Patient Abstract available in the near future.

Condition	Treatment or Intervention	Phase
Leukemia Lymphoma Eye Cancer	Drug: carbendazim	Phase I

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--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

--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

--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)

Study chairs or principal investigators

Lee S. Rosen,  Study Chair,  Jonsson Comprehensive Cancer Center   

Study ID Numbers:  CDR0000068867; UCLA-0002007; NCI-G01-2006; ILEX-FB-642-103-A4
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  September 13, 2001
ClinicalTrials.gov Identifier:  NCT00023816
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08