Comparison of Two Dosing Regimens of Temozolomide in Patients With Progressive or Recurrent Glioblastoma

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00941460
• Date of registration: 16/07/2009
• Primary sponsor: Prof. Dr. Wolfgang Wick
• Public title: Comparison of Two Dosing Regimens of Temozolomide in Patients With Progressive or Recurrent Glioblastoma DIRECTOR
• Scientific title: Dose-intensified Rechallenge With Temozolomide, One Week On One Week Off Versus Three Weeks On One Week Off in Patients With Progressive or Recurrent Glioblastoma
• Date of first enrolment: September 2009
• Target sample size: 166
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00941460
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Austria, Germany, Switzerland

Contacts

• Name: Michael Weller, Prof. Dr.
• Affiliation: University of Zurich

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Glioblastoma

Intervention(s)

Drug: Temozolomide in both arms

Primary Outcome(s)

Median time to treatment failure. Treatment failure is reached (i) upon tumor progression as outlined in protocol (ii) if treatment has to be terminated due to toxicity or (iii) if the patient dies for any reason. [Time Frame: up to one year]

Secondary Outcome(s)

progression free survival [Time Frame: up to two years]

Secondary ID(s)

2008-006871-60

DIRECTOR

ISRCTN68738654

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Essex Pharma GmbH