MG98 in Treating Patients With Advanced Solid Tumors
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
- Registration Number
- NCT00003890
- Lead Sponsor
- NCIC Clinical Trials Group
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Ottawa Regional Cancer Centre
🇨🇦Ottawa, Ontario, Canada
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States