Vorinostat and Bortezomib in Treating Patients With Advanced Soft Tissue Sarcoma
Completed · Phase 2
Conditions studied: Recurrent Adult Soft Tissue Sarcoma, Stage III Adult Soft Tissue Sarcoma, Stage IV Adult Soft Tissue Sarcoma
In brief
This phase II trial is studying how well giving vorinostat together with bortezomib works in treating patients with advanced soft tissue sarcoma. Vorinostat and 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
- NCT00937495
- Run by
- National Cancer Institute (NCI)
- People needed
- 16
- Starts
- 2009-06-01
- Expected to finish
- 2011-06-01
- Last updated by the study team
- 2014-05-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically or cytologically confirmed advanced, unresectable, or metastatic soft tissue sarcoma (STS)
- Measurable disease, defined as >= 1 lesion that can be accurately measured in >= 1 dimension as >= 2 cm by conventional techniques OR >= 1 cm by spiral computed tomography (CT) scan
- No small round cell tumors, including the following:
- Primitive neuroectodermal tumor
- Rhabdomyosarcoma
- Ewing sarcoma
- Osteosarcoma
- No known active and/or untreated brain metastases and/or brain metastases requiring ongoing therapy (e.g., corticosteroids)
- Treated, inactive brain metastases not requiring ongoing therapy allowed provided the brain metastases have been stable for >= 1 month as assessed by intracranial imaging AND there is no indication of increased vascularity of the treated metastases within 14 days before study entry as assessed by magnetic resonance imaging (MRI)
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 OR Karnofsky PS 70-100%
- Life expectancy >= 12 weeks
- Absolute neutrophil count (ANC) >= 1,500/mm\^3
- Platelet count >= 100,000/mm\^3
- Total bilirubin normal
- Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) =< 2.5 times upper limit of normal
- Creatinine normal OR creatinine clearance >= 60 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Able to take oral medication
- No peripheral neuropathy >= grade 2
- No concurrent uncontrolled illness including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
Where it is running
- Mayo Clinic in Florida — Jacksonville, Florida, United States
- Johns Hopkins University — Baltimore, Maryland, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Metro-Minnesota CCOP — Saint Louis Park, Minnesota, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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