Phase I Study To Determine The Safety Of Halofuginone In Patients With A Solid Progressive Tumor
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Phase I Study To Determine The Safety Of Halofuginone In Patients With A Solid Progressive Tumor
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Maja De Jonge, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Authority:
United States: Federal Government
Study ID:
EORTC-16007
NCT ID:
NCT00027677
Start Date:
August 2001
Completion Date:
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
- Neoplasms
Name | Location |
|---|
