Status:
COMPLETED
Vorinostat and Bortezomib in Treating Patients With Metastatic or Unresectable 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 and bortezomib in treating patients with metastatic or unresectable solid tumors. Drugs used in chemotherapy, such as vorino...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose of vorinostat (SAHA) and bortezomib in patients with metastatic or unresectable solid tumors. SECONDARY OBJECTIVES: I. Determine the phar...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically confirmed malignancy, metastatic or unresectable disease
- Standard curative or palliative measures do not exist OR are no longer effective
- Measurable or evaluable disease
- No known brain metastases
- ECOG 0-2 OR Karnofsky 60-100%
- Life expectancy \> 12 weeks
- WBC ≥ 3,000/mm\^3
- Absolute neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Bilirubin normal
- AST and ALT ≤ 2.5 times upper limit of normal
- Creatinine normal OR creatinine clearance ≥ 60 mL/min
- No history of myocardial infarction
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- No severe pulmonary disease requiring oxygen
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 28 days after study participation
- No history of allergic reaction attributed to compounds of similar chemical or biological composition to study drugs or agents
- No pre-existing neuropathy ≥ grade 2
- No uncontrolled illness
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study compliance
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- No prior radiotherapy to \> 25% of bone marrow
- At least 4 weeks since prior radiotherapy and recovered
- At least 2 weeks since prior valproic acid
- No prior bortezomib
- No concurrent enzyme-inducing anticonvulsant agents
- No other concurrent investigational agents
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent anticancer therapy
Exclusion
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00227513
Start Date
July 1 2005
Last Update
February 24 2014
Active Locations (1)
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1
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792