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Sorafenib in Treating Patients With Recurrent or Progressive Malignant Glioma
This study is ongoing, but not recruiting participants.
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00093613
  Purpose

RATIONALE: Sorafenib may stop the growth of tumor cells by stopping blood flow to the tumor and by blocking the enzymes necessary for their growth.

PURPOSE: This phase I trial is studying the side effects and best dose of sorafenib in treating patients with recurrent or progressive malignant glioma


Condition Intervention Phase
Brain and Central Nervous System Tumors
Drug: sorafenib tosylate
Phase I

MedlinePlus related topics: Cancer
Drug Information available for: Sorafenib Sorafenib tosylate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase I Trial of BAY 43-9006 for Patients With Recurrent or Progressive Malignant Glioma

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

Estimated Enrollment: 36
Study Start Date: November 2004
Detailed Description:

OBJECTIVES:

  • Determine the maximum tolerated dose of sorafenib in patients with recurrent or progressive malignant glioma who are receiving or not receiving enzyme-inducing anticonvulsant drugs (EIACDs).
  • Determine dose-related toxic effects of this drug in these patients.
  • Compare pharmacokinetics of this drug in patients receiving or not receiving EIACDs.
  • Determine overall survival of patients treated with this drug.

OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to the concurrent use of cytochrome P450-inducing anticonvulsants (yes vs no).

Patients receive oral sorafenib twice daily on days 1-28 (once daily on day 1 of course 1 only). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients per stratum receive escalating doses of sorafenib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 3 of 6 patients experience dose-limiting toxicity.

Patients are followed every 2 months.

PROJECTED ACCRUAL: A total of 6-36 patients will be accrued for this study within 3-18 months.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed malignant glioma (anaplastic astrocytoma, anaplastic oligodendroglioma, or glioblastoma multiforme)

    • Progressive or recurrent disease after prior radiotherapy with or without chemotherapy
    • Low-grade glioma that progressed to high-grade glioma after prior radiotherapy with or without chemotherapy allowed
  • Measurable disease by MRI or CT scan

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Karnofsky 60-100%

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • No bleeding diathesis

Hepatic

  • Bilirubin ≤ 1.5 mg/dL
  • Transaminases ≤ 4 times upper limit of normal
  • PT/PTT normal
  • INR normal

Renal

  • Creatinine ≤ 1.7 mg/dL

Cardiovascular

  • No uncontrolled hypertension
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for 8 weeks after study participation
  • Mini Mental State exam score ≥ 15
  • No serious infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No other medical illness that would preclude study participation
  • No other malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent prophylactic filgrastim (G-CSF)
  • No concurrent immunotherapy

Chemotherapy

  • See Disease Characteristics
  • At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)
  • No concurrent chemotherapy

Endocrine therapy

  • Concurrent steroids allowed
  • No concurrent hormonal therapy

Radiotherapy

  • See Disease Characteristics
  • At least 3 months since prior radiotherapy
  • No concurrent radiotherapy

Surgery

  • No concurrent surgery

Other

  • Recovered from all prior therapy
  • No enzyme-inducing anticonvulsant drugs for at least 10 days before starting non-enzyme-inducing anticonvulsant drugs
  • No more than 1 prior treatment for cancer
  • No concurrent therapeutic anticoagulation

    • Concurrent prophylactic anticoagulation (i.e., low-dose warfarin) for venous or arterial access devices allowed
  • No other concurrent investigational agents
  • No other concurrent anticancer therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00093613

Locations
United States, Alabama
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
Birmingham, Alabama, United States, 35294
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States, 33612-9497
United States, Georgia
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States, 30322
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
United States, Ohio
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
Sponsors and Collaborators
Investigators
Study Chair: Louis B. Nabors, MD Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Nabors LB, Rosenfeld M, Chamberlain M, et al.: A phase I trial of sorafenib (BAY 43-9006) for patients with recurrent or progressive malignant glioma (NABTT 0401). [Abstract] J Clin Oncol 25 (Suppl 18): A-2058, 2007.

Study ID Numbers: CDR0000389245, NABTT-0401, JHOC-NABTT-0401
Study First Received: October 6, 2004
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00093613  
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
adult anaplastic oligodendroglioma
adult anaplastic astrocytoma
adult giant cell glioblastoma
adult gliosarcoma
recurrent adult brain tumor

Study placed in the following topic categories:
Glioblastoma
Astrocytoma
Central Nervous System Neoplasms
Recurrence
Brain Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Oligodendroglioma
Glioma
Gliosarcoma
Sorafenib
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Neoplasms, Nerve Tissue
Nervous System Diseases
Enzyme Inhibitors
Neoplasms, Neuroepithelial
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009