A Phase I Study of MG98 Given as a 2 Hour Twice Weekly IV Infusion in Patients With Advanced Cancer
- Determine the maximum tolerated dose of MG98 in patients with advanced solid tumors.
- Assess the safety, toxicity, and pharmacokinetics of this treatment regimen in this
- Evaluate the effectiveness of this treatment regimen in these patients.
OUTLINE: This is a dose escalation, multicenter study.
Patients receive MG98 IV over 2 hours twice weekly for 3 weeks. Courses are repeated every 4
weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
The dose of MG98 is escalated in cohorts of 1-6 patients until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6
patients experience dose limiting toxicity.
Patients are followed at week 4, then at least every 3 months until relapse of disease.
PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study within 10-12
Primary Purpose: Treatment
Ross C. Donehower, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|