Expired Study
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Bethesda, Maryland 20892


Purpose:

RATIONALE: CC-5013 may stop the growth of gliomas by stopping blood flow to the tumor. PURPOSE: Phase I trial to study the effectiveness of CC-5013 in treating patients who have recurrent glioma.


Study summary:

OBJECTIVES: - Determine the maximum tolerated dose of CC-5013 in patients with recurrent high-grade gliomas. - Determine the toxic effects of this drug in these patients. - Determine the pharmacokinetics of this drug in these patients. - Determine the antiangiogenic activity of this drug in these patients. OUTLINE: This is a dose-escalation study. Patients are stratified according to concurrent enzyme-inducing antiepileptic drugs (yes vs no). Patients receive oral CC-5013 weekly for 3 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of CC-5013 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 2 weeks. PROJECTED ACCRUAL: A maximum of 80 patients (40 per stratum) will be accrued for this study within 20 months.


Criteria:

DISEASE CHARACTERISTICS: - One of the following: - Histologically confirmed high-grade glioma - Glioblastoma multiforme - Gliosarcoma - Anaplastic astrocytoma - Anaplastic oligodendroglioma - Anaplastic mixed oligoastrocytoma - Malignant glioma/astrocytoma, not otherwise specified - Meningioma - Hemangioblastoma - Ependymoma - Primitive neuroectodermal tumors - Hemangiopericytoma - Progressive glioma - Clinically and radiographically diagnosed brain stem glioma - Progressive or recurrent disease as determined by CT scan or MRI - Biopsy allowed for prior recent (i.e., within the past 12 weeks) resection of recurrent or progressive tumor - Must have failed prior radiotherapy PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - More than 8 weeks Hematopoietic: - WBC at least 2,300/mm^3 - Platelet count at least 90,000/mm^3 - Hemoglobin at least 8 g/dL (transfusions allowed) Hepatic: - Bilirubin less than 3 times upper limit of normal (ULN) - SGOT less than 3 times ULN - No significant active hepatic disease Renal: - Creatinine less than 2.0 mg/dL OR - Creatinine clearance at least 60 mL/min - No significant active renal disease Cardiovascular: - No significant active cardiac disease Other: - No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix - No significant active psychiatric disease - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 2 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 2 weeks since prior interferon - No concurrent immunotherapy Chemotherapy: - At least 6 weeks since prior nitrosoureas - At least 4 weeks since prior temozolomide or carboplatin - At least 3 weeks since prior procarbazine - At least 2 weeks since prior vincristine - At least 4 weeks since other prior cytotoxic chemotherapy - No concurrent chemotherapy Endocrine therapy: - At least 2 weeks since prior tamoxifen - Concurrent steroids allowed for control of the signs and symptoms of increased intracranial pressure if on a stable dose for at least the past 5 days Radiotherapy: - See Disease Characteristics - At least 2 weeks since prior radiotherapy - No concurrent radiotherapy Surgery: - See Disease Characteristics - At least 2 weeks since prior tumor resection Other: - At least 2 weeks since other prior noncytotoxic agents - Concurrent enzyme-inducing antiepileptic drugs allowed - No concurrent rifampin - No concurrent grapefruit juice - No other concurrent investigational agents


NCT ID:

NCT00036894


Primary Contact:

Study Chair
Howard A. Fine, MD
NCI - Neuro-Oncology Branch


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 17, 2017

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