Back to resultsLow-dose Temozolomide for 2 Weeks on Brain Tumor Enzyme in Patients With Gliomas (P04602 AM1) (Completed)
Primary Purpose
Glioma
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
temozolomide
Sponsored by
About this trial
This is an interventional treatment trial for Glioma
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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Temozolomide treatment
No treatment
Arm Description
Outcomes
Primary Outcome Measures
MethylGuanine-DNA MethylTransferase [MGMT] Activity Measured From the Tumor Tissue During Surgery
An experimental assay was developed to measure MGMT levels.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00424554
Brief Title
Low-dose Temozolomide for 2 Weeks on Brain Tumor Enzyme in Patients With Gliomas (P04602 AM1) (Completed)
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
September 26, 2006 (Actual)
Primary Completion Date
January 11, 2010 (Actual)
Study Completion Date
February 16, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Temozolomide treatment
Arm Type
Experimental
Arm Title
No treatment
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
temozolomide
Other Intervention Name(s)
SCH 052365
Intervention Description
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.
Primary Outcome Measure Information:
Title
MethylGuanine-DNA MethylTransferase [MGMT] Activity Measured From the Tumor Tissue During Surgery
Description
An experimental assay was developed to measure MGMT levels.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Safety: Number of Participants Who Experienced Grade 3 or 4 Toxicities
Description
Grade 3 was defined as severe per Common Terminology Criteria for Adverse Events (CTCAE).
Grade 4 was defined as life-threatening per CTCAE.
Time Frame
12 months
Title
Tolerability: Number of Participants Discontinuing Treatment Due to Adverse Events (AE)
Description
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.
Time Frame
12 months
Title
Concentrations of Temozolomide in the Serum, Cerebrospinal Fluid, and Brain Tumor
Description
No data available: at the time of tumor collection, the temozolomide levels were below the detection limits of the assay.
Time Frame
14 days
Title
MGMT Activity in the Brain Tumor Tissues by Temozolomide Levels
Description
No data available: at the time of tumor collection, the temozolomide levels were below the detection limits of the assay.
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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).
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
Learn more about this trial
Low-dose Temozolomide for 2 Weeks on Brain Tumor Enzyme in Patients With Gliomas (P04602 AM1) (Completed)
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