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Sponsored by: |
St. Jude Children's Research Hospital |
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Information provided by: | St. Jude Children's Research Hospital |
ClinicalTrials.gov Identifier: | NCT00756340 |
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.
Condition | Intervention | Phase |
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Recurrent or Refractory Solid Tumors CNS Malignancies |
Drug: Bevacizumab Drug: Everolimus |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase I Trial of RAD001 (Everolimus) and Avastin in Children With Recurrent Solid Tumors |
Estimated Enrollment: | 24 |
Study Start Date: | July 2008 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
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Drug: Bevacizumab
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This is a traditional phase I dose finding study to estimate the maximum tolerated dose (MTD) and describe the dose limiting toxicities (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. Patients will receive bevacizumab every two weeks IV, and everolimus orally daily. Four consecutive weeks will constitute one course and subsequent courses will immediately follow with no break in the administration of either drug. In the absence of disease progression or unacceptable toxicity, treatment can continue for 2 years. The bevacizumab dose will start at 10 mg/kg. Everolimus will start at 4 mg/m2, 80% of the MTD established in our current phase I trial. A traditional 3+3 dose escalation/de-escalation design will be used to determine the joint MTD for these two agents. Doses to be studied are detailed in the table below. Consistent with the traditional design, we will enroll cohorts of 3 patients at each dose level starting with dose level 1 and will escalate to the next higher dose, if none of these 3 experiences a DLT. If one of 3 patients experiences a DLT at a dose level then 3 more patients will be studied at this level. If none of these 3 experiences a DLT then escalation to the next level will occur.
Otherwise the current dose will be considered too toxic and de-escalation will occur. Under this setting, MTD will be the dose level at which 0/3 or 1/6 patient would have experienced DLT and the next dose level is determined to be too toxic.
Additional objectives include:
Ages Eligible for Study: | up to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Use of H2 antagonists such as ranitidine, cimetidine and proton pump blockers such as omeprazole are permissible only in conjunction with corticosteroids in the setting of increased intracranial pressure or for spinal cord compression, as these drugs interfere with CYP3A4. If patients are given such drugs, they must be taken at least 4 hours after intake of everolimus.
Exclusion Criteria:
Use of H2 antagonists such as ranitidine, cimetidine and proton pump blockers such as omeprazole are permissible only in conjunction with corticosteroids in the setting of increased intracranial pressure or for spinal cord compression, as these drugs interfere with CYP3A4. If patients are given such drugs, they must be taken at least 4 hours after intake of everolimus.
Contact: Lisa McGregor, MD, PhD | 1-866-278-5833 | info@stjude.org |
United States, Tennessee | |
St. Jude Children's Research Hospital | Recruiting |
Memphis, Tennessee, United States, 38105 | |
Contact: Lisa McGregor, MD, PhD 866-278-5833 info@stjude.org | |
Principal Investigator: Lisa McGregor, MD, PhD |
Principal Investigator: | Lisa McGregor, MD, PhD | St. Jude Children's Research Hospital |
Responsible Party: | St. Jude Children's Research Hospital ( Lisa McGregor, MD, PhD ) |
Study ID Numbers: | RADBEV |
Study First Received: | September 18, 2008 |
Last Updated: | March 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00756340 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Everolimus Immunologic Factors Bevacizumab Central Nervous System Neoplasms |
Angiogenesis Inhibitors Immunosuppressive Agents Nervous System Neoplasms Recurrence |
Everolimus Disease Attributes Immunologic Factors Antineoplastic Agents Growth Substances Nervous System Diseases Physiological Effects of Drugs Central Nervous System Neoplasms Bevacizumab Angiogenesis Inhibitors |
Immunosuppressive Agents Pharmacologic Actions Recurrence Neoplasms Pathologic Processes Neoplasms by Site Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Nervous System Neoplasms |