A Phase II Randomized Trial of Lenalidomide in Pediatric Patients with Recurrent Refractory or Progressive Juvenile Pilocytic Astrocytomas and Optic Pathway Gliomas
Investigating Low-Dose vs High-Dose Treatment for Juvenile Brain Tumors
Brief description of study.
This randomized phase II trial studies how well low-dose lenalidomide works compared with high-dose lenalidomide in treating younger patients with juvenile pilocytic astrocytomas or optic nerve pathway gliomas that have come back (recurrent), have not responded to treatment (refractory), or are growing, spreading, or getting worse (progressive).
Detailed description of study
The purpose of this study is to determine the objective response rate in children with recurrent, refractory, or progressive juvenile pilocytic astrocytomas and optic pathway gliomas who are treated with Regimen A low-dose (20 mg/m^2/dose) or Regimen B high-dose (115 mg/m^2/dose) lenalidomide.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Gliomas
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Age: 21 years or below
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Gender: All
This study investigates how well low-dose versus high-dose investigational medication works in younger patients with certain brain tumors. These tumors include juvenile pilocytic astrocytomas and optic nerve pathway gliomas, which may have returned, not responded to treatment, or are worsening. The purpose of this study is to determine how effective the treatment is in managing these conditions.
Participants will be assigned to one of two study arms: Regimen A, which involves a low-dose treatment, or Regimen B, which involves a high-dose treatment. The study will compare the effectiveness of these two dosing regimens.
- Who can participate: Patients aged 18 years or younger with juvenile pilocytic astrocytomas or optic nerve pathway gliomas that are recurrent, refractory, or progressive may be eligible to participate.
- Study details: Participants will receive either a low-dose or high-dose of the investigational medication, depending on the study arm they are assigned to.
Interested in the study?
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