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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00074243
First received: December 10, 2003
Last updated: December 13, 2008
Last verified: November 2006
  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.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: CC-8490
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Trial Of CC-8490 For The Treatment Of Patients With Recurrent/Refractory High-Grade Gliomas

Resource links provided by NLM:


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

Study Start Date: December 2003
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00074243

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00074243     History of Changes
Obsolete Identifiers: NCT00071864
Other Study ID Numbers: CDR0000343702, NCI-04-C-0035
Study First Received: December 10, 2003
Last Updated: December 13, 2008
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adult anaplastic astrocytoma
adult anaplastic oligodendroglioma
adult glioblastoma
adult mixed glioma
adult brain stem glioma
recurrent adult brain tumor
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

ClinicalTrials.gov processed this record on April 16, 2014