Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: CC-5013 in Treating Patients With Recurrent Glioma

Summary: 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.

Detailed description: 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.

Eligibility: 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

Relevance to patient case: not relevant