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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00424554
First received: January 18, 2007
Last updated: July 18, 2012
Last verified: June 2011

January 18, 2007
July 18, 2012
September 2006
January 2010   (final data collection date for primary outcome measure)
MethylGuanine-DNA MethylTransferase [MGMT] Activity Measured From the Tumor Tissue During Surgery [ Time Frame: 14 days ] [ Designated as safety issue: No ]
An experimental assay was developed to measure MGMT levels.
Not Provided
Complete list of historical versions of study NCT00424554 on ClinicalTrials.gov Archive Site
  • Safety: Number of Participants Who Experienced Grade 3 or 4 Toxicities [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

    Grade 3 was defined as severe per Common Terminology Criteria for Adverse Events (CTCAE).

    Grade 4 was defined as life-threatening per CTCAE.

  • Tolerability: Number of Participants Discontinuing Treatment Due to Adverse Events (AE) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    An AE was defined as any event which was adverse, including what were commonly described as adverse or undesirable experiences, adverse events, adverse reactions, side effects, or death due to any cause associated with, or observed in conjunction with the use of a drug, biological product, or device in humans, whether or not considered related to the use of that product. Additionally, any event which was associated with, or observed in conjunction with product overdose whether accidental or intentional, or product abuse and/or withdrawal was also considered an AE.
  • Concentrations of Temozolomide in the Serum, Cerebrospinal Fluid, and Brain Tumor [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    No data available: at the time of tumor collection, the temozolomide levels were below the detection limits of the assay.
  • MGMT Activity in the Brain Tumor Tissues by Temozolomide Levels [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    No data available: at the time of tumor collection, the temozolomide levels were below the detection limits of the assay.
Not Provided
Not Provided
Not Provided
 
Low-dose Temozolomide for 2 Weeks on Brain Tumor Enzyme in Patients With Gliomas (P04602 AM1) (Completed)
A Phase II Trial to Evaluate the Effect of Low Dose Temozolomide (TMZ) for 2 Weeks on Brain Tumor O-6-methylguanine-DNA Methyltransferase (MGMT) Activity in Patients With Gliomas.

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Glioma
Drug: 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.

Other Name: SCH 052365
  • Experimental: Temozolomide treatment
    Intervention: Drug: temozolomide
  • No Intervention: No treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
February 2011
January 2010   (final data collection date for primary outcome measure)

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).
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00424554
P04602
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP