Status:
COMPLETED
Comparison of Two Dosing Regimens of Temozolomide in Patients With Progressive or Recurrent Glioblastoma
Lead Sponsor:
Prof. Dr. Wolfgang Wick
Collaborating Sponsors:
Essex Pharma GmbH
Conditions:
Glioblastoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
For patients with progressive or recurrent glioblastoma there is no standard therapy. One strategy is re-exposure to temozolomide in a higher dose. This increase in dosing can be done by 2 regimens. A...
Eligibility Criteria
Inclusion
- Progressive or recurrent glioblastoma documented by MRI no earlier than 180 days after first surgery for glioblastoma and no earlier than 90 days after completion of radiotherapy.
- Histological diagnosis of glioblastoma
- Tissue available for the determination of MGMT promoter methylation in the primary tumor or from the recurrent tumor if a patient undergoes a surgical procedure at recurrence prior to study entry.
- Prior treatment with temozolomide administered concomitantly with radiotherapy and at least for two cycles (5/28) as an adjuvant treatment
- Informed consent
- Age 18-80 years
- Karnofsky performance score \> 50%
- Neutrophil counts \> 1 500/µl
- Platelet counts \> 100 000/µl
- Hemoglobin \> 10 g/dl
- Serum creatinin \< 1.5-fold upper normal range
- ASAT or ALAT \< 3-fold upper normal range unless attributed to anticonvulsants
- Alkaline phosphatase \< 3-fold upper normal range
- Women with childbearing potential must have a negative serum pregnancy test ≤14 days prior to study enrollment
- Willingness to apply contraception according to local requirements (as stated in patient information)
Exclusion
- Progressive or recurrent glioblastoma documented by MRI earlier than 180 days after first surgery for glioblastoma and earlier than 90 days after completion of radiotherapy.
- Treatment with any chemotherapy other than temozolomide according to the schedule of the EORTC NCIC trial (Stupp et al. N Engl J Med 2005;352:987-996) except that an adjuvant starting dose of 200 mg/m2 and more than 6 cycles of adjuvant temozolomide are allowed
- Prior systemic or local treatment with DNA-damaging agents, tyrosine kinase inhibitors or anti-angiogenic agents for any cancer
- Allergy to or other intolerability of temozolomide
- Unable to undergo MRI
- Past medical history of diseases with poor prognosis, e.g. severe coronary heart disease, severe diabetes, immune deficiency, residual deficits after stroke, severe mental retardation
- HIV infection
- Pregnancy
- Breast feeding
- Treatment within in any other clinical trial parallel to the treatment phase of the current study
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00941460
Start Date
September 1 2009
End Date
June 1 2013
Last Update
August 15 2014
Active Locations (16)
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1
Landesnervenklinik Wagner-Jauregg
Linz, Austria, 4020
2
Medical University Vienna, Department of Internal Medicine I
Vienna, Austria, 1090
3
Charite, Department of Neurosurgery
Berlin, Germany, 13353
4
Knappschaftskrankenhaus, Department of Neurology
Bochum, Germany, 44892