Halofuginone Hydrobromide in Treating Patients With Progressive Advanced Solid Tumors

European Organisation for Research and Treatment of Cancer - EORTC25 enrolled

Overview

RATIONALE: Halofuginone hydrobromide may stop the growth of solid tumors by stopping blood flow to the tumor. PURPOSE: Phase I trial to study the effectiveness of halofuginone hydrobromide in treating patients who have progressive advanced solid tumors.

OBJECTIVES: * Determine the toxicity profile, maximum tolerated dose, and dose-limiting toxic effects of halofuginone hydrobromide in patients with progressive advanced solid tumors. * Establish a recommended dose of this drug for phase II study. OUTLINE: This is a dose-escalation, multicenter study. Patients receive oral halofuginone hydrobromide once daily on days 1 and 4-14 of course 1 and on days 1-14 of subsequent courses. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity. Cohorts of 1-3 patients receive escalating doses of halofuginone hydrobromide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 20% of patients experience acute dose-limiting toxicity. After the MTD is reached, 6-12 additional patients are treated at dose levels preceding the MTD until the recommended dose for phase II study is determined. The recommended dose for phase II study is defined as the dose preceding the MTD that allows a 90% dose intensity for 2 months with no greater than grade 2 toxicity in 80% of the patients. Patients are followed every 8 weeks until disease progression or initiation of another treatment. PROJECTED ACCRUAL: Approximately 7-40 patients will be accrued for this study.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

halofuginone hydrobromideDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed advanced solid tumor that is not amenable to any clinical improvement by current standard treatments * No tumors of the upper digestive tract * No clinical signs of CNS involvement PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 OR * WHO 0-2 Life expectancy: * At least 12 weeks Hematopoietic: * WBC at least 3,000/mm\^3 * Neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10.0 g/dL Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST and ALT no greater than 2.5 times ULN * No unstable hepatobiliary disease that would preclude study Renal: * Creatinine no greater than 1.5 times ULN * No unstable renal disease that would preclude study Cardiovascular: * No unstable cardiovascular disease (e.g., stroke) that would preclude study Pulmonary: * No unstable pulmonary disease that would preclude study Gastrointestinal: * No digestive disease, including upper gastrointestinal tract, that would hamper absorption * No evident/known lactose malabsorption Other: * No allergy to components of the study drug * No uncontrolled infection * No other unstable systemic disease that would preclude study * No psychological, familial, sociological, or geographical condition that would preclude compliance * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior anticancer biologic therapy Chemotherapy: * At least 4 weeks since prior anticancer chemotherapy Endocrine therapy: * Prior anticancer hormonal therapy allowed Radiotherapy: * At least 6 weeks since prior radiotherapy * No concurrent radiotherapy Surgery: * At least 2 weeks since prior surgery Other: * At least 4 weeks since other prior anticancer treatment * No other concurrent anticancer agents or investigational therapy

Locations (3)

U.Z. Gasthuisberg

Leuven, Belgium

University Hospital - Rotterdam Dijkzigt

Rotterdam, Netherlands

Daniel Den Hoed Cancer Center at Erasmus Medical Center

Rotterdam, Netherlands

Data from ClinicalTrials.gov

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