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A Trial of Everolimus and Bevacizumab in Children With Recurrent Solid Tumors

NCT00756340 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2015-10-14

No results posted yet for this study

Summary

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.

Conditions

  • Recurrent or Refractory Solid Tumors
  • CNS Malignancies

Interventions

DRUG

Bevacizumab

* 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

DRUG

Everolimus

* Everolimus * Dose Level 0- 4 mg/m2 * Dose level 1 (starting dose)- 4 mg/m2 * Dose Level 2- 5 mg/m2

Sponsors & Collaborators

Principal Investigators

  • Victor Santana, MD · St. Jude Children's Research Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00756340 on ClinicalTrials.gov