Conditions: Sarcoma
Keywords: osteosarcoma soft tissue sarcoma rhabdomyosarcoma leiomyosarcoma Ewing's sarcoma chondrosarcoma liposarcoma malignant fibrous histiocytoma malignant peripheral nerve sheath tumor pleiomorphic sarcoma spindle cell sarcoma synovial sarcoma cancer stem cell
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 24
Healthy volunteers: no

Brief summary:
The purpose of this study is to identify a safe dosing regimen for the combination of Torisel and liposomal doxorubicin in patients with recurrent sarcoma. A secondary purpose of the study is to determine how effective this combination is for the treatment of recurrent sarcoma.

Detailed description:
The effectiveness of treatments for recurrent sarcomas is quite limited. One hypothesis to explain the refractory nature of recurrent sarcomas is the existence of chemotherapy-resistant sarcoma stem cells.

Arms:
arm 1: Single arm study: Dose escalation of temsirolimus plus constant dose of liposomal doxorubicin.

Interventions: intervention 1: temsirolimus plus liposomal doxorubicin
Intervention descriptions: intervention 1: Patients were treated with temsirolimus (Torisel) weekly by IV and with liposomal doxorubicin (Doxil) (standard dose) by IV once every 28 days. Cohorts of patients receive sequentially increasing dose of temsirolimus until dose limiting toxicity (DLT) occurred and the maximally tolerated dose (MTD) was identified. The MTD dose was the standard dose of temsirolimus used for the remainder of the study. Dose modifications were based on protocol parameters for toxicities.

Protocol document: