Low-dose Temozolomide for 2 Weeks on Brain Tumor Enzyme in Patients With Gliomas (P04602 AM1) (Completed)
Condition: Glioma
MeSH terms: Glioma
Intervention: temozolomide
Intervention description: Temozolomide 75 mg/m^2 daily for 14 days prior to surgery.
As standard of care, it could also be given at the same dose for up to 28 days after surgery, per investigator discretion.
Intervention MeSH terms: Temozolomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to assess the effect of a two-week pre-surgery treatment
      with low-dose temozolomide (TMZ) on brain tumor methylguanine-DNA (deoxyribonucleic acid)
      methyltransferase (MGMT) activity in patients with gliomas.
    

Eligibility criteria:

        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).