Lenalidomide and Radiation Therapy in High Grade Gliomas or Diffuse Intrinsic Pontine Gliomas
Status:
Completed
Trial end date:
2019-04-17
Target enrollment:
Participant gender:
Summary
Background:
- Children who are diagnosed with brain tumors known as high grade gliomas or diffuse
intrinsic pontine gliomas are generally treated with radiation therapy and chemotherapy.
However, these tumors are very difficult to cure, and the tumor frequently begins to grow
again even after treatment or surgery. Researchers are interested in determining whether the
anticancer drug lenalidomide, which has been used to treat other aggressive types of cancer,
is a safe and effective additional treatment for children who are scheduled to receive
radiation therapy to treat high grade gliomas or diffuse intrinsic pontine gliomas.
Objectives:
- To determine the safety and effectiveness of lenalidomide, in conjunction with radiation
therapy, as a treatment for children who have been diagnosed with high grade gliomas or
diffuse intrinsic pontine gliomas.
Eligibility:
- Children and adolescents up to 21 years of age who have been diagnosed with high grade
gliomas or diffuse intrinsic pontine gliomas and have not had radiotherapy or chemotherapy.
Design:
- Participants will be screened with a medical history, physical examination, blood and
urine tests, and imaging studies.
- Participants will have two phases of treatment: a lenalidomide plus radiation phase and
a lenalidomide-only phase.
- During the radiation phase, participants will take lenalidomide daily and have 6 weeks
of radiation therapy (five treatments per week). After the radiation therapy,
participants will stop taking lenalidomide for 2 weeks before continuing to the next
phase.
- During the lenalidomide-only phase, participants will take lenalidomide daily for 21
days, followed by 7 days without lenalidomide (28-day cycle of treatment). Participants
will have up to 24 cycles of lenalidomide.
- Participants will have frequent blood tests during the first cycle of treatment, and
will have imaging studies or other tests as required by the study researchers.
- Treatment will continue until the disease progresses, the participant chooses to leave
the study, or the researchers end the study.