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A Phase II Study of Concurrent Radiation and Temozolomide Followed By Temozolomide and CCNU 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 Concurrent Radiation and Temozolomide Followed By Temozolomide and CCNU in the Treatment of Children With High-Grade Glioma


OBJECTIVES:

- Compare event-free survival of pediatric patients with newly diagnosed high-grade
gliomas treated with adjuvant radiotherapy and temozolomide followed by temozolomide
and lomustine with historical controls.

- Determine the toxicity of this regimen in these patients.

- Correlate MGMT and p53 expression in tumor tissue with outcome in patients treated with
this regimen.

- Correlate polymorphisms in GSTP1, GSTM1, and GSTT1 genes and GSTP1 protein expression
in tumors with survival in patients treated with this regimen.

OUTLINE: This is a pilot, multicenter study.

- Chemoradiotherapy: Patients receive oral temozolomide once daily on days 1-42. Patients
also undergo concurrent radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33,
and 36-40. Patients who did not undergo prior gross total resection also undergo boost
radiotherapy once daily on days 43-47.

- Maintenance chemotherapy: Four weeks after completion of chemoradiotherapy, patients
receive oral temozolomide once daily on days 1-5 and oral lomustine on day 1. Treatment
repeats every 42 days for up to 6 courses in the absence of disease progression or
unacceptable toxicity.

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

PROJECTED ACCRUAL: A total of 50-100 patients will be accrued for this study within 1-1.5
years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed, newly diagnosed high-grade glioma of 1 of the following
histologies:

- Anaplastic astrocytoma

- Glioblastoma multiforme

- Gliosarcoma

- Primary spinal cord malignant gliomas allowed

- No primary brainstem tumors

- Has undergone surgical resection or biopsy of the tumor within the past 31 days

- Pre-operative and post-operative brain MRI with and without gadolinium-contrast
OR pre-operative and post-operative spine MRI for spinal cord primaries

- Post-operative MRI not required for patients who undergo biopsy only

- No evidence of neuraxis dissemination

- Spine MRI and cerebrospinal fluid cytology required only if clinically indicated

PATIENT CHARACTERISTICS:

Age

- 3 to 21

Performance status

- Karnofsky 50-100% (for patients > 16 years of age)

- Lansky 50-100% (for patients ≤ 16 years of age)

Life expectancy

- At least 8 weeks

Hematopoietic

- Absolute neutrophil count ≥ 1,000/mm^3

- Platelet count ≥ 100,000/mm^3 (transfusion independent)

- Hemoglobin ≥ 8 g/dL (transfusions allowed)

Hepatic

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- ALT ≤ 2.5 times ULN

- Albumin ≥ 2 g/dL

Renal

- Creatinine ≤ 1.5 times ULN OR

- Creatinine clearance or radioisotope glomerular filtration rate ≥ lower limit of
normal

Pulmonary

- No evidence of dyspnea at rest

- No exercise intolerance

- Pulse oximetry ≥ 94% (if determination is clinically indicated)

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 2 months after study
participation

- Able to swallow oral medication

- Seizures allowed provided they are well controlled with anticonvulsants

- No hypersensitivity to temozolomide

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior biologic agents

Chemotherapy

- No prior chemotherapy

Endocrine therapy

- Prior corticosteroids allowed

- No concurrent corticosteroids as an antiemetic

- Concurrent corticosteroids allowed only for treatment of increased intracranial
pressure

Radiotherapy

- No concurrent radiotherapy using cobalt-60

Surgery

- See Disease Characteristics

Other

- No other prior treatment

- No concurrent phenobarbital or cimetidine

- No concurrent co-trimoxazole for Pneumocystis carinii pneumonia prophylaxis during
study chemoradiotherapy

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Event-free survival

Outcome Time Frame:

Time to disease progression, disease relapse, occurence of a second malignant neoplasm, or death from any cause assessed at 1 year

Safety Issue:

No

Principal Investigator

Regina Jakacki, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Children's Hospital of Pittsburgh of UPMC

Authority:

United States: Federal Government

Study ID:

ACNS0423

NCT ID:

NCT00100802

Start Date:

March 2005

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • childhood high-grade cerebral astrocytoma
  • childhood spinal cord neoplasm
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Mayo Clinic Cancer CenterRochester, Minnesota  55905
University of Chicago Cancer Research CenterChicago, Illinois  60637
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Hurley Medical CenterFlint, Michigan  48503
Medical City Dallas HospitalDallas, Texas  75230
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Midwest Children's Cancer CenterMilwaukee, Wisconsin  53226
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health CenterFarmington, Connecticut  06360-2875
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
CCOP - MeritCare HospitalFargo, North Dakota  58122
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Sanford Cancer Center at Sanford USD Medical CenterSioux Falls, South Dakota  57117-5039
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
New York Medical CollegeValhalla, New York  10595
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
CCOP - Scott and White HospitalTemple, Texas  76508
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Sutter Cancer CenterSacramento, California  95816
Children's Hospital of Orange CountyOrange, California  92668
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
University of California Davis Cancer CenterSacramento, California  95817
Miami Children's HospitalMiami, Florida  33155-4069
All Children's HospitalSt. Petersburg, Florida  33701
Children's Memorial Hospital - ChicagoChicago, Illinois  60614
Saint Jude Midwest AffiliatePeoria, Illinois  61637
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
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
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
Inova Fairfax HospitalFalls Church, Virginia  22042-3300
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
Phoenix Children's HospitalPhoenix, Arizona  85016-7710
Southern California Permanente Medical GroupDowney, California  90242
Southern Illinois University School of MedicineSpringfield, Illinois  62794-9658
Kosair Children's HospitalLouisville, Kentucky  40202-3830
Sunrise Hospital and Medical CenterLas Vegas, Nevada  89109-2306
Brooklyn Hospital CenterBrooklyn, New York  11201
Children's Hospital Medical Center of AkronAkron, Ohio  44308
Children's Medical Center - DaytonDayton, Ohio  45404
Palmetto Health South Carolina Cancer CenterColumbia, South Carolina  29203
East Tennessee Children's HospitalKnoxville, Tennessee  37901
Children's Hospital of AustinAustin, Texas  78701
Children's Hospital of the King's DaughtersNorfolk, Virginia  23507
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Markey Cancer Center at University of Kentucky Chandler Medical CenterLexington, Kentucky  40536-0084
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Overlook HospitalSummit, New Jersey  07902-0220
Winthrop University HospitalMineola, New York  11501
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
Kaiser Permanente Medical Center - OaklandSacramento, California  95825
Children's Hospital and Health Center - San DiegoSan Diego, California  92123-4282
Lee Cancer Care of Lee Memorial Health SystemFort Myers, Florida  33901
Broward General Medical Center Cancer CenterFt. Lauderdale, Florida  33316
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
Florida Hospital Cancer Institute at Florida Hospital OrlandoOrlando, Florida  32803-1273
Sacred Heart Cancer Center at Sacred Heart HospitalPensacola, Florida  32504
St. Joseph's Cancer Institute at St. Joseph's HospitalTampa, Florida  33607
Kaplan Cancer Center at St. Mary's Medical CenterWest Palm Beach, Florida  33407
Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322
Advocate Christ Medical CenterOak Lawn, Illinois  60453
St. Vincent Indianapolis HospitalIndianapolis, Indiana  46260
Blank Children's HospitalDes Moines, Iowa  50309
Ochsner Cancer Institute at Ochsner Clinic FoundationNew Orleans, Louisiana  70121
CancerCare of Maine at Eastern Maine Medial CenterBangor, Maine  04401
Breslin Cancer Center at Ingham Regional Medical CenterLansing, Michigan  48910
Hackensack University Medical Center Cancer CenterHackensack, New Jersey  07601
Albert Einstein Cancer Center at Albert Einstein College of MedicineBronx, New York  10461
NYU Cancer Institute at New York University Medical CenterNew York, New York  10016
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Rainbow Babies and Children's HospitalCleveland, Ohio  44106-5000
Toledo HospitalToledo, Ohio  43606
Legacy Emanuel Hospital and Health Center & Children's HospitalPortland, Oregon  97227
Rhode Island Hospital Comprehensive Cancer CenterProvidence, Rhode Island  02903
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Texas Tech University Health Sciences Center School of Medicine - AmarilloAmarillo, Texas  79106
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390
Baylor University Medical Center - HoustonHouston, Texas  77030-2399
Methodist Children's Hospital of South TexasSan Antonio, Texas  78229-3993
Primary Children's Medical CenterSalt Lake City, Utah  84113-1100
Carilion Cancer Center of Western VirginiaRoanoke, Virginia  24029
Providence Cancer Center at Sacred Heart Medical CenterSpokane, Washington  99220-2555
Edwards Comprehensive Cancer Center at Cabell Huntington HospitalHuntington, West Virginia  25701
Saint Peter's University HospitalNew Brunswick, New Jersey  08901-1780
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical CenterLos Angeles, California  90048-1865
Childrens Hospital Los AngelesLos Angeles, California  90027
Alfred I. duPont Hospital for ChildrenWilmington, Delaware  19803
MBCCOP - Medical College of Georgia Cancer CenterAugusta, Georgia  30912-3730
Advocate Lutheran General Cancer Care CenterPark Ridge, Illinois  60068-1174
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
Tulane Cancer Center Office of Clinical ResearchAlexandria, Louisiana  71315-3198
Maine Children's Cancer Program at Barbara Bush Children's HospitalScarborough, Maine  04074-9308
Children's Hospitals and Clinics of Minnesota - MinneapolisMinneapolis, Minnesota  55404
University of Mississippi Cancer ClinicJackson, Mississippi  39216-4505
Children's HospitalOmaha, Nebraska  68114-4113
Albany Medical Center HospitalAlbany, New York  12208-3419
Herbert Irving Comprehensive Cancer Center at Columbia University Medical CenterNew York, New York  10032
Tod Children's HospitalYoungstown, Ohio  44501
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Virginia Commonwealth University Massey Cancer CenterRichmond, Virginia  23298-0037
Madigan Army Medical Center - TacomaTacoma, Washington  98431
Spectrum Health Hospital - Butterworth CampusGrand Rapids, Michigan  49503
Children's Hospital Cancer CenterDenver, Colorado  80218
Columbus Children's HospitalColumbus, Ohio  43205-2696
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Lurleen Wallace Comprehensive Cancer at University of Alabama - BirminghamBirmingham, Alabama  35294
Stanford Comprehensive Cancer Center - StanfordStanford, California  94305
University of Minnesota Children's Hospital - FairviewMinneapolis, Minnesota  55455
Norris Cotton Cancer Center at Dartmouth - Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Memorial Sloan - Kettering Cancer CenterNew York, New York  10021
Children's Hospital & Research Center OaklandOakland, California  94609