Completed

A Phase I Trial Of CC-8490 For The Treatment Of Patients 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

Glioma
+9

+ Neoplasms
+ Neoplasms by Histologic Type
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 SponsorNational Cancer Institute (NCI)
Last updated: January 14, 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.

OBJECTIVES: Primary * Determine the maximum tolerated dose of CC-8490 in patients with recurrent or refractory high-grade gliomas. * Determine, preliminarily, the toxic effects of this drug in these patients. * Determine the pharmacokinetics of this drug in these patients. Secondary * Determine, preliminarily, the potential anti-glioma activity of this drug in these patients. OUTLINE: This is a dose-escalation study. Patients receive oral CC-8490 once daily on days 1 and 3-28 (course 1 only). Beginning with course 2 and for all subsequent courses, patients receive oral CC-8490 once daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of CC-8490 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, a total of 10 patients are treated at that dose. Patients are followed within 2 weeks. PROJECTED ACCRUAL: A total of 34 patients will be accrued for this study.

Official TitleA Phase I Trial Of CC-8490 For The Treatment Of Patients With Recurrent/Refractory High-Grade Gliomas 
NCT00071864NCT00074243
Principal SponsorNational Cancer Institute (NCI)
Last updated: January 14, 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.
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 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
Glioma
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Nervous System Diseases
Nervous System Neoplasms
Central Nervous System Neoplasms
Neuroectodermal Tumors
Neoplasms, Neuroepithelial
Criteria

DISEASE CHARACTERISTICS: * Histologically confirmed supratentorial malignant glioma, including any of the following: * Glioblastoma multiforme * Gliosarcoma * Anaplastic astrocytoma * Anaplastic oligodendroglioma * Anaplastic mixed oligoastrocytoma * Malignant glioma/astrocytoma not otherwise specified OR * Clinical and radiographic diagnosis of progressive low-grade glioma * Radiographically diagnosed infiltrating brain stem gliomas not amenable to biopsy allowed * Recurrent or progressive disease as determined by 1 of the following: * CT scan or MRI within the past 21 days * Biopsy within the past 12 weeks * Failed prior radiotherapy PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 60-100% Life expectancy * More than 8 weeks Hematopoietic * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 (transfusion independent) * Hemoglobin at least 8 g/dL (transfusion allowed) Hepatic * Bilirubin no greater than 1.5 mg/dL * AST and ALT no greater than 2 times upper limit of normal * No significant active hepatic disease that would preclude study participation Renal * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance at least 60 mL/min * No significant active renal disease that would preclude study participation Cardiovascular * No significant active cardiac disease that would preclude study participation Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 2 months after study participation * No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix * No significant active psychiatric disease that would preclude study participation * No other condition or laboratory abnormality that would preclude study participation * Able to swallow capsules whole PRIOR CONCURRENT THERAPY: Biologic therapy * At least 2 weeks since prior interferon * No concurrent immunotherapy Chemotherapy * At least 2 weeks since prior vincristine * At least 3 weeks since prior procarbazine * At least 4 weeks since prior temozolomide or carboplatin * At least 6 weeks since prior nitrosoureas * No other concurrent anticancer chemotherapy Endocrine therapy * At least 2 weeks since prior tamoxifen * Concurrent steroids allowed provided dose has been stable for at least 5 days prior to study enrollment Radiotherapy * See Disease Characteristics * At least 2 weeks since prior radiotherapy * No concurrent radiotherapy Surgery * At least 2 weeks since prior resection of a recurrent or progressive tumor Other * At least 2 weeks since other prior non-cytotoxic therapy * At least 4 weeks since other prior cytotoxic therapies * More than 28 days since prior experimental study drugs * No other concurrent investigational agents

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
Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, United StatesSee the location
CompletedOne Study Center