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A Phase II Trial Of Pre-Irradiation And Concurrent Temozolomide In Patients With Newly Diagnosed Anaplastic Oligodendrogliomas And Mixed Anaplastic Oligoastrocytomas


Phase 2
18 Years
65 Years
Open (Enrolling)
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

A Phase II Trial Of Pre-Irradiation And Concurrent Temozolomide In Patients With Newly Diagnosed Anaplastic Oligodendrogliomas And Mixed Anaplastic Oligoastrocytomas


OBJECTIVES:

- Determine the rate of progression in patients with newly diagnosed anaplastic
oligodendrogliomas or mixed anaplastic oligoastrocytomas treated with neoadjuvant and
concurrent temozolomide with radiotherapy.

- Determine the toxicity of this regimen in these patients.

- Determine the survival of patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified according to response to
neoadjuvant temozolomide (stable disease or partial response [PR] vs complete response
[CR]).

Patients receive oral temozolomide on days 1-7 and 15-21. Treatment repeats every 28 days
for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients
with CR or PR receive 2 courses beyond CR or PR.

Within 6 weeks after completion of neoadjuvant temozolomide, patients with stable disease or
PR undergo radiotherapy 5 days a week for 6.5 weeks. Patients also receive oral temozolomide
daily for 42 days concurrently with radiotherapy.

Patients with CR after completion of neoadjuvant temozolomide undergo observation.

Patients are followed at 9 and 12 months, every 4 months for 1 year, every 6 months for 3
years, and then annually thereafter.

PROJECTED ACCRUAL: A maximum of 37 patients will be accrued for this study within 12 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed supratentorial pure or mixed anaplastic
oligodendroglioma

- Unifocal or multifocal disease

- Prior suspected or proven low-grade glioma eligible provided biopsy reveals pure
or mixed anaplastic oligodendroglioma that has not been previously treated with
radiotherapy and/or chemotherapy

- No equivocal oligodendroglial element

- No tumors predominantly located in the posterior fossa (i.e., brainstem or
cerebellum)

- No spinal cord tumors

- No evidence of spinal drop metastasis or spread to noncontiguous meninges

PATIENT CHARACTERISTICS:

Age:

- 18 to 65

Performance status:

- Zubrod 0-1

Life expectancy:

- More than 12 weeks

Hematopoietic:

- Absolute granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 10 g/dL

Hepatic:

- Bilirubin no greater than 2 times normal

- AST no greater than 3 times normal

- Alkaline phosphatase no greater than 2 times normal

Renal:

- Creatinine no greater than 1.5 times normal

Other:

- No active infection

- No other medical problems that would preclude study participation

- No other malignancy within the past 3 years except carcinoma in situ of the cervix or
nonmelanoma skin cancer

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- See Disease Characteristics

- No prior chemotherapy for this malignancy

- No prior temozolomide

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

- No prior radiotherapy to the brain, head, or neck

Surgery:

- At least 14 days since prior surgery requiring general anesthesia

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Michael A. Vogelbaum, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000069270

NCT ID:

NCT00033280

Start Date:

July 2002

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult anaplastic oligodendroglioma
  • adult mixed glioma
  • Nervous System Neoplasms
  • Oligodendroglioma
  • Central Nervous System Neoplasms

Name

Location

Akron City HospitalAkron, Ohio  44304
Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical CenterLa Crosse, Wisconsin  54601
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
Baptist Hospital of MiamiMiami, Florida  33176-2197
CCOP - ColumbusColumbus, Ohio  43206
Mercy Hospital of PittsburghPittsburgh, Pennsylvania  15219
Dixie Regional Medical CenterSaint George, Utah  84770
LDS HospitalSalt Lake City, Utah  84143
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
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 Utah Health Sciences CenterSalt Lake City, Utah  84132
Mobile Infirmary Medical CenterMobile, Alabama  36640-0460
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - OmahaOmaha, Nebraska  68114-4199
CCOP - Marshfield Clinic Research FoundationMarshfield, Wisconsin  54449
Adena Regional Medical CenterChillicothe, Ohio  54601
Mount Carmel West HospitalColumbus, Ohio  43222
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial HospitalMarietta, Ohio  45750
Cottonwood Hospital Medical CenterMurray, Utah  84107
McKay-Dee Hospital CenterOgden, Utah  84403
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Mayo ClinicJacksonville, Florida  32224
Shands Cancer Center at the University of Florida Health Science CenterGainesville, Florida  32610-0296
CCOP - Mayo Clinic Scottsdale Oncology ProgramScottsdale, Arizona  85259
University of Miami Sylvester Cancer CenterMiami, Florida  33136
Rutherford HospitalRutherfordton, North Carolina  28139
Wayne Memorial Hospital, Inc.Goldsboro, North Carolina  27533
Riverside Methodist HospitalColumbus, Ohio  43214
Licking Memorial HospitalNewark, Ohio  43055-2899
Anderson Area Cancer CenterAnderson, South Carolina  29621-5705