Carbendazim in Treating Patients With Advanced Solid Tumors or Lymphoma
|ClinicalTrials.gov Identifier: NCT00023816|
Recruitment Status : Unknown
Verified December 2001 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : April 5, 2004
Last Update Posted : September 20, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma Unspecified Adult Solid Tumor, Protocol Specific||Drug: carbendazim||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Third Phase I and Pharmacokinetic Study Of FB-642 Administered Orally To Patients With Advanced Solid Tumors|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00023816
|Study Chair:||Lee S. Rosen, MD||Jonsson Comprehensive Cancer Center|