Status:
COMPLETED
CC-8490 in Treating Patients With Recurrent or Refractory High-Grade Gliomas
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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-8...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00074243
Start Date
December 1 2003
Last Update
April 30 2015
Active Locations (1)
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1
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182