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A Phase II Study of Temozolomide in the Treatment of Children With High Grade Glioma


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

Thank you

Trial Information

A Phase II Study of Temozolomide in the Treatment of Children With High Grade Glioma


OBJECTIVES:

- Compare the event-free survival of patients with newly diagnosed anaplastic
astrocytoma, glioblastoma multiforme, gliosarcoma, or diffuse intrinsic pontine glioma
(DIPG) treated with adjuvant temozolomide administered concurrently with postoperative
radiotherapy and then alone as maintenance therapy vs historical control cohorts
treated in prior Pediatric Oncology Group and Children's Cancer Group studies.

- Determine the toxicity of this regimen in these patients.

- Determine the efficacy of this regimen in patients with DIPG.

- Determine the toxicity of this regimen in patients with DIPG.

OUTLINE: This is a multicenter study.

- Adjuvant chemoradiotherapy: Beginning within 6 weeks after surgical resection or
diagnosis*, patients without gross residual disease undergo cranial irradiation 5 days
a week for 6 weeks. Beginning within 6 weeks after surgical resection, patients with
gross residual disease undergo radiotherapy as above followed by boost radiotherapy for
1 week. All patients receive oral temozolomide once daily beginning within 5 days after
initiation of radiotherapy and continuing for a total of 6 weeks in the absence of
disease progression or unacceptable toxicity.

- Adjuvant maintenance therapy: Beginning 4 weeks after completion of adjuvant
chemoradiotherapy, patients receive oral temozolomide on days 1-5. Treatment repeats
every 28 days for a total of 10 courses in the absence of disease progression or
unacceptable toxicity.

NOTE: *For patients with diffuse intrinsic pontine glioma only

Patients are followed every 3-6 months for 4 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 50-60 patients will be accrued for this study within 12-14
months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed newly diagnosed CNS tumor of the following types:

- High grade glioma (HGG) of one of the following histologies:

- Anaplastic astrocytoma (grade III)

- Glioblastoma multiforme (grade IV)

- Gliosarcoma

- Primary spinal cord malignant glioma

- Diffuse intrinsic pontine glioma (DIPG)

- Diagnosed by gadolinium-enhanced MRI

- At least 2/3 of tumor situated in the pons AND tumor clearly originated in
the pons

- No diffuse leptomeningeal disease

- No tumors with features not typical of diffuse intrinsic brainstem glioma,
including any of the following:

- Dorsally exophytic brainstem glioma

- Cervico-medullary junction tumor

- Focal low-grade glioma of the midbrain or brainstem

- No diffuse brainstem enlargement due to neurofibromatosis

- No primary brain stem malignant glioma

- No M+ disease (CSF positive for tumor or metastatic disease)

- Must begin study radiotherapy within 6 weeks after surgical resection (for HGG
patients) or diagnosis (for DIPG patients)

PATIENT CHARACTERISTICS:

Age:

- 3 to 21

Performance status:

- Karnofsky 50-100% OR

- Lansky 50-100%

Life expectancy:

- At least 2 months

Hematopoietic:

- Absolute neutrophil count at least 1,000/mm^3

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

- Hemoglobin at least 10.0 g/dL* NOTE: *Transfusion independent

Hepatic:

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- SGOT or SGPT less than 2.5 times ULN

Renal:

- Creatinine no greater than 1.5 times ULN

Other:

- No other concurrent malignancy

- Concurrent seizure disorder allowed if well controlled on anticonvulsants

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 2 months after
completion of study treatment

PRIOR CONCURRENT THERAPY:

Biologic:

- No concurrent routine cytokine support

Chemotherapy:

- Not specified

Endocrine therapy:

- No concurrent corticosteroids except for increased intracranial pressure in patients
with CNS tumors

Radiotherapy:

- See Disease Characteristics

Surgery:

- See Disease Characteristics

Other:

- No prior therapy for HGG or DIPG

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Improved outcome

Safety Issue:

No

Principal Investigator

Kenneth J. Cohen, MD, MBA

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000069135

NCT ID:

NCT00028795

Start Date:

December 2002

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • childhood brain stem glioma
  • childhood high-grade cerebral astrocytoma
  • childhood spinal cord neoplasm
  • untreated childhood brain stem glioma
  • Astrocytoma
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms
  • Glioblastoma

Name

Location

Baylor College of MedicineHouston, Texas  77030
Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Mayo Clinic Cancer CenterRochester, Minnesota  55905
University of Chicago Cancer Research CenterChicago, Illinois  60637
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Tripler Army Medical CenterHonolulu, Hawaii  96859-5000
Children's Hospital of MichiganDetroit, Michigan  48201
Hurley Medical CenterFlint, Michigan  48503
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
Midwest Children's Cancer CenterMilwaukee, Wisconsin  53226
Yale Comprehensive Cancer CenterNew Haven, Connecticut  06520-8028
Presbyterian - St. Luke's Medical CenterDenver, Colorado  80218
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health CenterFarmington, Connecticut  06360-2875
Baystate Regional Cancer Program at D'Amour Center for Cancer CareSpringfield, Massachusetts  01199
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Bronson Methodist HospitalKalamazoo, Michigan  49007
Natalie Warren Bryant Cancer Center at St. Francis HospitalTulsa, Oklahoma  74136
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Avera Cancer InstituteSioux Falls, South Dakota  57105
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical CenterLa Crosse, Wisconsin  54601
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Lutheran General Cancer Care CenterPark Ridge, Illinois  60068
Newark Beth Israel Medical CenterNewark, New Jersey  07112
New York Medical CollegeValhalla, New York  10595
University of Texas Medical BranchGalveston, Texas  77555-1329
Deaconess Medical CenterSpokane, Washington  99210-0248
St. Vincent HospitalGreen Bay, Wisconsin  54307-3508
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Rush University Medical CenterChicago, Illinois  60612-3824
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
UMASS Memorial Cancer Center - University CampusWorcester, Massachusetts  01605-2982
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Long Island Cancer Center at Stony Brook University HospitalStony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
CCOP - Scott and White HospitalTemple, Texas  76508
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
CCOP - St. Vincent Hospital Cancer Center, Green BayGreen Bay, Wisconsin  54301
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Madigan Army Medical CenterTacoma, Washington  98431-5048
Sutter Cancer CenterSacramento, California  95816
Hackensack University Medical CenterHackensack, New Jersey  07601
Children's Hospital Los AngelesLos Angeles, California  90027-0700
Children's Hospital of Orange CountyOrange, California  92668
Children's National Medical CenterWashington, District of Columbia  20010-2970
Children's Mercy HospitalKansas City, Missouri  64108
St. Joseph's Hospital and Medical CenterPaterson, New Jersey  07503
Children's Hospital of PittsburghPittsburgh, Pennsylvania  15213
Children's Hospital and Regional Medical Center - SeattleSeattle, Washington  98105
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
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
Children's Memorial Hospital - ChicagoChicago, Illinois  60614
Advocate Hope Children's HospitalOak Lawn, Illinois  60453
Saint Jude Midwest AffiliatePeoria, Illinois  61637
Wesley Medical CenterWichita, Kansas  67214
Children's Hospital of New OrleansNew Orleans, Louisiana  70118
Maine Children's Cancer ProgramScarborough, Maine  04074-9308
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
Floating Hospital for ChildrenBoston, Massachusetts  02111
Cardinal Glennon Children's HospitalSaint Louis, Missouri  63104
University of New Mexico Cancer Research and Treatment CenterAlbuquerque, New Mexico  87131
Schneider Children's HospitalNew Hyde Park, New York  11042
St. Christopher's Hospital for ChildrenPhiladelphia, Pennsylvania  19134-1095
Children's Hospital of Greenville Hospital SystemGreenville, South Carolina  29605
