NCT00074243CompletedPhase 1
A Phase I Trial Of CC-8490 For The Treatment Of Patients With Recurrent/Refractory High-Grade Gliomas
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Locations
- 1
Study Overview
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as CC-8490, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of CC-8490 in treating patients who have recurrent or refractory high-grade gliomas.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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:
- •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)
- •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
- •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
- •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
- +11 more not shown
Exclusion Criteria
- Not provided
Investigators
Study Sites (1)
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