RATIONALE: Drugs used in chemotherapy, such as PR-104, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase I trial is studying the side effects and best dose of PR-104 in treating patients with advanced solid tumors.
OBJECTIVES: Primary * Evaluate the safety and tolerability of PR-104 in patients with advanced solid tumors. * Determine the maximum tolerated dose of PR-104 in these patients. Secondary * Characterize the pharmacokinetics of PR-104 and its alcohol metabolite in these patients. * Assess evidence of antitumor activity of this drug in these patients. Tertiary * Examine metabolic changes in tumors of these patients using fludeoxyglucose F 18 positron emission tomography scanning. OUTLINE: This is a multicenter, open-label, prospective, uncontrolled, dose-escalation study. Patients receive PR-104 IV over 60 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of PR-104 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. Blood is collected at baseline and then periodically during study treatment for pharmacokinetic and tumor marker studies. Patients undergo fludeoxyglucose F 18 positron emission tomography scanning before beginning study treatment and after completion of course 2 to assess metabolic activity of the tumor. After completion of study treatment, patients are followed at 30 days. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.