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

NCT ID: NCT00424554

Last Updated: 2017-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-26
• Study Completion Date: 2011-02-16

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 (MGMT) activity in patients with gliomas.

Conditions

Glioma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Temozolomide treatment

Group Type: EXPERIMENTAL

temozolomide

Intervention Type: DRUG

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.

No treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

temozolomide

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 Type: DRUG

Other Intervention Names

SCH 052365

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P04602

Identifier Type: -

Identifier Source: org_study_id