Recurrent Adult Soft Tissue Sarcoma Clinical Trial
Official title:
A Phase II Study of Suberoylanilide Hydroxamic Acid and Bortezomib in Advanced Soft Tissue Sarcomas
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.
Status | Completed |
Enrollment | 16 |
Est. completion date | June 2011 |
Est. primary completion date | August 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 - Cardiac arrhythmia or myocardial infarction within the past 6 months - Psychiatric illness and/or social situation that would limit compliance with study requirements - No history of Torsades de Pointes - No history of allergic reactions attributed to compounds of similar chemical or biological composition to vorinostat or bortezomib - No more than 1 prior systemic treatment for advanced STS, including investigational agents - Adjuvant therapy is not considered a systemic regimen - More than 2 weeks since prior valproic acid - More than 4 weeks since prior and no concurrent chemotherapy (> 6 weeks for nitrosoureas or mitomycin C) or radiotherapy and recovered - Radiotherapy to bone metastasis within the past 2 weeks allowed provided there is active non-bone disease outside the radiation port - No prior radiotherapy to >= 33% of the bone marrow - No prior vorinostat or bortezomib - No concurrent category I medications that are generally accepted to have a risk of causing Torsades de Pointes, including any of the following: - Quinidine, procainamide, disopyramide - Amiodarone, sotalol, ibutilide, dofetilide - Erythromycin, clarithromycin - Chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine - No concurrent combination antiretroviral therapy for human immunodeficiency virus (HIV)-positive patients - No other concurrent investigational agents for the primary malignancy - No other concurrent anticancer therapy |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins University | Baltimore | Maryland |
United States | Mayo Clinic in Florida | Jacksonville | Florida |
United States | University of Wisconsin Hospital and Clinics | Madison | Wisconsin |
United States | Mayo Clinic | Rochester | Minnesota |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | Metro-Minnesota CCOP | Saint Louis Park | Minnesota |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
Up to 2 years | No |
Secondary | 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. | Up to 2 years | No |
Secondary | Overall Survival | The distribution of survival time will be estimated using the method of Kaplan-Meier. | Time from registration to death due to any cause, assessed up to 2 years | No |
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