This phase I trial studies the side effects and best dose of dasatinib and temsirolimus when
given together with cyclophosphamide in treating patients with solid tumors that have spread
to other places in the body, have come back, or have not respond to previous treatment.
Dasatinib and temsirolimus may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth. Drugs used in chemotherapy, such as cyclophosphamide, 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. Giving dasatinib and temsirolimus
together with cyclophosphamide may be a better treatment for advanced solid tumors.
I. To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of
combination treatment with dasatinib, cyclophosphamide and temsirolimus.
II. To define and describe the toxicities of the combination of dasatinib, cyclophosphamide
and temsirolimus administered on this schedule.
I. To preliminarily define the antitumor activity of the combination of dasatinib,
cyclophosphamide and temsirolimus within the confines of a phase 1 study.
II. Preliminary assessment of biological markers and correlates of response.
OUTLINE: This is a dose-escalation study of dasatinib and temsirolimus.
Patients receive dasatinib orally (PO) twice daily (BID) on days 1-21, cyclophosphamide PO
once daily (QD) on days 1-21, and temsirolimus intravenously (IV) over 30-60 minutes on days
1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease
progression or unacceptable toxicity. Patients experiencing stable disease or better may
continue treatment with the approval of the study chair.
After completion of study treatment, patients are followed up for 4 weeks.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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