Completed
CC-8490 for Recurrent/Refractory High-Grade Gliomas
What is being tested
Data Collection
Who is being recruted
Astrocytoma+7
+ Glioblastoma
+ Glioma
Over 18 Years
+18 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1
Interventional
Study Start: December 2003
Summary
Principal SponsorCelgene Corporation
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: December 1, 2003
Actual date on which the first participant was enrolled.This study focuses on a drug called CC-8490, which is being tested as a potential treatment for high-grade gliomas, a type of brain tumor. These tumors are described as 'recurrent' or 'refractory', meaning they have either come back after previous treatment or have not responded well to standard treatments. The main goal of this research is to find out if CC-8490 can help people with these challenging types of brain tumors, aiming to improve their care and address the current lack of effective treatment options for this condition.
Official TitlePhase I Trial of CC-8490 for the Treatment of Subjects With Recurrent/Refractory High-Grade Gliomas
Principal SponsorCelgene Corporation
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
36 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
AstrocytomaGlioblastomaGliomaNeoplasmsNeoplasms by Histologic TypeNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeuroectodermal TumorsNeoplasms, Neuroepithelial
Criteria
13 inclusion criteria required to participate
Patients with glioblastoma multiforme (GBM), gliosarcoma, anaplastic astrocytoma (AA), anaplastic oligodendroglioma (AO), anaplastic mixed oligoastrocytoma (AMO), malignant glioma/astrocytoma NOS (not otherwise specified). Also included will be radiographically diagnosed infiltrating brain stem gliomas not amenable to biopsy. Other CNS tumor histologies will not be eligible for this trial.
Patients must have shown either evidence for tumor recurrence or progression by CT or (preferably) MRI scan performed within 21 days prior to registration or had biopsy proven recurrent glioma within the last 12 weeks prior to enrollment (in order to allow the enrollment of patients with recurrent gliomas who have undergone a complete radiographic resection and now have no radiographic evaluable disease)
Patients having undergone recent resection of a recurrent or progressive tumor will be eligible two weeks after surgery.
Patient must have failed prior radiation therapy and must have an interval of greater than or equal to 2 weeks from the completion of radiation therapy to study entry.
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5 exclusion criteria prevent from participating
Patients who, in the view of the treating physician, have significant active cardiac, hepatic, renal, or psychiatric diseases that would significantly increase the risk of using CC-8490 are ineligible.
Concurrent use of other standard chemotherapeutics or investigative agents.
Pregnant or lactating females.
Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study, obscures the evaluation of toxicity or alters drug metabolism.
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Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
Neuro Oncology BranchNational Cancer Institute
Bethesda, United StatesOpen Neuro Oncology BranchNational Cancer Institute in Google MapsCompletedOne Study Center