NCT00023816

Carbendazim in Treating Patients With Advanced Solid Tumors or Lymphoma

Third Phase I and Pharmacokinetic Study Of FB-642 Administered Orally To Patients With Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of carbendazim in treating patients who have advanced solid tumors or lymphoma.

Detailed description

OBJECTIVES: I. Determine the maximum tolerated dose of carbendazim in patients with advanced solid tumors or lymphoma. II. Determine the qualitative and quantitative toxic effects of this drug in these patients. III. Determine the pharmacokinetics of this drug in these patients. IV. Determine the recommended phase II dose of this drug. V. Determine any antitumor effects of this drug in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients receive oral carbendazim 2-3 times daily 5 days a week for 3-4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of carbendazim until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 30 days. PROJECTED ACCRUAL: Approximately 30-60 patients will be accrued for this study.

Conditions

• Lymphoma
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	carbendazim

Timeline

• First posted: 2004-04-05
• Last updated: 2013-09-20