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 (DIRECTOR)

• Conditions: progressive or recurrent glioblastoma after first surgery for glioblastoma and after completion of radiotherapy; MedDRA version: 14.1Level: PTClassification code 10018337Term: Glioblastoma multiformeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2008-006871-60-AT
• Lead Sponsor: niversity Hospital Heidelberg, Ruprechts-Karl-University Heidelberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-31
• Last Update Posted: 23 September 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 166

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 gene promoter methylation in the recurrent tumor
•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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 166
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 166

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.
•Any other prior treatment 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 as well as more than 6 cycles of adjuvant temozolomide are allowed
•Allergy to or other intolerability of temozolomide
•Unable to undergo MRI
•Prior systemic or local treatment with DNA-damaging agents, tyosine kinase inhibitors or anti-angiogenic agents for any cancer
•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified