Halofuginone Hydrobromide in Treating Patients With Progressive Advanced Solid Tumors

NCT00027677 | Completed Phase 1

• 2 other identifiers: EORTC-16007COLLGARD-EORTC-16007
• Study Type: interventional
• Target: 25
• Locations: 2 countries
• Sites: 3

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

halofuginone hydrobromide DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (3)

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

University Hospital - Rotterdam Dijkzigt

Rotterdam, 3000 CA, Netherlands

Location

Daniel Den Hoed Cancer Center at Erasmus Medical Center

Rotterdam, 3008 AE, Netherlands

Location

MeSH Terms

Interventions

halofuginone

Study Officials

• Maja De Jonge, MD, PhD

  Daniel Den Hoed Cancer Center at Erasmus Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2001
• First Posted: January 27, 2003
• Study Start: August 1, 2001
• Primary Completion: February 1, 2004
• Last Updated: July 24, 2012

Record last verified: 2012-07

Locations

BE (1); NL (2)