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A Phase II Study of a Temozolomide-Based Chemoradiotherapy Regimen for High-Risk Low-Grade Gliomas


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

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Trial Information

A Phase II Study of a Temozolomide-Based Chemoradiotherapy Regimen for High-Risk Low-Grade Gliomas


OBJECTIVES:

- Compare the 3-year survival of patients with high-risk low-grade gliomas treated with
temozolomide and radiotherapy followed by temozolomide alone with that of patients
enrolled on European Organization for Research and Treatment of Cancer (EORTC)clinical
trials EORTC-22844 and EORTC-22845.

- Determine the toxicity of this regimen in these patients.

- Determine the association between progression-free survival and O6-methylguanine-DNA
methyltransferase (MGMT) methylation status in patients treated with this regimen.

- Determine the association between survival and MGMT methylation status in patients
treated with this regimen.

- Determine the quality of life (QOL) of patients treated with this regimen.

- Determine the neurocognitive function of patients treated with this regimen.

- Evaluate the feasibility of collecting patient-reported QOL and neurocognitive
assessments over 3 years.

OUTLINE: This is a non-randomized, multicenter study.

Patients receive oral temozolomide once daily on days 1-42 and undergo radiotherapy once
daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning 28 days after completion
of chemoradiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment
with temozolomide repeats every 28 days for up to 12 courses in the absence of disease
progression or unacceptable toxicity.

Quality of life is assessed periodically for up to 36 months.

After completion of study treatment, patients are followed at 4 months, every 6 months for 2
years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 135 patients will be accrued for this study within 44 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed* supratentorial glioma of 1 of the following histologies:

- Astrocytoma (diffuse fibrillary, protoplasmic, or gemistocytic)

- Oligodendroglioma

- Oligoastrocytoma NOTE: *Histologic atypia allowed provided no other histologic
features (i.e., frequent mitoses, endothelial proliferation, and/or acute
necrosis) that would result in a designation of anaplastic astrocytoma,
anaplastic mixed oligodendroglioma or oligoastrocytoma, or glioblastoma
multiforme are present

- Unifocal or multifocal disease

- WHO grade II disease

- Neurofibromatosis allowed

- Surgical biopsy or resection for tumor tissue sampling required within the past 12
weeks

- Tissue block or core biopsy available for O6-methylguanine-DNA methyltransferase
analysis and tissue banking

- Patients who have only had a stereotactic biopsy are not eligible

- Must have ≥ 3 of the following risk factors:

- Age 40 and over

- Largest preoperative tumor diameter ≥ 6 cm

- Tumor crosses the midline

- Astrocytoma-dominant tumor subtype

- Preoperative Neurological Function Status > 1

- No other low-grade glioma histologies, including any of the following:

- Pilocytic astrocytoma

- Subependymal giant cell astrocytoma of tuberous sclerosis

- Subependymoma

- Pleomorphic xanthoastrocytoma

- Presence of a neuronal element, such as ganglioglioma

- Dysneuroembryoplastic epithelial tumor

- No high-grade glioma, including any of the following:

- Anaplastic astrocytoma

- Glioblastoma multiforme

- Anaplastic oligodendroglioma

- Anaplastic oligoastrocytoma

- No tumors in any nonsupratentorial location, including any of the following:

- Optic chiasm

- Optic nerve(s)

- Pons

- Medulla

- Cerebellum

- Spinal cord

- No evidence of disease progression to spinal meninges or noncontiguous cranial
meninges (i.e., leptomeningeal gliomatosis) by MRI of the spine or cerebrospinal
fluid (CSF) cytology

- MRI of the spine or CSF cytology are not required for patients without symptoms
of spinal/cranial meningeal disease progression

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Zubrod 0-2

Life expectancy

- Not specified

Hematopoietic

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

- Platelet count ≥ 100,000/mm^3

Hepatic

- Total bilirubin ≤ 1.5 mg/dL

- Serum glutamate oxaloacetate transaminase (SGOT) or Serum glutamate pyruvate
transaminase (SGPT) ≤ 2 times normal

- Alkaline phosphatase ≤ 2 times normal

Renal

- Serum creatinine ≤ 1.5 mg/dL

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No known HIV positivity

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

- No active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No concurrent immunotherapy or biologic therapy

Chemotherapy

- No prior chemotherapy

- No other concurrent chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- No prior radiotherapy to the head and neck unless head and neck radiotherapy clearly
excluded the brain (e.g., localized radiotherapy to the vocal cords)

- No prior radiotherapy to the brain

- No concurrent intensity modulated radiotherapy

- No concurrent stereotactic boost radiotherapy

Surgery

- See Disease Characteristics

Other

- No other concurrent investigational agents

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival at 3 years.

Outcome Time Frame:

Death of last follow-up. Analysis occurs after all patients have been potentially followed for 3 years

Safety Issue:

No

Principal Investigator

Barbara J. Fisher, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

London Regional Cancer Program at London Health Sciences Centre

Authority:

United States: Federal Government

Study ID:

RTOG 0424

NCT ID:

NCT00114140

Start Date:

January 2005

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult diffuse astrocytoma
  • adult oligodendroglioma
  • adult mixed glioma
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
University of Chicago Cancer Research CenterChicago, Illinois  60637
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
Aultman Cancer Center at Aultman HospitalCanton, Ohio  44710-1799
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
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
Rapid City Regional HospitalRapid City, South Dakota  57709
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
Mission Hospitals - Memorial CampusAsheville, North Carolina  28801
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54301-3526
Bay Area Cancer Care Center at Bay Area Medical CenterMarinette, Wisconsin  54143
Baptist Cancer Institute - JacksonvilleJacksonville, Florida  32207
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
Gundersen Lutheran Center for Cancer and BloodLa Crosse, Wisconsin  54601
Methodist Estabrook Cancer CenterOmaha, Nebraska  68114-4199
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical CenterColumbus, Ohio  43210-1240
Rosenfeld Cancer Center at Abington Memorial HospitalAbington, Pennsylvania  19001
Dixie Regional Medical Center - East CampusSaint George, Utah  84770
DeCesaris Cancer Institute at Anne Arundel Medical CenterAnnapolis, Maryland  21401
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - OxfordSalem, Ohio  44460
Cancer Treatment CenterWooster, Ohio  44691
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
Jon and Karen Huntsman Cancer Center at Intermountain Medical CenterMurray, Utah  84157
Arizona Oncology Services FoundationPhoenix, Arizona  85013
Integrated Community Oncology NetworkJacksonville Beach, Florida  32250
Baptist Medical Center SouthJascksonville, Florida  32258
Florida Cancer Center - PalatkaPalatka, Florida  32177
Flagler Cancer CenterSaint Augustine, Florida  32086
Integrated Community Oncology Network - Orange ParkOrange Park, Florida  32073
Integrated Community Oncology Network at Southside Cancer CenterJacksonville, Florida  32207