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Phase I/II Trial of Torisel and Liposomal Doxorubicin in Patients With Advanced Soft Tissue and Bone Sarcomas

Phase 1/Phase 2
1 Year
Not Enrolling

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Trial Information

Phase I/II Trial of Torisel and Liposomal Doxorubicin in Patients With Advanced Soft Tissue and Bone Sarcomas

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.

Inclusion Criteria:

- Histologically confirmed sarcoma that is recurrent or refractory to conventional

- Measurable disease by RECIST criteria

- ECOG 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 and ALT 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 or INR 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of dose limiting toxicities

Outcome Time Frame:

2 months

Safety Issue:


Principal Investigator

David M Loeb, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

September 2009

Completion Date:

September 2012

Related Keywords:

  • Sarcoma
  • 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
  • Sarcoma



Johns Hopkins University Baltimore, Maryland  21205