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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


Phase 2
18 Years
80 Years
Open (Enrolling)
Both
Glioblastoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

up to one year

Safety Issue:

Yes

Principal Investigator

Michael Weller, Prof. Dr.

Investigator Role:

Study Chair

Investigator Affiliation:

University of Zurich

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

DIRECTOR

NCT ID:

NCT00941460

Start Date:

September 2009

Completion Date:

August 2013

Related Keywords:

  • Glioblastoma
  • progressive or recurrent glioblastoma
  • temozolomide
  • dose intensification
  • comparison of two dosing regimens
  • Glioblastoma

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