Vorinostat and Bortezomib in Treating Patients With Metastatic or Unresectable Solid Tumors
Completed · Phase 1
Conditions studied: Unspecified Adult Solid Tumor, Protocol Specific
In brief
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 vorinostat, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vorinostat together with bortezomib may kill more tumor cells.
Key facts
- Study ID
- NCT00227513
- Run by
- National Cancer Institute (NCI)
- People needed
- 66
- Starts
- 2005-07-01
- Last updated by the study team
- 2014-02-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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