St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794
Cook Children's Medical Center - Fort WorthFort Worth, Texas  76104
Inova Fairfax HospitalFalls Church, Virginia  22042-3300
City of Hope Comprehensive Cancer CenterDuarte, California  91010
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Phoenix Children's HospitalPhoenix, Arizona  85016-7710
Southern California Permanente Medical GroupDowney, California  90242
Children's Hospital Central CaliforniaMadera, California  93638-8762
Santa Barbara Cottage HospitalSanta Barbara, California  93102
Medical Center of Central GeorgiaMacon, Georgia  31201
Southern Illinois University School of MedicineSpringfield, Illinois  62794-9658
Kosair Children's HospitalLouisville, Kentucky  40202-3830
St. Louis Children's HospitalSaint Louis, Missouri  63110
Children's Hospital of OmahaOmaha, Nebraska  68114
Brookdale University Hospital and Medical CenterBrooklyn, New York  11212
Brooklyn Hospital CenterBrooklyn, New York  11201
Children's Hospital Medical Center of AkronAkron, Ohio  44308
Children's Medical Center - DaytonDayton, Ohio  45404
St. Vincent Mercy Medical CenterToledo, Ohio  43608
Toledo Children's HospitalToledo, Ohio  43601
Palmetto Health South Carolina Cancer CenterColumbia, South Carolina  29203
East Tennessee Children's HospitalKnoxville, Tennessee  37901
Texas Tech University Health Sciences Center School of MedicineAmarillo, Texas  79106
Children's Hospital of AustinAustin, Texas  78701
Covenant Children's HospitalLubbock, Texas  79410
Children's Hospital of the King's DaughtersNorfolk, Virginia  23507
Bellin Memorial HospitalGreen Bay, Wisconsin  54301
Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, Arizona  85724
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Markey Cancer Center at University of Kentucky Chandler Medical CenterLexington, Kentucky  40536-0084
Tulane Cancer Center at Tulane University Hospital and ClinicNew Orleans, Louisiana  70112
Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, New York  10032
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
St. Vincent Hospitals and Health Care CentersIndianapolis, Indiana  46260
Nevada Cancer Research FoundationLas Vegas, Nevada  89109
SUNY Downstate Medical CenterBrooklyn, New York  11203
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve UniversityCleveland, Ohio  44106
Sioux Valley Hospital and University of South Dakota Medical CenterSioux Falls, South Dakota  57117-5134
Simmons Cancer Center at University of Texas Southwestern Medical Center at DallasDallas, Texas  75390
M.D. Anderson Cancer Center at University of TexasHouston, Texas  77030
Comprehensive Cancer Center at University of Alabama at BirminghamBirmingham, Alabama  35294
Loma Linda University Cancer Institute at Loma Linda University Medical CenterLoma Linda, California  92354
Jonathan Jaques Children's Cancer Center at Miller Children's HospitalLong Beach, California  90801
Children's Hospital and Health Center - San DiegoSan Diego, California  92123-4282
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
Baptist-South Miami Regional Cancer ProgramMiami, Florida  33176
Kaplan Cancer Center at St. Mary's Medical CenterWest Palm Beach, Florida  33407
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
St. Luke's Mountain States Tumor Institute - BoiseBoise, Idaho  83712-6297
Blank Children's HospitalDes Moines, Iowa  50309
Ochsner Cancer Institute at Ochsner Clinic FoundationNew Orleans, Louisiana  70121
Alvin and Lois Lapidus Cancer Institute at Sinai HospitalBaltimore, Maryland  21215
Breslin Cancer Center at Ingham Regional Medical CenterLansing, Michigan  48910
Albert Einstein Cancer Center at Albert Einstein College of MedicineBronx, New York  10461
Mount Sinai Medical CenterNew York, New York  10029
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Mission Hospitals - Memorial CampusAsheville, North Carolina  28801
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Cincinnati Children's Hospital Medical CenterCincinnati, Ohio  45229-3039
Tod Children's Hospital - Forum HealthYoungstown, Ohio  44501
Legacy Emanuel Hospital and Health Center & Children's HospitalPortland, Oregon  97227
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Naval Medical Center - PortsmouthPortsmouth, Virginia  23708-2197
