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A Phase II Trial to Evaluate the Effect of Low Dose Temozolomide (TMZ) for 2 Weeks on Brain Tumor O-6-methylguanine-DNA Methyltransferase (MGMT) Activity in Patients With Gliomas.


Phase 2
18 Years
75 Years
Not Enrolling
Both
Glioma

Thank you

Trial Information

A Phase II Trial to Evaluate the Effect of Low Dose Temozolomide (TMZ) for 2 Weeks on Brain Tumor O-6-methylguanine-DNA Methyltransferase (MGMT) Activity in Patients With Gliomas.


Inclusion Criteria:



- Presence of a brain tumor with high probability of being a glioma as detected by
Magnetic Resonance Imaging (MRI). These would include newly diagnosed tumors or
potentially recurrent gliomas.

- No prior treatment for the tumor including chemotherapy or radiotherapy.

- Amenable to surgery for biopsy or resection of the brain tumor. Surgically confirmed
diagnosis of glioma (glioblastoma multiforme [GBM], anaplastic astrocytoma [AA],
anaplastic oligodendroglioma [AO], anaplastic oligoastrocytoma [AOA], astrocytoma [A]
or oligodendroglioma [O]) will be required for patients to be maintained in the
study. Those not fulfilling this requirement will be discontinued and will be
replaced.

- Use of medically approved contraception in fertile males and females.

- Women with childbearing potential must have a negative urine or serum pregnancy test
(urinary excretion or serum level of beta-Human Chorionic Gonadotropin [bHCG]) within
72 hours of randomization.

- Karnofsky Performance Status score >= 70%.

- Signed informed consent form

Exclusion Criteria:

- Prior chemotherapy.

- Prior radiotherapy at the tumor site.

- History of non-compliance to other therapies.

- Inadequate haematological, renal and hepatic function according to all of the
following laboratory values (to be performed within 14 days, inclusive, prior to
study inclusion):

- Absolute neutrophil count ≤1.5 x 10^9/L;

- Platelets ≤100 x 10^9/L;

- Haemoglobin <90 g/L;

- Serum creatinine ≥1.5 times upper limit of laboratory normal;

- Total serum bilirubin ≥1.5 times upper limit of laboratory normal (ULN);

- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.0 ULN;

- Alkaline phosphatase of > 2.5 ULN.

- Known Human Immunodeficiency Virus [HIV] infection.

- Known chronic hepatitis B or hepatitis C infection.

- Any other serious medical condition according to the medical judgment of the
physician prior to inclusion in the study.

- Any medical condition, which could interfere with oral medication intake (e.g.,
frequent vomiting, partial bowel obstruction).

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

MethylGuanine-DNA MethylTransferase [MGMT] Activity Measured From the Tumor Tissue During Surgery

Outcome Description:

An experimental assay was developed to measure MGMT levels.

Outcome Time Frame:

14 days

Safety Issue:

No

Authority:

Canada: Health Canada

Study ID:

P04602

NCT ID:

NCT00424554

Start Date:

September 2006

Completion Date:

February 2011

Related Keywords:

  • Glioma
  • Brain Neoplasms
  • Glioma

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