Vismodegib in Treating Patients With Advanced Chondrosarcomas (NCT01267955) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Vismodegib in Treating Patients With Advanced Chondrosarcomas
France45 participantsStarted 2010-12-21
Plain-language summary
This phase II trial studies how well vismodegib works in treating patients with chondrosarcomas that have spread to other places in the body and usually cannot be cured or controlled with treatment. Drugs used in chemotherapy, such as vismodegib, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients must have histologically confirmed diagnosis of chondrosarcoma (conventional, mesenchymal, dedifferentiated or clear cell subtypes)
* Patients must have measurable disease (outside any previously irradiated field) defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 10 mm with spiral computed tomography (CT) scan
* No more than three prior lines of chemotherapy for advanced disease (including no more than 450 mg/m\^2 doxorubicin); at least three weeks since last chemotherapy (six weeks in case of nitrosoureas and mitomycin C), immunotherapy or any other pharmacological treatment and/or radiotherapy
* Life expectancy of greater than 3 months
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
* Leukocytes \>= 3,000/mcL
* Absolute neutrophil count \>= 1,500/mcL
* Platelets \>= 100,000/mcL
* Total bilirubin within normal institutional limits
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 X institutional upper limit of normal
* Creatinine within normal institutional limits OR creatinine clearance \> 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
* Metastatic or unresectable locally advanced disease
* Documented disease progression (as per RECIST) before study entry
* Women of …
What they're measuring
1
Clinical Benefit Rate (CBR) Based on Centralized Imaging Review as Per RECIST 1.1