CC-5013 in Treating Patients With Recurrent Glioma

April 29, 2015 updated by: National Cancer Institute (NCI)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Study Registration Dates

First Submitted

May 13, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

April 30, 2015

Last Update Submitted That Met QC Criteria

April 29, 2015

Last Verified

November 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000069338
  • NCI-02-C-0145

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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