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A Phase II Study Of Radiation Therapy Plus Low Dose Temozolomide Followed By Temozolomide Plus Irinotecan For Glioblastoma Multiforme


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

A Phase II Study Of Radiation Therapy Plus Low Dose Temozolomide Followed By Temozolomide Plus Irinotecan For Glioblastoma Multiforme


OBJECTIVES:

- Compare overall survival of patients with newly diagnosed supratentorial glioblastoma
multiforme treated with radiotherapy and temozolomide followed by temozolomide and
irinotecan with historical controls from the RTOG database.

- Determine the short- and long-term toxicity of this regimen in these patients.

- Determine progression-free survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

- Chemoradiotherapy: Patients undergo radiotherapy once daily, 5 days a week, for 6
weeks. Concurrently with radiotherapy, patients receive oral temozolomide once daily, 7
days a week, for 6 weeks.

- Post-radiotherapy chemotherapy: Beginning 4-6 weeks after the completion of
chemoradiotherapy, patients receive irinotecan IV on days 1 and 15 and oral
temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 1 year
in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months for 2 years and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 157 patients will be accrued for this study within 11 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed newly diagnosed supratentorial glioblastoma multiforme by
surgical biopsy or excision

- No gliomas graded less than glioblastoma multiforme

- No recurrent malignant gliomas

- No tumor foci below the tentorium or beyond the cranial vault

- Study therapy must begin ≤ 5 weeks after surgery

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Zubrod 0-1

Life expectancy

- At least 8 weeks

Hematopoietic

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 10 g/dL*

- Hematocrit ≥ 30%* NOTE: *Transfusion allowed

Hepatic

- Bilirubin ≤ 0.5 mg/dL

- ALT or AST ≤ 2 times upper limit of normal

Renal

- Creatinine ≤ 1.5 mg/dL

- BUN ≤ 25 mg/dL

Other

- Not pregnant or nursing

- Negative pregnancy test

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

- No AIDS

- No other malignancy within the past 5 years except nonmelanoma skin cancer or
carcinoma in situ of the cervix or bladder

- No other major medical illness or psychiatric impairment that would preclude study
participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No concurrent sargramostim (GM-CSF)

Chemotherapy

- No other concurrent chemotherapy

Endocrine therapy

- Concurrent steroid therapy allowed provided patient is on a stable or decreasing dose
for at least 2 weeks before study entry

Radiotherapy

- No prior radiotherapy to the head or neck resulting in overlap of radiotherapy fields

- Prior radiotherapy for stage T1 glottic cancer allowed

Surgery

- See Disease Characteristics

- Recovered from prior surgery

Other

- No enzyme-inducing antiepileptic drugs within 14 days before the initiation of
irinotecan

- Concurrent non-enzyme-inducing antiepileptic drugs allowed

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Safety Issue:

No

Principal Investigator

Frank S. Lieberman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Pittsburgh

Authority:

United States: Federal Government

Study ID:

CDR0000389229

NCT ID:

NCT00099125

Start Date:

