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Chemotherapy for Progressive Low Grade Astrocytoma in Children Less Than Ten Years Old


Phase 3
N/A
9 Years
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

Chemotherapy for Progressive Low Grade Astrocytoma in Children Less Than Ten Years Old


OBJECTIVES:

- Compare the event free survival as a result of treatment with carboplatin and
vincristine versus thioguanine, procarbazine, lomustine, and vincristine in children
with progressive brain tumors.

- Estimate tumor response rates to each regimen of chemotherapy in these patients.

- Determine toxic effects and quality of life of children treated with each regimen of
chemotherapy.

- Investigate biological and clinical factors which may predict tumor response and early
progression (tumor size, location, pathologic subtype, cytogenetics, and proliferative
index by MIB-1 (Ki67)) in these patients.

- Investigate factors contributing to neuropsychological and endocrine status of children
with brain tumors treated without irradiation.

OUTLINE: This is a randomized study. Patients are stratified according to site of disease,
status at entry, and pathology. Patients are randomized to one of two treatment arms.
Patients with neurofibromatosis are nonrandomly assigned to arm II.

- Arm I: Patients receive induction with carboplatin and vincristine for 10 weeks
followed by 2 weeks of rest. Induction is followed by 8 courses of maintenance
beginning on day 84 of induction or upon hematopoietic recovery. Each course consists
of 4 weekly doses of carboplatin and 3 weekly doses of vincristine (given concurrently
with the first 3 weeks of carboplatin), followed by 2 weeks of rest.

- Arm II: Patients receive oral thioguanine, procarbazine, and lomustine on days 0-4,
followed by vincristine IV on days 14 and 28. Treatment continues every 6 weeks for a
maximum of 8 courses.

PROJECTED ACCRUAL: A total of 280-340 patients will be accrued over 4 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Pathologically confirmed low grade residual astrocytomas or other eligible residual
tumors of the brain interpreted as low grade (WHO grades I and II) such as the
following:

- Glial Tumors

- Astrocytic tumors

- Low grade astrocytoma (variants: fibrillary, protoplasmic,
gemistocytic)

- Pilocytic astrocytoma

- Pleomorphic xanthoastrocytomas

- Subependymal giant cell astrocytoma

- Infantile desmoplastic astrocytoma

- Low grade oligodendroglial tumors

- Low grade oligodendroglioma

- Low grade mixed gliomas

- Oligo-astrocytoma

- Neuronal Tumors

- Ganglioglioma (excluding tumors with anaplastic astrocytic components)

- Infantile desmoplastic ganglioglioma

- Chiasmatic-hypothalamic tumor without histologic confirmation

- All of the following diagnostic tests (radiological or clinical evidence of
progression, surgery, or confirmatory MRI) must be carried out within 6 weeks of
enrollment into this study

- Progressive disease following surgical excision based on clear radiological or
clinical evidence of progression, or an incomplete excision (less than 95% or greater
than 1.5 cm2) with necessity to begin treatment because of a risk of neurologic
impairment with progression

- Chiasmatic lesions that have contiguous extensions of tumor into other regions of the
visual pathways demonstrated on contrast MRI will be eligible for study without
histopathological confirmation

- Patients with neurofibromatosis who have radiographic diagnosis of
chiasmatic-hypothalamic tumor are eligible for the study, without requiring a biopsy
confirmation of tumor histology, but not unless tumor progression is documented
radiographically

- No intrinsic brain stem tumors of the pons or isolated optic nerve tumors without
definitive involvement of the optic chiasm

PATIENT CHARACTERISTICS:

Age:

- Under 10

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count greater than 1,000/mm^3 (arm II)

- Platelet count greater than 100,000/mm^3 (arm II)

Hepatic:

- Not specified

Renal:

- Creatinine less than 1.5 times upper limit of normal for age OR

- Creatinine clearance or radioisotope GFR greater than 70 mL/min or equivalent GFR as
determined by the institutional normal range

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy for the tumor

Endocrine therapy:

- Prior corticosteroid therapy allowed

Radiotherapy:

- No prior radiotherapy for the tumor

Surgery:

- See Disease Characterisitcs

Other:

- Prior diuretic therapy allowed

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Joann Ater, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000065394

NCT ID:

NCT00002944

Start Date:

