Halofuginone Hydrobromide in Treating Patients With Progressive Advanced Solid Tumors
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: halofuginone hydrobromide |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase I Study To Determine The Safety Of Halofuginone In Patients With A Solid Progressive Tumor |
| Enrollment: | 25 |
| Study Start Date: | August 2001 |
| Primary Completion Date: | February 2004 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Belgium | |
| U.Z. Gasthuisberg | |
| Leuven, Belgium, B-3000 | |
| Netherlands | |
| Daniel Den Hoed Cancer Center at Erasmus Medical Center | |
| Rotterdam, Netherlands, 3008 AE | |
| University Hospital - Rotterdam Dijkzigt | |
| Rotterdam, Netherlands, 3000 CA | |
| Study Chair: | Maja De Jonge, MD, PhD | Daniel Den Hoed Cancer Center at Erasmus Medical Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT00027677 History of Changes |
| Other Study ID Numbers: | EORTC-16007, EORTC-16007, COLLGARD-EORTC-16007 |
| Study First Received: | December 7, 2001 |
| Last Updated: | July 23, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
|
unspecified adult solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Neoplasms Halofuginone Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Coccidiostats Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents |
Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013