Halofuginone Hydrobromide in Treating Patients With Progressive Advanced Solid Tumors

• ClinicalTrials.gov Identifier: NCT00027677
• Recruitment Status: Completed
• First Posted: January 27, 2003
• Last Update Posted: July 24, 2012
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Information provided by (Responsible Party): European Organisation for Research and Treatment of Cancer - EORTC

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Unspecified Adult Solid Tumor, Protocol Specific	Drug: halofuginone hydrobromide	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 25 participants
• Primary Purpose: Treatment
• Official Title: Phase I Study To Determine The Safety Of Halofuginone In Patients With A Solid Progressive Tumor
• Study Start Date: August 2001
• Actual Primary Completion Date: February 2004

Arms and Interventions

Outcome Measures

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Locations

Belgium

U.Z. Gasthuisberg

Leuven, Belgium, B-3000

Netherlands

University Hospital - Rotterdam Dijkzigt

Rotterdam, Netherlands, 3000 CA

Daniel Den Hoed Cancer Center at Erasmus Medical Center

Rotterdam, Netherlands, 3008 AE

Sponsors and Collaborators

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

• Study Chair: Maja De Jonge, MD, PhD; Daniel Den Hoed Cancer Center at Erasmus Medical Center

More Information

• Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
• ClinicalTrials.gov Identifier: NCT00027677
• Other Study ID Numbers: EORTC-16007; EORTC-16007; COLLGARD-EORTC-16007
• First Posted: January 27, 2003
• Last Update Posted: July 24, 2012
• Last Verified: July 2012

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:

unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:

Halofuginone; Neoplasms; Antineoplastic Agents; 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