PR-104 in Treating Patients With Advanced Solid Tumors
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
- Interventions
- Registration Number
- NCT00349167
- Lead Sponsor
- Proacta, Incorporated
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PR-104 laboratory biomarker analysis PR104 was administered as a 1-hr IV infusion every 21 days at doses ranging from 135 to 1400 mg/m2 PR-104 pharmacological study PR104 was administered as a 1-hr IV infusion every 21 days at doses ranging from 135 to 1400 mg/m2 PR-104 PR-104 PR104 was administered as a 1-hr IV infusion every 21 days at doses ranging from 135 to 1400 mg/m2
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Jonsson Comprehensive Cancer Center at UCLA
🇺🇸Los Angeles, California, United States