Chondrosarcomas Clinical Trial
Official title:
Sarcoma Alliance for Research Through Collaboration (SARC) Multicenter Trial: A Phase II Trial of Perifosine in Patients With Chemo-Insensitive Sarcomas
This is a phase II study of perifosine in patients with chondrosarcomas, alveolar soft part
sarcomas and extra-skeletal myxoid chondrosarcomas. Patients will receive perifosine 100 mg
orally qhs with food until disease progression. The goals of this study include:
- In this study a daily dose of perifosine previously determined to be relatively
non-toxic will be evaluated in patients with chondrosarcomas, alveolar soft part
sarcomas and extra-skeletal myxoid chondrosarcomas.
- Response to therapy will be based on regression of measurable disease according to Choi
criteria. Time to progression and duration of stable disease will be measured as
secondary endpoints of the study.
This is a phase II study of perifosine in patients with chondrosarcomas, alveolar soft part
sarcomas and extra-skeletal myxoid chondrosarcomas. Patients will receive perifosine 100 mg
orally qhs with food until disease progression.
Perifosine is available in 50 mg tablets. Patients will take two perifosine 50 mg tablets
orally once a day at bedtime with food. Administering the drug qhs has been shown to decrease
gastrointestinal toxicity in some patients. Patients may need anti-emetics and/or
anti-diarrheals. All patients may continue therapy unless disease progression is documented
on two occasions at least 4 weeks apart. Patients who experience toxicity may continue on
treatment with doses delayed or reduced. Evaluation of all lesions for progression or
response will be made at 3-month intervals.
STUDY KEY POINTS
- Treatment will be administered on an outpatient basis in 28-day cycles.
- Growth factors should not be needed, however, use by patients on this trial is NOT
prohibited.
- A favorable outcome will be defined as a complete or partial response according to the
Choi criteria or stable disease by the Choi criteria for 6 months or longer.
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