Safety and Efficacy Study of Torisel and Liposomal Doxorubicin for Patients With Recurrent Sarcoma

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborators: National Comprehensive Cancer Network; Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Doxorubicin; Everolimus; Liposomal doxorubicin; Sirolimus

Criteria

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