Low-dose Temozolomide for 2 Weeks on Brain Tumor Enzyme in Patients With Gliomas (P04602 AM1) (Completed)

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 2

Conditions

Glioma

Treatments

Drug: temozolomide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00424554

P04602

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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).