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Carbendazim in Treating Patients With Advanced Solid Tumors or Lymphoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2001 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00023816
First received: September 13, 2001
Last updated: September 19, 2013
Last verified: December 2001

September 13, 2001
September 19, 2013
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Complete list of historical versions of study NCT00023816 on ClinicalTrials.gov Archive Site
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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

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.

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.

Interventional
Phase 1
Primary Purpose: Treatment
  • Lymphoma
  • Unspecified Adult Solid Tumor, Protocol Specific
Drug: carbendazim
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
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DISEASE CHARACTERISTICS: Histologically confirmed advanced solid tumor for which no standard therapy exists or which has progressed or recurred after prior therapy OR Lymphoma for which no further therapeutic options exist No hematological malignancies (e.g., leukemia) No known brain or leptomeningeal disease unless previously treated with radiotherapy, not currently treated with corticosteroid therapy, and no clinical symptoms present

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Hemoglobin at least 9 g/dL Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 mg/dL AST or ALT no greater than 3 times upper limit of normal (ULN) (5 times ULN if due to tumor involvement) Alkaline phosphatase less than 2.5 times ULN Renal: Creatinine no greater than 2 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No unstable atrial or ventricular arrhythmias that require control by medication No ischemic event within the past 6 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Abnormalities that would affect absorption of study drug allowed at investigator's discretion No other severe disease or psychiatric disorder that would preclude study No phenylketonuria No known hypersensitivity reaction to artificial sweetener aspartame (e.g., Nutrasweet)

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Recovered from prior chemotherapy for cancer No other concurrent cytotoxic therapy Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics Recovered from prior radiotherapy for cancer Surgery: Recovered from prior surgery for cancer Prior gastrointestinal surgery allowed

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00023816
CDR0000068867, UCLA-0002007, ILEX-FB-642-103-A4, NCI-G01-2006
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Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Lee S. Rosen, MD Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
December 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP