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.
PRIMARY OBJECTIVES: I. To determine the objective response rate in patients with advanced soft tissue sarcoma treated with vorinostat and bortezomib. SECONDARY OBJECTIVES: I. Characterize the toxicity of this regimen in these patients. II. Evaluate the progression-free survival and median overall survival of patients treated with this regimen. OUTLINE: Patients receive vorinostat orally (PO) once daily on days 1-14. Patients also receive bortezomib intravenously (IV) over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed up every 6 months for up to 2 years. (As of Addendum 7, patient follow-up no longer required.)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
400 mg given PO
1.3 mg/m\^2 given IV
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
Confirmed Tumor Responses
The number of confirmed tumor responses is defined as a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) on two consecutive evaluations at least six weeks apart. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest dimension (LD) of target lesions taking as reference the baseline sum LD.
Time frame: Up to 2 years
Progression Free Survival
Progression-free survival is defined as the time from registration to the time of progression or death, whichever comes first. The distribution and median of progression-free survival times will be estimated using the method of Kaplan-Meier.
Time frame: Up to 2 years
Overall Survival
The distribution of survival time will be estimated using the method of Kaplan-Meier.
Time frame: Time from registration to death due to any cause, assessed up to 2 years
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Washington University School of Medicine
St Louis, Missouri, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States