Protocol
CNS1022: A Phase II Randomized Trial of Lenalidomide (NSC#703813, IND#70116) in Pediatric Patients with Recurrent, Refractory or Progressive Juvenile Pilocytic Astrocytoma and Optic Pathway Gliomas
Diseases
Brain Tumor : Recurrent, refractory or progressive brain tumors
Description
This is a phase II randomized study to compare two doses of the study drug, lenalidomide, for the treatment of children with recurrent, refractory or progressive juvenile pilocytic astrocytoma (JPA) and optic pathway gliomas. Lenalidomide will be given by mouth for 3 weeks, followed by 1 week of rest. Treatment can continue for 26 cycles or 2 years, unless there is disease progression or unacceptable side effects. Correlative pharmacokinetic studies will be done.
Objectives
- To determine the response rate of children with recurrent, refractory or progressive juvenile astrocytomas and optic pathway gliomas who are treated with low-dose or high-dose of lenalidomide.
Eligibility
- Patients must be less than 22 years of age
- Patients must have a BSA> 0.4 m2 when entering the study
- Patients with primary recurrent, relapsed or refractory pilocytic astrocytoma or optic pathway glioma. Patients with neurofibromatosis (NF-1) are eligible.
- Adequate bone marrow and renal function
- Patients must be able to swallow capsules.
Contact
Ibrahim Qaddoumi, MD
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105 USA
Phone: 901-595-2544 or 901-595-4599
FAX: 901-595-5353
Or
Tabatha E. Doyle, RN
Coordinator, Brain Tumor Program
Phone: 901-595-2544
For the current eligibility status of this clinical study, patient’s family, relatives and/or referring physicians may contact St. Jude Children’s Research Hospital at (901) 595-4599 or (901) 595-2544.
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