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A Phase I Trial of Hypofraction Radiotherapy + Temozolomide in the Treatment of Patients With Glioblastoma Multiforme and Anaplastic Astrocytoma of the Brain


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Glioblastoma Multiforme/Anaplastic Astrocytoma

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Trial Information

A Phase I Trial of Hypofraction Radiotherapy + Temozolomide in the Treatment of Patients With Glioblastoma Multiforme and Anaplastic Astrocytoma of the Brain


OBJECTIVES:

Primary

- To determine the maximum tolerated dose of temozolomide when given in combination with
hypofractionated intensity-modulated conformal stereotactic radiotherapy in patients
with newly diagnosed de novo glioblastoma multiforme or anaplastic astrocytoma.

Secondary

- To determine the time to neuroradiological evidence of tumor recurrence or progression
in patients treated with this regimen.

- To determine the survival time of patients treated with this regimen.

- To determine the time spent in a Karnofsky performance status of 60-100%.

OUTLINE: This is a dose-escalation study of temozolomide.

Beginning 1-3 weeks following surgery or biopsy, patients receive oral temozolomide once
daily for 5 weeks. Beginning 1 week after starting temozolomide, patients also undergo
hypofractionated intensity-modulated conformal stereotactic radiotherapy once daily 5 days a
week for 3 weeks.

After completion of study treatment, patients are followed at 1 month, 2 months, and 3
months, and then every 3 months thereafter.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed de novo glioblastoma multiforme or anaplastic astrocytoma
after biopsy or tumor removal

- Newly diagnosed disease

- No tumors located in the brainstem or optic chiasm

PATIENT CHARACTERISTICS:

- Karnofsky performance status 60-100%

- Hemoglobin ≥ 10 g/dL

- ANC ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Total bilirubin ≤ 1.5 mg/dL

- Creatinine ≤ 1.3 mg/dL

- AST/ALT ≤ 60 U/L

- BUN ≤ 24 mg/dL

PRIOR CONCURRENT THERAPY:

- No prior chemotherapy and/or radiotherapy for this cancer

- No prior radiotherapy to the brain

- At least 6 weeks since prior chemotherapy

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Maximum tolerated dose of temozolomide

Outcome Time Frame:

2009-present

Safety Issue:

Yes

Principal Investigator

Mario Ammirati, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

OSU-08119

NCT ID:

NCT00841555

Start Date:

February 2009

Completion Date:

Related Keywords:

  • Glioblastoma Multiforme/Anaplastic Astrocytoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • adult anaplastic astrocytoma
  • adult glioblastoma
  • GBM/AA
  • Astrocytoma
  • Glioblastoma

Name

Location
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center Columbus, Ohio  43210-1240