Halofuginone Hydrobromide in Treating Patients With Progressive Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00027677
First received: December 7, 2001
Last updated: July 23, 2012
Last verified: July 2012
  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

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Enrollment: 25
Study Start Date: August 2001
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00027677

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
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

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 August 27, 2014