cropped color_logo_with_background.png

Clinical Trial Finder

CC-8490 in Treating Patients With Recurrent or Refractory High-Grade Gliomas

Study Purpose

RATIONALE: Drugs used in chemotherapy, such as CC-8490, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of CC-8490 in treating patients who have recurrent or refractory high-grade gliomas.

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:

  • - Histologically confirmed supratentorial malignant glioma, including any of the following: - Glioblastoma multiforme.
  • - Gliosarcoma.
  • - Anaplastic astrocytoma.
  • - Anaplastic oligodendroglioma.
  • - Anaplastic mixed oligoastrocytoma.
  • - Malignant glioma/astrocytoma not otherwise specified OR.
  • - Clinical and radiographic diagnosis of progressive low-grade glioma.
  • - Radiographically diagnosed infiltrating brain stem gliomas not amenable to biopsy allowed.
  • - Recurrent or progressive disease as determined by 1 of the following: - CT scan or MRI within the past 21 days.
  • - Biopsy within the past 12 weeks.
  • - Failed prior radiotherapy.
PATIENT CHARACTERISTICS: Age.
  • - 18 and over.
Performance status.
  • - Karnofsky 60-100% Life expectancy.
  • - More than 8 weeks.
Hematopoietic.
  • - Granulocyte count at least 1,500/mm^3.
  • - Platelet count at least 100,000/mm^3 (transfusion independent) - Hemoglobin at least 8 g/dL (transfusion allowed) Hepatic.
  • - Bilirubin no greater than 1.5 mg/dL.
  • - AST and ALT no greater than 2 times upper limit of normal.
  • - No significant active hepatic disease that would preclude study participation.
Renal.
  • - Creatinine no greater than 1.5 mg/dL OR.
  • - Creatinine clearance at least 60 mL/min.
  • - No significant active renal disease that would preclude study participation.
Cardiovascular.
  • - No significant active cardiac disease that would preclude study participation.
Other.
  • - Not pregnant or nursing.
  • - Negative pregnancy test.
  • - Fertile patients must use effective contraception during and for 2 months after study participation.
  • - No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix.
  • - No significant active psychiatric disease that would preclude study participation.
  • - No other condition or laboratory abnormality that would preclude study participation.
  • - Able to swallow capsules whole.
PRIOR CONCURRENT THERAPY: Biologic therapy.
  • - At least 2 weeks since prior interferon.
  • - No concurrent immunotherapy.
Chemotherapy.
  • - At least 2 weeks since prior vincristine.
  • - At least 3 weeks since prior procarbazine.
  • - At least 4 weeks since prior temozolomide or carboplatin.
  • - At least 6 weeks since prior nitrosoureas.
  • - No other concurrent anticancer chemotherapy.
Endocrine therapy.
  • - At least 2 weeks since prior tamoxifen.
  • - Concurrent steroids allowed provided dose has been stable for at least 5 days prior to study enrollment.
Radiotherapy.
  • - See Disease Characteristics.
  • - At least 2 weeks since prior radiotherapy.
  • - No concurrent radiotherapy.
Surgery.
  • - At least 2 weeks since prior resection of a recurrent or progressive tumor.
Other.
  • - At least 2 weeks since other prior non-cytotoxic therapy.
  • - At least 4 weeks since other prior cytotoxic therapies.
  • - More than 28 days since prior experimental study drugs.
- 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.

 NCT00074243
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: Primary.

  • - Determine the maximum tolerated dose of CC-8490 in patients with recurrent or refractory high-grade gliomas.
  • - Determine, preliminarily, the toxic effects of this drug in these patients.
  • - Determine the pharmacokinetics of this drug in these patients.
Secondary.
  • - Determine, preliminarily, the potential anti-glioma activity of this drug in these patients.
OUTLINE: This is a dose-escalation study. Patients receive oral CC-8490 once daily on days 1 and 3-28 (course 1 only). Beginning with course 2 and for all subsequent courses, patients receive oral CC-8490 once daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of CC-8490 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, a total of 10 patients are treated at that dose. Patients are followed within 2 weeks. PROJECTED ACCRUAL: A total of 34 patients will be accrued for this study.

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

Powered By