NCT00003890

MG98 in Treating Patients With Advanced Solid Tumors

A Phase I Study of MG98 Given as a 2 Hour Twice Weekly IV Infusion in Patients With Advanced Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: NCIC Clinical Trials Group · Network
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	MG 98

Timeline

• Start date: 1999-02-22
• Primary completion: 2001-09-27
• Completion: 2008-09-22
• First posted: 2003-08-20
• Last updated: 2020-04-06

Locations

2 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study