A Trial of Everolimus and Bevacizumab in Children With Recurrent Solid Tumors
Part of paid clinical trials in Memphis, Tennessee.
- Sponsor
- St. Jude Children's Research Hospital
- Study ID
- NCT00756340
- Phase
- PHASE1
- Status
- Completed
Conditions
- CNS Malignancies
- Recurrent or Refractory Solid Tumors
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - 21 Years
- Healthy Volunteers
- Not accepted
Interventions
- Bevacizumab — DRUG* Bevacizumab IV every 2 weeks * Dose Level 0- 8 mg/kg * Dose Level 1 (starting dose)- 10 mg/kg * Dose Level 2- 10 mg/kg
- Everolimus — DRUG* Everolimus * Dose Level 0- 4 mg/m2 * Dose level 1 (starting dose)- 4 mg/m2 * Dose Level 2- 5 mg/m2
Study Details
The main goals of this Phase I study are to learn about the side effects that may occur when everolimus and bevacizumab are given to children and young adults and to find the highest doses of these drugs that can be given together without causing severe side effects. Bevacizumab will be given into the vein (IV) over 30-90 minutes every two weeks and everolimus tablets will be given daily by mouth. A cycle of therapy will be four weeks.
Key Dates
- First listed
- Sep 22, 2008
- Start date
- Jul 31, 2008
- Status verified
- Oct 2015
- Primary completion
- Sep 30, 2015
- Completion
- Sep 30, 2015
Study Design
- Enrollment
- 16 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: 1* Dose Level 0, Bevacizumab IV every 2 weeks 8 mg/kg, Everolimus 4 mg/m\^2 * Dose Level 1 (starting dose), Bevacizumab IV every 2 weeks 10 mg/kg, Everolimus 4 mg/m\^2 * Dose Level 2, Bevacizumab IV every 2 weeks 10 mg/kg, Everolimus 5 mg/m\^2
Primary Outcome Measure
To estimate the MTD and describe the DLT of the combination of bevacizumab, administered every 2 weeks IV and everolimus administered orally daily to children with recurrent or refractory solid tumors including CNS malignancies [ Time Frame: Within 30 days per subject ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | - |
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