Halofuginone Hydrobromide in Treating Patients With Progressive Advanced Solid Tumors

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase I Study To Determine The Safety Of Halofuginone In Patients With A Solid Progressive Tumor

Conditions
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Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Drug: halofuginone hydrobromide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: halofuginone hydrobromide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unspecified adult solid tumor, protocol specific