NCT02389309

Dasatinib, Temsirolimus, and Cyclophosphamide in Treating Patients With Advanced, Recurrent, or Refractory Solid Tumors

A Phase I Trial of Dasatinib (PDGFR and SRC Inhibitor), Temsirolimus, and Cyclophosphamide in Patients With Advanced Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 12 Months – 20 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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 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.

Conditions

• Advanced Malignant Solid Neoplasm
• Recurrent Brain Neoplasm
• Recurrent Malignant Solid Neoplasm
• Refractory Brain Neoplasm

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	Given PO
DRUG	Dasatinib	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Temsirolimus	Given IV

Timeline

• Start date: 2015-10-05
• Primary completion: 2027-10-31
• Completion: 2027-10-31
• First posted: 2015-03-17
• Last updated: 2026-03-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study