- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00027677
Halofuginone Hydrobromide in Treating Patients With Progressive Advanced Solid Tumors
Phase I Study To Determine The Safety Of Halofuginone In Patients With A Solid Progressive Tumor
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Leuven, Belgium, B-3000
- U.Z. Gasthuisberg
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Rotterdam, Netherlands, 3008 AE
- Daniel Den Hoed Cancer Center at Erasmus Medical Center
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Rotterdam, Netherlands, 3000 CA
- University Hospital - Rotterdam Dijkzigt
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Investigators
- Study Chair: Maja De Jonge, MD, PhD, Daniel Den Hoed Cancer Center at Erasmus Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Protein Synthesis Inhibitors
- Antiprotozoal Agents
- Antiparasitic Agents
- Coccidiostats
- Halofuginone
Other Study ID Numbers
- EORTC-16007
- COLLGARD-EORTC-16007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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