November 2004

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • adult glioblastoma
  • Glioblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Akron City HospitalAkron, Ohio  44304
Roswell Park Cancer InstituteBuffalo, New York  14263
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
University of Chicago Cancer Research CenterChicago, Illinois  60637
Abington Memorial HospitalAbington, Pennsylvania  19001
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Natalie Warren Bryant Cancer Center at St. Francis HospitalTulsa, Oklahoma  74136
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical CenterLa Crosse, Wisconsin  54601
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
CCOP - OchsnerNew Orleans, Louisiana  70121
Rapid City Regional HospitalRapid City, South Dakota  57709
Providence Saint Joseph Medical Center - BurbankBurbank, California  91505
Northwest Community HospitalArlington Heights, Illinois  60005
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
John F. Kennedy Medical CenterEdison, New Jersey  08818
Community Medical CenterToms River, New Jersey  08755
CCOP - ColumbusColumbus, Ohio  43206
Veterans Affairs Medical Center - DaytonDayton, Ohio  45428
Albert Einstein Cancer CenterPhiladelphia, Pennsylvania  19141
Mercy Hospital of PittsburghPittsburgh, Pennsylvania  15219
Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
Dixie Regional Medical CenterSaint George, Utah  84770
LDS HospitalSalt Lake City, Utah  84143
Green Mountain Oncology GroupRutland, Vermont  05701
St. Vincent HospitalGreen Bay, Wisconsin  54307-3508
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Community Memorial HospitalMenomonee Falls, Wisconsin  53051
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Cancer Institute of New Jersey at the Cooper University HospitalCamden, New Jersey  08103-1489
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
UPMC Cancer Center at Magee-Womens HospitalPittsburgh, Pennsylvania  15213-3180
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
Foundation for Cancer Research and EducationPhoenix, Arizona  85013
Monmouth Medical CenterLong Branch, New Jersey  07740-6395
University of New Mexico Cancer Research and Treatment CenterAlbuquerque, New Mexico  87131
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
Cooper Cancer InstituteCamden, New Jersey  08103
Hillman Cancer Center at University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15236
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
Regional Radiation Oncology Center at RomeRome, Georgia  30165
St. Luke's Hospital Cancer CenterBethlehem, Pennsylvania  18015
Loma Linda University Cancer Institute at Loma Linda University Medical CenterLoma Linda, California  92354
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
Mission Hospitals - Memorial CampusAsheville, North Carolina  28801
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Massey Cancer Center at Virginia Commonwealth UniversityRichmond, Virginia  23298-0037
Aultman Hospital Cancer Center at Aultman Health FoundationCanton, Ohio  44710-1799
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Baptist Cancer Institute - JacksonvilleJacksonville, Florida  32207
Cottonwood Hospital Medical CenterMurray, Utah  84107
McKay-Dee Hospital CenterOgden, Utah  84403
Utah Cancer Specialists at UCS Cancer CenterSalt Lake City, Utah  84106
Yale Comprehensive Cancer Center at Yale University School of MedicineNew Haven, Connecticut  06520-8064
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical CenterBoise, Idaho  83706
Ingalls Cancer Care Center at Ingalls Memorial HospitalHarvey, Illinois  60426
Wayne Radiation OncologyGoldsboro, North Carolina  27534
Grandview HospitalDayton, Ohio  45405
David L. Rike Cancer Center at Miami Valley HospitalDayton, Ohio  45409
Charles F. Kettering Memorial HospitalKettering, Ohio  45429
Middletown Regional HospitalMiddletown, Ohio  45044
UVMC Cancer Care Center at Upper Valley Medical CenterTroy, Ohio  45373-1300
Ruth G. McMillan Cancer Center at Greene Memorial HospitalXenia, Ohio  45385
Legacy Mount Hood Medical CenterGresham, Oregon  97030
Providence Milwaukie HospitalMilwaukie, Oregon  97222
Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon  97213-2967
Providence St. Vincent Medical CenterPortland, Oregon  97225
Legacy Meridian Park HospitalTualatin, Oregon  97062
Bryn Mawr HospitalBryn Mawr, Pennsylvania  19010
Lankenau Cancer Center at Lankenau HospitalWynnewood, Pennsylvania  19096
Southwest Washington Medical Center Cancer CenterVancouver, Washington  98668
UPMC St. MargaretPittsburgh, Pennsylvania  15215
Providence Holy Cross Cancer CenterMission Hills, California  91346-9600
Pomona Valley Hospital Medical CenterPomona, California  91767
Radiological Associates of Sacramento Medical Group, Inc.Sacramento, California  95815
St. Francis Hospital and Health CentersBeech Grove, Indiana  46107
Tulane Cancer CenterNew Orleans, Louisiana  70112
Regional Cancer Center at Singing River HospitalPascagoula, Mississippi  39581
Randolph HospitalAsheboro, North Carolina  27203
John Smith, Jr./Dalton McMichael Cancer Center at Morehead Memorial HospitalEden, North Carolina  27288
Moses Cone Regional Cancer Center at Wesley Long Community HospitalGreensboro, North Carolina  27401
Annie Penn Cancer CenterReidsville, North Carolina  27320
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - OxfordSalem, Ohio  44460
Cancer Treatment CenterWooster, Ohio  44691
Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical CenterPortland, Oregon  97210
Institute of Oncology at Vilnius UniversityPortland, Oregon  97227
John and Dorothy Morgan Cancer Center at Lehigh Valley HospitalAllentown, Pennsylvania  18105
Allegheny Cancer Center at Allegheny General HospitalPittsburgh, Pennsylvania  15212
Methodist Cancer Center at Methodist Hospital - OmahaOmaha, Nebraska  68114
Saint Agnes Medical CenterFresno, California  93720-3397
Dartmouth - Hitchcock ConcordConcord, New Hampshire  03301
York Cancer Center at Wellspan HealthYork, Pennsylvania  17403
Community Cancer Center at Rutland Regional Medical CenterRutland, Vermont  05701
Lipson Cancer and Blood Center at Rochester General HospitalRochester, New York  14621
John B. Amos Community Cancer CenterColumbus, Georgia  31902
North Star Lodge Cancer CenterYakima, Washington  98902
UPMC Cancer Center at UPMC PresbyterianPittsburgh, Pennsylvania  15213
Radiation Oncology CenterAlliance, Ohio  44601
Cancer Institute of Cape GirardeauCape Girardeau, Missouri  63703
UPMC Cancer Center - Arnold Palmer PavilionGreensburg, Pennsylvania  15601
UPMC - ShadysidePittsburgh, Pennsylvania  15213-2582
UPMC McKeesportMcKeesport, Pennsylvania  15132
Cancer Center at St. Clair Memorial HospitalPittsburgh, Pennsylvania  15243
UPMC - Passavant HospitalPittsburgh, Pennsylvania  15237