Brain and Central Nervous System Tumors Clinical Trial
Official title:
A Phase I/II Trial of EMD 121974 for Treatment of Patients With Recurrent Anaplastic Gliomas
RATIONALE: EMD 121974 may stop the growth of cancer by stopping blood flow to the tumor.
PURPOSE: Phase I/II trial to study the effectiveness of EMD 121974 in treating patients who
have progressive or recurrent malignant glioma.
OBJECTIVES:
- Determine the maximum tolerated dose and dose-limiting toxicity of EMD 121974 in
patients with progressive or recurrent malignant glioma.
- Determine the 6-month progression-free survival, clinical response rate, duration of
progression-free survival, and overall survival in patients treated with this drug.
- Determine the effects of this drug on tumor perfusion, measured with magnetic resonance
perfusion scan, and markers for angiogenesis in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive EMD 121974 IV over 1 hour twice weekly. Courses repeat every 4 weeks in the
absence of disease progression or unacceptable toxicity.
Cohorts of 6-12 patients receive escalating doses of EMD 121974 until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which more than 2
of 6 or 4 of 12 patients experience dose-limiting toxicity. Once the MTD is determined,
additional patients are treated at the MTD.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A minimum of 6 patients will be accrued for phase I of this study within
2-3 months. A total of 23-38 patients will be accrued for phase II of this study within 5-10
months.
;
Primary Purpose: Treatment
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