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A Pilot Study Using Carboplatin, Vincristine And Temozolomide For Children ≤ 10 Years With Progressive/Symptomatic Low-Grade Gliomas


N/A
N/A
10 Years
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

A Pilot Study Using Carboplatin, Vincristine And Temozolomide For Children ≤ 10 Years With Progressive/Symptomatic Low-Grade Gliomas


OBJECTIVES:

Primary

- Determine the feasibility and toxicity of an induction and maintenance regimen
comprising carboplatin, vincristine, and temozolomide in children with progressive
and/or symptomatic low-grade gliomas.

Secondary

- Determine response rate in patients treated with this regimen.

- Determine 3-year progression-free survival and overall survival of patients treated
with this regimen.

- Correlate response and progression-free survival with the genomic profile of tumors in
patients treated with this regimen.

OUTLINE: This is a pilot study.

- Induction therapy: Patients receive carboplatin IV over 1 hour on days 1, 8, 15, and
22; vincristine IV on days 1, 8, 15, 22, 29, and 36; and oral temozolomide on days
43-47. Four weeks after the completion of induction therapy, patients achieving stable
or responding disease proceed to maintenance therapy.

- Maintenance therapy: Patients receive carboplatin and temozolomide as in induction
therapy and vincristine IV on days 1, 8, and 15. Treatment repeats every 10 weeks for a
total of 6 courses in the absence of disease progression.

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

PROJECTED ACCRUAL: A total of 30-50 patients will be accrued for this study within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed progressive and/or symptomatic low-grade glioma, including
any of the following:

- WHO grade I or II astrocytoma

- Grade I or II oligodendrogliomas

- Mixed oligodendrogliomas

- Gangliogliomas

- Measurable disease

- Progressive and/or symptomatic supratentorial or spinal cord tumors that cannot be
removed for anatomical reasons are allowed

- Optic pathway tumors allowed provided there is evidence of progressive disease by MRI
and/or symptoms of deteriorating vision, progressive hypothalamic/pituitary
dysfunction, or diencephalic syndrome

- Dorsally exophytic brainstem gliomas that were previously resected more than 50% are
allowed provided the residual tumor shows progression (with or without symptoms)

- No diffuse brain stem tumors

- No type 1 neurofibromatosis

PATIENT CHARACTERISTICS:

Age

- 10 and under

Performance status

- ECOG 0-2

- Lansky 50-100%

Life expectancy

- Not specified

Hematopoietic

- Hemoglobin ≥ 8.0 gm/dL

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

- Platelet count ≥ 100,000/mm^3

Hepatic

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

- ALT < 2.5 times ULN

Renal

- Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR

- Creatinine ≤ 0.8 mg/dL (age 5 and under) OR ≤ 1.0 mg/dL (age 6 to10)

Other

- Not pregnant or nursing

- Negative pregnancy test

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No concurrent immunomodulating agents

Chemotherapy

- No other concurrent anticancer chemotherapy

Endocrine therapy

- Prior corticosteroids allowed

- No concurrent corticosteroids except for the treatment of increased intracranial
pressure

Radiotherapy

- Not specified

Surgery

- See Disease Characteristics

- Prior surgery allowed

Other

- No other prior therapy

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Feasibility of delivering this chemotherapy regimen at 24 weeks

Outcome Description:

Feasibility defined as the ability to administer induction plus one maintenance cycle

Outcome Time Frame:

24 weeks

Safety Issue:

No

Principal Investigator

Murali M. Chintagumpala, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Texas Children's Cancer Center

Authority:

United States: Federal Government

Study ID:

ACNS0223

NCT ID:

NCT00077207

Start Date:

July 2004

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • untreated childhood cerebellar astrocytoma
  • untreated childhood visual pathway and hypothalamic glioma
  • childhood spinal cord neoplasm
  • childhood oligodendroglioma
  • childhood low-grade cerebral astrocytoma
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

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
Midwest Children's Cancer CenterMilwaukee, Wisconsin  53226
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health CenterFarmington, Connecticut  06360-2875
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadison, Wisconsin  53792-6164
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
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 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
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
Children's Hospital of New OrleansNew Orleans, Louisiana  70118
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
University of New Mexico Cancer Research and Treatment CenterAlbuquerque, New Mexico  87131
Schneider Children's HospitalNew Hyde Park, New York  11042
St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794
Cook Children's Medical Center - Fort WorthFort Worth, Texas  76104
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
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
Covenant Children's HospitalLubbock, Texas  79410
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
Lee Cancer Care of Lee Memorial Health SystemFort Myers, Florida  33901
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
Nemours Children's Clinic - OrlandoOrlando, Florida  32806
Florida Hospital Cancer Institute at Florida Hospital OrlandoOrlando, Florida  32803-1273
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
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
Advocate Christ Medical CenterOak Lawn, Illinois  60453
St. Vincent Indianapolis HospitalIndianapolis, Indiana  46260
Blank Children's HospitalDes Moines, Iowa  50309
CancerCare of Maine at Eastern Maine Medial CenterBangor, Maine  04401
Floating Hospital for Children at Tufts - New England Medical CenterBoston, Massachusetts  02111
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
Cincinnati Children's Hospital Medical CenterCincinnati, Ohio  45229-3039
Rainbow Babies and Children's HospitalCleveland, Ohio  44106-5000
Legacy Emanuel Hospital and Health Center & Children's HospitalPortland, Oregon  97227
Rhode Island Hospital Comprehensive Cancer CenterProvidence, Rhode Island  02903
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
Methodist Children's Hospital of South TexasSan Antonio, Texas  78229-3993
Providence Cancer Center at Sacred Heart Medical CenterSpokane, Washington  99220-2555
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston DivisionCharleston, West Virginia  25302
Edwards Comprehensive Cancer Center at Cabell Huntington HospitalHuntington, West Virginia  25701
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Childrens Hospital Los AngelesLos Angeles, California  90027
Alfred I. duPont Hospital for ChildrenWilmington, Delaware  19803
Lombardi Comprehensive Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007
Advocate Lutheran General Cancer Care CenterPark Ridge, Illinois  60068-1174
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
Children's Hospitals and Clinics of Minnesota - MinneapolisMinneapolis, Minnesota  55404
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
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
Columbus Children's HospitalColumbus, Ohio  43205-2696
University of Miami Sylvester Comprehensive Cancer Center - MiamiMiami, Florida  33136
Lurleen Wallace Comprehensive Cancer at University of Alabama - BirminghamBirmingham, Alabama  35294
Norris Cotton Cancer Center at Dartmouth - Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
T.C. Thompson Children's HospitalChattanooga, Tennessee  37403
Banner Desert Medical CenterMesa, Arizona  85202
Children's Hospital & Research Center OaklandOakland, California  94609