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CC-5013 in Treating Patients With Recurrent Glioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00036894
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 30, 2015
Information provided by:
National Cancer Institute (NCI)

Brief 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.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Drug: lenalidomide Phase 1

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase I Trial Of A Thalidomide Analog, CC-5013, For The Treatment Of Patients With Recurrent High-Grade Gliomas
Study Start Date : March 2002

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00036894

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United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
National Cancer Institute (NCI)
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Study Chair: Howard A. Fine, MD NCI - Neuro-Oncology Branch
Publications of Results:
Layout table for additonal information Identifier: NCT00036894    
Obsolete Identifiers: NCT00032214
Other Study ID Numbers: CDR0000069338
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: April 30, 2015
Last Verified: November 2003
Keywords provided by National Cancer Institute (NCI):
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
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents