Dasatinib, Temsirolimus, and Cyclophosphamide in Treating Patients With Advanced, Recurrent, or Refractory Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Advanced Malignant Solid Neoplasm
- Recurrent Brain Neoplasm
- Recurrent Malignant Solid Neoplasm
- Refractory Brain Neoplasm
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 1220 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: 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 administere...
PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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.
Tracking Information
- NCT #
- NCT02389309
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Wafik T Zaky M.D. Anderson Cancer Center