Safety and Efficacy Study of Torisel and Liposomal Doxorubicin for Patients With Recurrent Sarcoma
NCT00949325
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- 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
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | Safety and Efficacy Study of Torisel and Liposomal Doxorubicin for Patients With Recurrent Sarcoma | |||
Official Title ICMJE | Phase I/II Trial of Torisel and Liposomal Doxorubicin in Patients With Advanced Soft Tissue and Bone Sarcomas | |||
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. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 Phase 2 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Sarcoma | |||
Intervention ICMJE | Drug: temsirolimus plus liposomal doxorubicin
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. Other Names:
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Study Arms ICMJE | Experimental: temsirolimus plus liposomal doxorubicin
Single arm study: Dose escalation of temsirolimus plus constant dose of liposomal doxorubicin. Intervention: Drug: temsirolimus plus liposomal doxorubicin | |||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 24 | |||
Original Estimated Enrollment ICMJE | 45 | |||
Actual Study Completion Date ICMJE | September 2012 | |||
Actual Primary Completion Date | September 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 1 Year and older (Child, Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00949325 | |||
Other Study ID Numbers ICMJE | J0963 NA_00028490 ( Other Identifier: JHMI-IRB ) | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |||
Study Sponsor ICMJE | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |||
Verification Date | March 2019 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |