CC-5013 in Treating Patients With Recurrent Glioma

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00036894
First received: May 13, 2002
Last updated: December 13, 2008
Last verified: November 2003
  Purpose

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 Intervention Phase
Brain and Central Nervous System Tumors
Drug: lenalidomide
Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: March 2002
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00036894

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
Investigators
Study Chair: Howard A. Fine, MD NCI - Neuro-Oncology Branch
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00036894     History of Changes
Obsolete Identifiers: NCT00032214
Other Study ID Numbers: CDR0000069338, NCI-02-C-0145
Study First Received: May 13, 2002
Last Updated: December 13, 2008
Health Authority: United States: Federal Government

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:
Glioma
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Lenalidomide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014