April 1997

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent childhood brain stem glioma
  • recurrent childhood visual pathway glioma
  • recurrent childhood cerebellar astrocytoma
  • recurrent childhood cerebral astrocytoma
  • childhood low-grade cerebellar astrocytoma
  • childhood low-grade cerebral astrocytoma
  • Astrocytoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
University of Chicago Cancer Research CenterChicago, Illinois  60637
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
CCOP - WichitaWichita, Kansas  67214-3882
Hurley Medical CenterFlint, Michigan  48503
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
CCOP - KalamazooKalamazoo, Michigan  49007-3731
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
CCOP - DuluthDuluth, Minnesota  55805
CCOP - MeritCare HospitalFargo, North Dakota  58122
Sanford Cancer Center at Sanford USD Medical CenterSioux Falls, South Dakota  57117-5039
Avera Cancer InstituteSioux Falls, South Dakota  57105
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
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
Rush University Medical CenterChicago, Illinois  60612-3824
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Ellis Fischel Cancer Center at University of Missouri - ColumbiaColumbia, Missouri  65203
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
CCOP - Scott and White HospitalTemple, Texas  76508
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Sutter Cancer CenterSacramento, California  95816
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 and Regional Medical Center - SeattleSeattle, Washington  98105
University of California Davis Cancer CenterSacramento, California  95817
Nemours Children's ClinicJacksonville, Florida  32207
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
Wesley Medical CenterWichita, Kansas  67214
Children's Hospital of New OrleansNew Orleans, Louisiana  70118
Cardinal Glennon Children's HospitalSaint Louis, Missouri  63104
Schneider Children's HospitalNew Hyde Park, New York  11042
St. Christopher's Hospital for ChildrenPhiladelphia, Pennsylvania  19134-1095
Driscoll Children's HospitalCorpus Christi, Texas  78466
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
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
Phoenix Children's HospitalPhoenix, Arizona  85016-7710
Southern California Permanente Medical GroupDowney, California  90242
Children's Hospital Central CaliforniaMadera, California  93638-8762
Medical Center of Central GeorgiaMacon, Georgia  31201
Kosair Children's HospitalLouisville, Kentucky  40202-3830
Palmetto Health South Carolina Cancer CenterColumbia, South Carolina  29203
East Tennessee Children's HospitalKnoxville, Tennessee  37901
Covenant Children's HospitalLubbock, Texas  79410
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
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Overlook HospitalSummit, New Jersey  07902-0220
Wilford Hall Medical CenterLackland Air Force Base, Texas  78236-5300
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
Santa Barbara Cottage Children's HospitalSanta Barbara, California  93105
Yale Cancer CenterNew Haven, Connecticut  06520-8028
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
Baptist-South Miami Regional Cancer ProgramMiami, Florida  33176
Nemours Children's Clinic - OrlandoOrlando, Florida  32806
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
St. Vincent Indianapolis HospitalIndianapolis, Indiana  46260
Blank Children's HospitalDes Moines, Iowa  50309
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
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
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
Stony Brook University Cancer CenterStony Brook, New York  11794-8174
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Presbyterian Cancer Center at Presbyterian HospitalCharlotte, North Carolina  28233-3549
Cincinnati Children's Hospital Medical CenterCincinnati, Ohio  45229-3039
Rainbow Babies and Children's HospitalCleveland, Ohio  44106-5000
Medical University of Ohio Cancer CenterToledo, Ohio  43614
Toledo HospitalToledo, Ohio  43606
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Texas Tech University Health Sciences Center School of Medicine - AmarilloAmarillo, Texas  79106
Methodist Children's Hospital of South TexasSan Antonio, Texas  78229-3993
Primary Children's Medical CenterSalt Lake City, Utah  84113-1100
Naval Medical Center - PortsmouthPortsmouth, Virginia  23708-2197
Providence Cancer Center at Sacred Heart Medical CenterSpokane, Washington  99220-2555
Edwards Comprehensive Cancer Center at Cabell Huntington HospitalHuntington, West Virginia  25701
Mary Babb Randolph Cancer Center at West Virginia University HospitalsMorgantown, West Virginia  26506
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
Saint Peter's University HospitalNew Brunswick, New Jersey  08901-1780
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
William Beaumont Hospital - Royal Oak CampusRoyal Oak, Michigan  48073
Group Health Central HospitalSeattle, Washington  98104
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
