Clinical trial · Interventional
Safety and Efficacy Study of Torisel and Liposomal Doxorubicin for Patients With Recurrent Sarcoma
Phase I/II Trial of Torisel and Liposomal Doxorubicin in Patients With Advanced Soft Tissue and Bone Sarcomas
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| temsirolimus plus liposomal doxorubicin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- temsirolimus plus liposomal doxorubicin
- description
- Single arm study: Dose escalation of temsirolimus plus constant dose of liposomal doxorubicin.
- interventionNames
- Drug: temsirolimus plus liposomal doxorubicin
Primary outcomes (2)
- measure
- Part 1: Incidence of Dose Limiting Toxicities
- timeFrame
- End of second 28-day cycle
- description
- Dose limiting toxicities in each dose cohort.
- measure
- Part 2: Median Overall Survival of Subjects Who Were Treated at the Temsirolimus MTD, 20 mg/m^2
- timeFrame
- up to 5 years
- description
- Number of days from day 1 of treatment until date of death from any cause.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed sarcoma that is recurrent or refractory to conventional treatment * Measurable disease by RECIST criteria * ECOG (Eastern Cooperative Oncology Group) performance status \< 2 (or Lansky/Karnofsky \> 60% for children) * Life expectancy greater than 3 months * Adequate organ function * absolute neutrophil count at least 1,500 * platelets at least 100,000 * bilirubin less than 1.5 x upper limit of normal * AST (aspartate aminotransferase) and ALT(alanine aminotransferase) less than 2.5 x upper limit of normal * creatinine less than 1.5 x upper limit of normal OR creatinine clearance at least 60 ml/min/1.73 m2 * fasting serum cholesterol less than 350 * fasting serum triglycerides less than 400 * PT (prothrombin) or INR (international normalized ratio) less than 1.3 x upper limit of normal * normal urinalysis * Ability to understand and sign the informed consent document Exclusion Criteria: * Prior chemotherapy or radiotherapy within 3 weeks of entering the study (6 weeks for nitrosoureas or mitomycin C) * Prior treatment with a tyrosine kinase inhibitor within 10 days of entering the study * History of pulmonary hypertension or pneumonitis * Patients may not be receiving other investigational agents * Prior therapy with rapamycin, rapamycin analogues, or tacrolimus * Uncontrolled brain metastases * History of grade 3 or 4 hypersensitivity to macrolide antibiotics * Concurrent treatment with immunosuppressive agents other than a stable (for more than 2 weeks) dose of corticosteroids * Uncontrolled intercurrent illness * Pregnancy or breast feeding * HIV-positive patients on combination antiretroviral therapy * Grade 3 or 4 proteinuria
References
Publications (2)
- RESULTThornton KA, Chen AR, Trucco MM, Shah P, Wilky BA, Gul N, Carrera-Haro MA, Ferreira MF, Shafique U, Powell JD, Meyer CF, Loeb DM. A dose-finding study of temsirolimus and liposomal doxorubicin for patients with recurrent and refractory bone and soft tissue sarcoma. Int J Cancer. 2013 Aug 15;133(4):997-1005. doi: 10.1002/ijc.28083. Epub 2013 Mar 4. PMID 23382028
- DERIVEDTrucco MM, Meyer CF, Thornton KA, Shah P, Chen AR, Wilky BA, Carrera-Haro MA, Boyer LC, Ferreira MF, Shafique U, Powell JD, Loeb DM. A phase II study of temsirolimus and liposomal doxorubicin for patients with recurrent and refractory bone and soft tissue sarcomas. Clin Sarcoma Res. 2018 Nov 5;8:21. doi: 10.1186/s13569-018-0107-9. eCollection 2018. PMID 30410720