Status:
COMPLETED
Low-dose Temozolomide for 2 Weeks on Brain Tumor Enzyme in Patients With Gliomas (P04602 AM1) (Completed)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Glioma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 (...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 26 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 16 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00424554
Start Date
September 26 2006
End Date
February 16 2011
Last Update
June 7 2017
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