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A Phase I Trial of BAY 43-9006 for Patients With Recurrent or Progressive Malignant Glioma


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Adult Anaplastic Astrocytoma, Adult Anaplastic Oligodendroglioma, Adult Giant Cell Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Tumor

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Trial Information

A Phase I Trial of BAY 43-9006 for Patients With Recurrent or Progressive Malignant Glioma


PRIMARY OBJECTIVES:

I. To determine the maximum tolerated dose (MTD) of BAY 43-9006 when administered to adults
with recurrent malignant glioma, receiving (Group A) or not receiving (Group B)
anticonvulsants known to be metabolized by the P450 hepatic enzyme complex.

II. To assess and estimate the dose-related toxicities. III. To describe the
pharmacokinetics of this route of administration, measuring BAY 43-9006, and to assess the
pharmacokinetic difference between patients taking enzyme-inducing agents and those who are
not.

IV. To estimate overall survival.

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.


Inclusion Criteria:



- Patients must have histologically proven malignant glioma (anaplastic astrocytoma,
anaplastic oligodendroglioma or glioblastoma multiforme) which is progressive or
recurrent after radiation therapy ± chemotherapy; patients with previous low grade
glioma who progressed after radiotherapy ± chemotherapy and are biopsied and found to
have a high grade glioma are eligible

- Patients must have measurable progressive or recurrent malignant glioma by MRI or CT
imaging; (Within 14 days before starting treatment)

- Patients must have recovered from toxicity of prior therapy; an interval of at least
3 months must have elapsed since the completion of the most recent course of
radiation therapy, while at least 3 weeks must have elapsed since the completion of a
non-nitrosourea containing chemotherapy regimen, and at least 6 weeks since the
completion of a nitrosourea containing chemotherapy regimen

- Patients must have a Karnofsky performance status >= 60% (i.e. the patient must be
able to care for himself/herself with occasional help from others)

- Absolute Neutrophil Count >= 1500/mm^3

- Platelets >= 100,000/mm^3

- Creatinine =< 1.7mg/dl

- Total Bilirubin =< 1.5mg/dl

- Transaminases =< 4 times above the upper limits of the institutional norm

- PT, PTT, INR within institutional norm

- Patients must be able to provide written informed consent

- Patients with the potential for pregnancy or impregnating their partner must agree to
follow acceptable birth control methods to avoid conception; women of childbearing
potential must have a negative serum pregnancy test; (The anti-proliferative activity
of this experimental drug may be harmful to the developing fetus or nursing infant)

- Patients must have a Mini Mental State Exam score >= 15

Exclusion Criteria:

- Patients with serious concurrent infection or medical illness which would jeopardize
the ability of the patient to receive the treatment outlined in this protocol with
reasonable safety; (Examples of medical illnesses are [but not limited to] the
following: uncontrolled hypertension, symptomatic congestive heart failure, unstable
angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that
would limit compliance with study requirements)

- Patients who are pregnant or breast-feeding; (The anti-proliferative activity of this
experimental drug may be harmful to the developing fetus or nursing infant)

- Patients who have received more than two prior treatments

- Patients receiving concurrent therapy for their tumor (with the exception of
steroids)

- Patients with a concurrent malignancy are ineligible unless they are patients with
curatively treated carcinoma-in-situ or basal cell carcinoma of the skin; patients
with a prior malignancy are ineligible unless they have been free of disease for >=
five years

- Patients must not have any evidence of bleeding diathesis

- Patients must not be on therapeutic anticoagulation; prophylactic anticoagulation
(i.e. low dose warfarin) of venous or arterial access devices is allowed provided
that the requirements for PT, INR or PTT are met; (Patients will be taken off
treatment if they require therapeutic anticoagulation during BAY 43-9006 treatment)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose (MTD) of sorafenib tosylate in patients with recurrent or progressive malignant glioma, receiving (group A) or not receiving (group B) anticonvulsants known to be metabolized by the P450 hepatic enzyme complex

Outcome Time Frame:

28 days

Safety Issue:

Yes

Principal Investigator

Louis Nabors

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-03102

NCT ID:

NCT00093613

Start Date:

December 2004

Completion Date:

Related Keywords:

  • Adult Anaplastic Astrocytoma
  • Adult Anaplastic Oligodendroglioma
  • Adult Giant Cell Glioblastoma
  • Adult Gliosarcoma
  • Recurrent Adult Brain Tumor
  • Astrocytoma
  • Brain Neoplasms
  • Glioblastoma
  • Oligodendroglioma
  • Gliosarcoma
  • Glioma

Name

Location

Adult Brain Tumor ConsortiumBaltimore, Maryland  21231-1000