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CC-5013 in Treating Patients With Recurrent Glioma

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00036894
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 National Cancer Institute (NCI)
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Howard A. Fine, MD
Principal Investigator Affiliation NCI - Neuro-Oncology Branch
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 NIH
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain and Central Nervous System Tumors
Additional Details

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.#46;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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Bethesda, Maryland

Status

Address

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182

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