Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00424554
Other study ID # P04602
Secondary ID
Status Completed
Phase Phase 2
First received January 18, 2007
Last updated May 15, 2017
Start date September 26, 2006
Est. completion date February 16, 2011

Study information

Verified date May 2017
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date February 16, 2011
Est. primary completion date January 11, 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type Measure Description Time frame Safety issue
Primary MethylGuanine-DNA MethylTransferase [MGMT] Activity Measured From the Tumor Tissue During Surgery An experimental assay was developed to measure MGMT levels. 14 days
Secondary Safety: Number of Participants Who Experienced Grade 3 or 4 Toxicities Grade 3 was defined as severe per Common Terminology Criteria for Adverse Events (CTCAE).
Grade 4 was defined as life-threatening per CTCAE.
12 months
Secondary Tolerability: Number of Participants Discontinuing Treatment Due to Adverse Events (AE) 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. 12 months
Secondary Concentrations of Temozolomide in the Serum, Cerebrospinal Fluid, and Brain Tumor No data available: at the time of tumor collection, the temozolomide levels were below the detection limits of the assay. 14 days
Secondary MGMT Activity in the Brain Tumor Tissues by Temozolomide Levels No data available: at the time of tumor collection, the temozolomide levels were below the detection limits of the assay. 14 days
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04539574 - An Investigational Scan (7T MRI) for the Imaging of Central Nervous System Tumors N/A
Enrolling by invitation NCT04461002 - Evaluation of the Correlation Between Molecular Phenotype and Radiological Signature (by PET-scanner and MRI) of Incident WHO II and III Grade Gliomas.
Terminated NCT01902771 - Dendritic Cell Vaccine Therapy With In Situ Maturation in Pediatric Brain Tumors Phase 1
Completed NCT03242824 - The Utility of 18F-DOPA-PET in the Treatment of Recurrent High-grade Glioma Phase 2
Recruiting NCT04186832 - Step Count Monitoring as a Measure of Physical Activity in Patients With Newly Diagnosed Glioma Undergoing Radiation Therapy N/A
Recruiting NCT05968053 - Detection of Microplastics and Nanoplastics in Neurosurgery Patients (DT-MiNi)
Not yet recruiting NCT04550663 - NKG2D CAR-T(KD-025) in the Treatment of Relapsed or Refractory NKG2DL+ Tumors Phase 1
Completed NCT02805179 - A Study of High-Dose Chemoradiation Using Biologically-Based Target Volume Definition in Patients With Glioblastoma Phase 2
Terminated NCT04556929 - Enhanced Detection in Glioma Excision N/A
Not yet recruiting NCT06408428 - Glioma Intraoperative MicroElectroCorticoGraphy N/A
Recruiting NCT06043232 - MMR/MSI Phenotypes in Prediction of Tumor Vaccine Benefit for Gliomas
Not yet recruiting NCT06043765 - Reducing Cognitive Impairment in Glioma With Repetitive Transcranial Magnetic Stimulation and Cognitive Strategy Training N/A
Not yet recruiting NCT05025969 - Evaluation of the Incidence of NTRK Gene Fusion in Adult Brain Tumours
Completed NCT02978261 - Study of a c-Met Inhibitor PLB1001 in Patients With PTPRZ1-MET Fusion Gene Positive Recurrent High-grade Gliomas Phase 1
Terminated NCT01502605 - Phase I Study of Orally Administered Aminolevulinic Acid for Resection of Malignant Astrocytomas Phase 1
Completed NCT01836536 - Search for a Link Between Response to Treatment and Circulating Leucocytes in High Grade Glioma Patients N/A
Completed NCT01479686 - iMRI Guided Resection in Cerebral Glioma Surgery Phase 3
Completed NCT01212731 - Skull Base and Low Grade Glioma Neurocognitive Magnetic Resonance Imaging (MRI) Study
Withdrawn NCT00985036 - Vascular Endothelial Growth Factor (VEGF) Levels in Brain Tumor Patients N/A
Terminated NCT01044966 - A Study of Intraventricular Liposomal Encapsulated Ara-C (DepoCyt) in Patients With Recurrent Glioblastoma Phase 1/Phase 2