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Research and Clinical Trials

Brief Description  
The primary goals of this randomized Phase II study are to determine the feasibility of administering bevacizumab or temsirolimus with a chemotherapy regimen of intravenous vinorelbine and cyclophosphamide (VC), and to compare the event-free survival (EFS) between patients with recurrent/refractory rhabdomyosarcoma (RMS) treated with VC + bevacizumab and those treated with VC + temsirolimus. The study results will provide background data to support the feasibility of the addition of bevacizumab
Who may be Eligible  

Inclusion Criteria:
General Inclusion Criteria:
  1. Age <30 years at time of study enrollment
  2. Patients must be enrolled within six weeks from the diagnosis of first relapse, disease progression, or primary refractory disease
  3. Patients must have recovered from any surgical procedure prior to study enrollment
  4. Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy
  5. Adequate organ function as demonstrated by laboratory evaluation

Exclusion Criteria:
  1. Patients with botryoid histology
  2. Patients with embryonal histology, Stage I or Clinical Group I at initial presentation, who present with local or regional recurrence
  3. Patients who have previously received vinorelbine, bevacizumab, temsirolimus
  4. Patients with known, untreated central nervous system (CNS) disease
  5. Patient who are pregnant or are breastfeeding
  6. Patients with a documented chronic non-healing wound, ulcer, or significant trauma injury within 28 days
  7. Patients with evidence of intratumoral hemorrhage, gastrointestinal bleeding, or on anticoagulation for thrombosis or history of thrombosis
  8. Patients with uncontrolled hypertension
  9. Patients currently taking anticoagulants or antiplatelet agents other than aspirin (=81 mg/day)
  10. Patients with clinically significant cardiovascular disease
Speciality/Disorder  
Relapsed/Refractory Rhabdomyosarcoma
IRB Number  
01-11-05A
Principal Investigator  
Kaplan, Joel

For More Information, Contact  Julie  A, Chasnis
Phone:  (704) 446-5154  Fax:  (704) 355-1188  
Email:  julie.chasnis@carolinashealthcare.org
Address:1025 Morehead Medical Plaza Suite 600 Charlotte, NC 28204
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