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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)
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


- 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

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


- Histologically or cytologically confirmed supratentorial pure or mixed anaplastic

- 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

- No spinal cord tumors

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



- 18 to 65

Performance status:

- Zubrod 0-1

Life expectancy:

- More than 12 weeks


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

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

- Hemoglobin at least 10 g/dL


- Bilirubin no greater than 2 times normal

- AST no greater than 3 times normal

- Alkaline phosphatase no greater than 2 times normal


- Creatinine no greater than 1.5 times normal


- 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


Biologic therapy:

- Not specified


- See Disease Characteristics

- No prior chemotherapy for this malignancy

- No prior temozolomide

Endocrine therapy:

- Not specified


- See Disease Characteristics

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


- At least 14 days since prior surgery requiring general anesthesia

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Michael A. Vogelbaum, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic


United States: Federal Government

Study ID:




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



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