MG98 in Treating Patients With Advanced Solid Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of MG98 in treating patients who have advanced solid tumors.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Study of MG98 Given as a 2 Hour Twice Weekly IV Infusion in Patients With Advanced Cancer|
|Study Start Date:||February 1999|
|Study Completion Date:||September 2008|
- 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 patient population.
- 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 months.
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|Ottawa Regional Cancer Centre|
|Ottawa, Ontario, Canada, K1H 1C4|
|Study Chair:||Ross C. Donehower, MD||Sidney Kimmel Comprehensive Cancer Center|