CC-8490 in Treating Patients With Recurrent or Refractory High-Grade Gliomas
|Phase I||Treatment||Completed||18 and over||NCI||NCI-04-C-0035|
- 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.
- Determine, preliminarily, the potential anti-glioma activity of this drug in these patients.
- Histologically confirmed supratentorial malignant glioma, including any of the following:
- Glioblastoma multiforme
- Anaplastic astrocytoma
- Anaplastic oligodendroglioma
- Anaplastic mixed oligoastrocytoma
- Malignant glioma/astrocytoma not otherwise specified
- 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
- At least 2 weeks since prior interferon
- No concurrent immunotherapy
- 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
- At least 2 weeks since prior tamoxifen
- Concurrent steroids allowed provided dose has been stable for at least 5 days prior to study enrollment
- See Disease Characteristics
- At least 2 weeks since prior radiotherapy
- No concurrent radiotherapy
- At least 2 weeks since prior resection of a recurrent or progressive tumor
- 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
- 18 and over
- Karnofsky 60-100%
- More than 8 weeks
- Granulocyte count at least 1,500/mm3
- Platelet count at least 100,000/mm3 (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
- Creatinine clearance at least 60 mL/min
- No significant active renal disease that would preclude study participation
- 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
A total of 34 patients will be accrued for this study.
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.
Trial Lead Organizations
NCI - Center for Cancer Research
|Howard Fine, MD, Principal investigator|
|Official Title||A Phase I Trial Of CC-8490 For The Treatment Of Patients With Recurrent/Refractory High-Grade Gliomas|
|Trial Start Date||2003-12-07|
|Registered in ClinicalTrials.gov||NCT00074243|
|Date Submitted to PDQ||2003-10-29|
|Information Last Verified||2006-11-20|
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.