Phase 2
N=40
Low-dose Temozolomide for 2 Weeks on Brain Tumor Enzyme in Patients With Gliomas (P04602 AM1) (Completed)
Glioma
Bottom Line
View on ClinicalTrials.gov: NCT00424554 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jun 2011
Primary outcome: Primary: MethylGuanine-DNA MethylTransferase [MGMT] Activity Measured From the Tumor Tissue During Surgery — 333.7; 105.1 fmol/mg of proteins — p=0.09
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- temozolomide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY MethylGuanine-DNA MethylTransferase [MGMT] Activity Measured From the Tumor Tissue During Surgery |
333.7; 105.1 | 0.09 |
| SECONDARY Safety: Number of Participants Who Experienced Grade 3 or 4 Toxicities |
4; 0; 0; 0 | — |
| SECONDARY Tolerability: Number of Participants Discontinuing Treatment Due to Adverse Events (AE) |
0; 0 | — |
| SECONDARY Concentrations of Temozolomide in the Serum, Cerebrospinal Fluid, and Brain Tumor |
— | — |
| SECONDARY MGMT Activity in the Brain Tumor Tissues by Temozolomide Levels |
— | — |
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 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).
Data sourced from ClinicalTrials.gov (NCT00424554). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.