Penclomedine in Treating Patients With Advanced Solid Tumors

Phase 1

Completed

• Conditions: Unspecified Adult Solid Tumor, Protocol Specific

• Registration Number: NCT00002915
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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 penclomedine in treating patients who have advanced solid tumors.

Detailed Description

OBJECTIVES: I. Determine the maximum tolerated dose of oral penclomedine that can be administered daily for 5 days every 4 weeks in patients with advanced solid tumor malignancies. II. Describe and quantitate the toxic effects of penclomedine administered on this schedule in these patients. III. Study the clinical pharmacology and metabolism of penclomedine on this schedule, and seek pharmacodynamic correlates of pharmacologic parameters with clinical endpoints. IV. Study the bioavailability of oral penclomedine, and qualitatively compare metabolite profiles produced following oral and intravenous administration in these patients. V. Seek preliminary evidence of therapeutic activity of penclomedine in patients with advanced cancer.

OUTLINE: This is a dose-escalation study to estimate the maximum tolerated dose (MTD) of penclomedine. Cohorts of 3-6 patients are treated at escalating doses until the MTD is reached. Patients receive oral penclomedine for 5 consecutive days every 4 weeks. If tumor progression or unacceptable toxicity is documented during any treatment course, the patient is removed from study. A total of 10 patients will be treated at the dose determined to be the MTD (the recommended phase II dose).

PROJECTED ACCRUAL: An estimated 20 patients will be accrued over approximately 10 months.

Study Timeline

• Study Start: 1996-12
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2004-06-15
• Study First Posted: 2004-06-16
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-05
• Last Update Posted: 2010-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Johns Hopkins Oncology Center; 🇺🇸 Baltimore, Maryland, United States