Status:
COMPLETED
Vorinostat and Doxorubicin in Treating Patients With Metastatic or Locally Advanced Solid Tumors
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial is studying the side effects and best dose of vorinostat when given together with doxorubicin in treating patients with metastatic or locally advanced solid tumors. Vorinostat may s...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the safety and tolerability of vorinostat (SAHA) and doxorubicin hydrochloride in patients with metastatic or locally advanced solid tumors. II. Determine the maximu...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically or cytologically confirmed solid tumor malignancies for which no curative therapy exists
- Measurable or evaluable disease with tumor that is accessible to biopsy as determined by CT scan or ultrasound
- Skin, lymph nodes, or chest wall lesions are allowed provided measurements are confirmed by 2 independent health care professionals
- No uncontrolled CNS metastases
- Patients with stable CNS metastases (either surgically resected, treated with gamma knife, or stable for 3 months after whole-brain radiotherapy and documented by MRI within the past 4 weeks) are eligible
- Willing to undergo pre- and post-vorinostat tumor biopsies
- Life expectancy ≥ 3 months
- ECOG performance status 0-2
- WBC \> 3,000/mm\^3
- Absolute neutrophil count \> 1,500/mm\^3
- Hemoglobin \> 9.0 g/dL
- Platelet count \> 100,000/mm\^3 (transfusion independent)
- Creatinine ≤ 2.0 mg/mL
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 1.5 times ULN
- LVEF \> 50%
- Fertile patients must use effective contraception during and for 6 months after completion of study treatment
- Negative pregnancy test
- Not pregnant or nursing
- No significant active infection (e.g., pneumonia, cellulitis, or wound abscess)
- No history of cardiac failure
- No history of long QT syndrome (QTc \> 470 msec)
- No history of ventricular tachycardia or fibrillation
- No history of seizures
- No history of allergic reactions attributed to compounds of similar chemical or biological composition to vorinostat or other agents used in the study
- More than 3 weeks since prior chemotherapy or radiotherapy (2 weeks for weekly regimens)
- More than 2 weeks since prior valproic acid or any other histone deacetylase inhibitors
- No prior anthracycline exposure
- No other concurrent chemotherapy
- No concurrent hormonal therapy except for maintenance therapy with luteinizing-hormone releasing-hormone agonists
- No concurrent antiarrhythmics
- No concurrent steroids to control brain metastasis
- No concurrent colony-stimulating factors (e.g., filgrastim \[G-CSF\] or sargramostim \[GM-CSF\]) during the first course of study treatment
- No other concurrent investigational agents for primary disease
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00331955
Start Date
March 1 2006
Last Update
July 2 2013
Active Locations (1)
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1
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612