Completed

Phase I Trial of CC-8490 for the Treatment of Subjects With Recurrent/Refractory High-Grade Gliomas

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Data Collection

Who is being recruted

Astrocytoma
+7

+ Glioblastoma
+ Glioma
Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: December 2003
See protocol details

Summary

Principal SponsorCelgene Corporation
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: December 1, 2003Actual date on which the first participant was enrolled.

Phase I trial of CC-8490 for the treatment of subjects with recurrent/refractory high-grade gliomas

Official TitlePhase I Trial of CC-8490 for the Treatment of Subjects With Recurrent/Refractory High-Grade Gliomas 
NCT00074646
Principal SponsorCelgene Corporation
Last updated: January 13, 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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Astrocytoma
Glioblastoma
Glioma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neoplasms, Neuroepithelial
Criteria

Inclusion Criteria: * 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. * All patients must sign an informed consent, or if cognitively impaired, their assigned DPA, indicating that they are aware of the investigational nature of this study. * Patients must be \> 18 years old, and must have a life expectancy \> 8 weeks. * Patients must have a Karnofsky performance status of \> 60. * Additionally, patients must be at least 6 weeks from nitrosoureas, 4 weeks from temozolomide or carboplatin, 3 weeks from procarbazine, and 2 weeks from last vincristine administration. Patients must be at least 4 weeks from other cytotoxic therapies not listed above and 2 weeks for non-cytotoxic agents (e.g., interferon, tamoxifen). * Patients must have adequate bone marrow function (granulocyte count \>= 1500/mm3, platelet count of \> 100,000/mm3, and hemoglobin \> 8 gm%), adequate liver function (total bilirubin \<= 1.5 mg/dL, AST/ALT \<= 2 x ULN), and adequate renal function (creatinine \<= 1.5 mg/dL or creatinine clearance \> 60 cc/min) before starting therapy. These tests must be performed within 14 days prior to registration. Eligibility level for hemoglobin may be reached by transfusion. Eligibility level for platelets may not be reached by transfusion. * Patients must either not be receiving steroids, or be on a stable dose of steroids for at least five days prior to registration. * Patients with a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix) are ineligible, unless they are in complete remission and off all therapy for that disease for a minimum of 3 years. * Patients must not be pregnant or nursing, and all patients (both men and women) must be willing to practice birth control during and for 2 months after treatment with CC-8490. Women of childbearing potential (WCBP) who are sexually active must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner). * Patients must be able to swallow capsules whole. Exclusion Criteria: * 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. * Use of other experimental study drug within 28 days of registration.



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 InstituteBethesda, United StatesSee the location

CompletedOne Study Center
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