Cancer InstituteOrlando, Florida  32803
University of New Mexico School of MedicineAlbuquerque, New Mexico  87131
St. John's Hospital and Medical CenterDetroit, Michigan  48236
West Virginia University Medical School-CharlestonCharleston, West Virginia  25304