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A Phase I Trial Of A Thalidomide Analog, CC-5013, For The Treatment Of Patients With Recurrent High-Grade Gliomas

Phase 1
18 Years
Not Enrolling
Brain and Central Nervous System Tumors

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Trial Information

A Phase I Trial Of A Thalidomide Analog, CC-5013, For The Treatment Of Patients With Recurrent High-Grade Gliomas


- Determine the maximum tolerated dose of CC-5013 in patients with recurrent high-grade

- 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.

Inclusion Criteria


- 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



- 18 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- More than 8 weeks


- WBC at least 2,300/mm^3

- Platelet count at least 90,000/mm^3

- Hemoglobin at least 8 g/dL (transfusions allowed)


- Bilirubin less than 3 times upper limit of normal (ULN)

- SGOT less than 3 times ULN

- No significant active hepatic disease


- Creatinine less than 2.0 mg/dL OR

- Creatinine clearance at least 60 mL/min

- No significant active renal disease


- No significant active cardiac disease


- 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


Biologic therapy:

- At least 2 weeks since prior interferon

- No concurrent immunotherapy


- 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


- See Disease Characteristics

- At least 2 weeks since prior radiotherapy

- No concurrent radiotherapy


- See Disease Characteristics

- At least 2 weeks since prior tumor resection


- 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Howard A. Fine, MD

Investigator Role:

Study Chair

Investigator Affiliation:

NCI - Neuro-Oncology Branch


United States: Federal Government

Study ID:




Start Date:

March 2002

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent adult brain tumor
  • adult glioblastoma
  • adult anaplastic astrocytoma
  • adult anaplastic oligodendroglioma
  • adult mixed glioma
  • adult ependymoblastoma
  • adult anaplastic ependymoma
  • adult myxopapillary ependymoma
  • adult meningioma
  • adult meningeal hemangiopericytoma
  • adult brain stem glioma
  • adult grade III meningioma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms



Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support Bethesda, Maryland  20892-1182