Massey Cancer Center at Virginia Commonwealth UniversityRichmond, Virginia  23298-0037
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston DivisionCharleston, West Virginia  25302
Mary Babb Randolph Cancer Center at West Virginia University HospitalsMorgantown, West Virginia  26506
CCOP - Marshfield Clinic Research FoundationMarshfield, Wisconsin  54449
St. Mary's - Duluth Clinic Cancer CenterDuluth, Minnesota  55805
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Vermont Cancer Center at University of VermontBurlington, Vermont  05405-0075
William Beaumont Hospital - Royal Oak CampusRoyal Oak, Michigan  48073
Group Health Central HospitalSeattle, Washington  98104
Lombardi Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
UNMC Eppley Cancer Center at the University of Nebraska Medical CenterOmaha, Nebraska  68198-7680
New York Weill Cornell Cancer Center at Cornell UniversityNew York, New York  10021
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical CenterLos Angeles, California  90048-1865
Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781
Lucile Packard Children's Hospital at Stanford University Medical CenterPalo Alto, California  95798
Kaiser Permanente Medical Center - Santa Clara Kiely CampusSanta Clara, California  95051-5386
Alfred I. duPont Hospital for ChildrenWilmington, Delaware  19803
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite CampusAtlanta, Georgia  30342
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903
Penn State Children's HospitalHershey, Pennsylvania  17033-0850
Carilion Medical Center for Children at Roanoke Community HospitalRoanoke, Virginia  24014
Mary Bridge Children's Hospital and Health Center - TacomaTacoma, Washington  98405
University of South Alabama Cancer Research InstituteMobile, Alabama  36604
Children's Hospital and Research Center at OaklandOakland, California  94609-1809
Kaiser Permanente Medical Center - SacramentoSacramento, California  95825
Jackson Memorial HospitalMiami, Florida  33136
MBCCOP-Medical College of Georgia Cancer CenterAugusta, Georgia  30912-4000
University of Illinois Medical CenterChicago, Illinois  60612
Riley Children Cancer Center at Riley Hospital for ChildrenIndianapolis, Indiana  46202-5225
Valerie Fund Children's Center at Atlantic HealthSummit, New Jersey  07901
Comprehensive Cancer Center at Maimonides Medical CenterBrooklyn, New York  11219
Dakota Cancer Institute at Innovis Health - Dakota ClinicFargo, North Dakota  58103-4940
Children's Hospital at Oklahoma University Medical CenterOklahoma City, Oklahoma  73104
Doernbecher Children's Hospital at Oregon Health & Science UniversityPortland, Oregon  97239-3098
East Tennessee State University Cancer Center at Johnson City Medical CenterJohnson City, Tennessee  37604
Vanderbilt Children's HospitalNashville, Tennessee  37232-6310
Methodist Cancer Center at Methodist Specialty and Transplant HospitalSan Antonio, Texas  78229-3902
MBCCOP - South Texas PediatricsSan Antonio, Texas  78229-3900
Center for Cancer Prevention and Care at Scott and White ClinicTemple, Texas  76508
Cabell Huntington HospitalHuntington, West Virginia  25701
Chao Family Comprehensive Cancer Center at University of California Irvine Medical CenterOrange, California  92868
General Robert Huyser Cancer Center at David Grant Medical CenterTravis Air Force Base, California  94535
Children's Hospital Cancer CenterDenver, Colorado  80218
St. Joseph's Children's Hospital of TampaTampa, Florida  33677-4227
Pediatric Specialty Clinic at Eastern Maine Medical CenterBangor, Maine  04401
Walter Reed Army Medical CenterSilver Spring, Maryland  20910
DeVos Children's HospitalGrand Rapids, Michigan  49503
Children's Hospitals and Clinics - Minneapolis/St. PaulMinneapolis, Minnesota  55404
University of Missouri - ColumbiaColumbia, Missouri  65203
Children's Hospital at Albany Medical CenterAlbany, New York  12208
Leo W. Jenkins Cancer Center at Pitt County Memorial HospitalGreenville, North Carolina  27858-4354
Columbus Children's HospitalColumbus, Ohio  43205-2696
Huntsman Cancer Institute at University of UtahSalt Lake City, Utah  84112
University of Virginia Cancer CenterCharlottesville, Virginia  22908