Memorial Cancer Institute at Memorial Regional HospitalHollywood, Florida  33021
University of South Alabama Mitchell Cancer InstituteMobile, Alabama  36604
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical CenterLos Angeles, California  90048-1865
Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781
Childrens Hospital Los AngelesLos Angeles, California  90027
Children's Hospital and Research Center OaklandOakland, California  94609
Lucile Packard Children's Hospital at Stanford University Medical CenterPalo Alto, California  95798
Rady Children's Hospital - San DiegoSan Diego, California  92123-4282
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
Kaiser Permanente Medical Center - Santa Clara Kiely CampusSanta Clara, California  95051-5386
Children's Hospital Center for Cancer and Blood DisordersAurora, Colorado  80045
Alfred I. duPont Hospital for ChildrenWilmington, Delaware  19803
Lombardi Comprehensive Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007
M.D. Anderson Cancer Center at OrlandoOrlando, Florida  32806
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston CampusAtlanta, Georgia  30322
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite CampusAtlanta, Georgia  30342
MBCCOP - Medical College of Georgia Cancer CenterAugusta, Georgia  30912-3730
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
Mountain States Tumor Institute at St. Luke's Regional Medical CenterBoise, Idaho  83712-6297
University of Illinois Cancer CenterChicago, Illinois  60612-7243
Keyser Family Cancer Center at Advocate Hope Children's HospitalOak Lawn, Illinois  60453
Advocate Lutheran General Cancer Care CenterPark Ridge, Illinois  60068-1174
Swedish-American Regional Cancer CenterRockford, Illinois  61104-2315
Simmons Cooper Cancer InstituteSpringfield, Illinois  62794-9677
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
Lucille P. Markey Cancer Center at University of KentuckyLexington, Kentucky  40536-0093
Tulane Cancer Center Office of Clinical ResearchAlexandria, Louisiana  71315-3198
CancerCare of Maine at Eastern Maine Medical CenterBangor, Maine  04401
Maine Children's Cancer Program at Barbara Bush Children's HospitalScarborough, Maine  04074-9308
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer InstituteBoston, Massachusetts  02115
C.S. Mott Children's Hospital at University of Michigan Medical CenterAnn Arbor, Michigan  48109-0286
Butterworth Hospital at Spectrum HealthGrand Rapids, Michigan  49503-2560
Masonic Cancer Center at University of MinnesotaMinneapolis, Minnesota  55455
Children's Hospitals and Clinics of Minnesota - MinneapolisMinneapolis, Minnesota  55404
Children's Hospitals and Clinics of Minnesota - St. PaulSt. Paul, Minnesota  55102-2392
University of Mississippi Cancer ClinicJackson, Mississippi  39216-4505
Keesler Air Force Base Medical CenterKeesler AFB, Mississippi  39534-2511
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
Children's HospitalOmaha, Nebraska  68114-4113
CCOP - Nevada Cancer Research FoundationLas Vegas, Nevada  89109-2306
St. Barnabas Medical Center Cancer CenterLivingston, New Jersey  07039
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903
University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Albany Medical Center HospitalAlbany, New York  12208-3419
Maimonides Cancer Center at Maimonides Medical CenterBrooklyn, New York  11219
Don Monti Comprehensive Cancer Center at North Shore University HospitalManhasset, New York  11030
Beth Israel Medical Center - Petrie DivisionNew York, New York  10003-3803
Herbert Irving Comprehensive Cancer Center at Columbia University Medical CenterNew York, New York  10032
St. Luke's - Roosevelt Hospital Center - St.Luke's DivisionNew York, New York  10027
Dakota Cancer Institute at Dakota Clinic - South UniversityFargo, North Dakota  58103-4940
Akron Children's HospitalAkron, Ohio  44308-1062
Nationwide Children's HospitalColumbus, Ohio  43205-2696
Dayton Children's - DaytonDayton, Ohio  45404-1815
Tod Children's HospitalYoungstown, Ohio  44501
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Knight Cancer Institute at Oregon Health and Science UniversityPortland, Oregon  97239-3098
Legacy Emanuel Hospital and Health Center and Children's HospitalPortland, Oregon  97227
Geisinger Cancer Institute at Geisinger HealthDanville, Pennsylvania  17822-0001
Penn State Children's HospitalHershey, Pennsylvania  17033-0850
Children's Hospital of Pittsburgh of UPMCPittsburgh, Pennsylvania  15213
Dell Children's Medical Center of Central TexasAustin, Texas  78723
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
Virginia Commonwealth University Massey Cancer CenterRichmond, Virginia  23298-0037
Carilion Medical Center for Children at Roanoke Community HospitalRoanoke, Virginia  24014
Madigan Army Medical Center - TacomaTacoma, Washington  98431
Mary Bridge Children's Hospital and Health Center - TacomaTacoma, Washington  98405
West Virginia University Health Sciences Center - CharlestonCharleston, West Virginia  25302
Gundersen Lutheran Center for Cancer and BloodLa Crosse, Wisconsin  54601