Study With Nelfinavir and Combined Radiochemotherapy for Glioblastoma

• Register: ClinicalTrials.gov
• Last refreshed on: 28 January 2013
• Main ID: NCT00694837
• Date of registration: 09/06/2008
• Primary sponsor: Maastricht Radiation Oncology
• Public title: Study With Nelfinavir and Combined Radiochemotherapy for Glioblastoma
• Scientific title: Phase I/II Study for Patients With Newly Diagnosed Glioblastoma Testing Nelfinavir in Combination With Concomitant Temozolomide and Radiotherapy.
• Date of first enrolment: March 2009
• Target sample size: 6
• Recruitment status: Suspended
• URL: http://clinicaltrials.gov/show/NCT00694837
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Netherlands

Contacts

• Name: Brigitta Baumert, MD PhD
• Affiliation: Maastricht Radiation Oncology

Key inclusion & exclusion criteria

Inclusion Criteria:

- Histologically confirmed glioblastoma multiforme at primary diagnosis

- Tumours which do enhance on pre-operative imaging

- Age >=18-65 years

- WHO performance status 0-2, RTOG- RPA class III-IV.

- No recent (< 3 months) severe cardiac disease (arrhythmia, congestive heart failure,
infarction)

- Patient able to tolerate full course of radiotherapy

- No previous radiotherapy to the head and neck area.

- Prior neurosurgery within 6 weeks of treatment

- No previous irradiation of the brain.

- No previous chemotherapy

- No prior or concurrent medical condition which would make treatment difficult to
complete. Medication with steroids is allowed.

- No use of terfenadine, astemizol, cisapride, sildenafil, lovastatin or simvastatin
and other concurrent medication that is metabolized by the CYP3A4 isoenzyme and
cannot be replaced with other equivalent medications for the period of the study:
antiarrhythmics (amiodarone, quinidine), neuroleptics (pimozide), sedative/hypnotic
agents (midazolam, triazolam), ergot derivatives (dihydroergotamine, ergonovine,
ergotamine, methylergonovine), HMG-CoA reductase inhibitors (atorvastatin), rifampin,
rifabutin, felodipine, nifedipine, and sildenafil or St. John's wort.

- Adequate haematological, renal and hepatic function

- No uncontrolled infectious disease, absence of known HIV infection, chronic hepatitis
B or hepatitis C infection

- Absence of any medical condition, which could interfere with oral medication intake
(e.g., frequent vomiting, partial bowel obstruction)

- All patients of reproductive potential (male and female) must use effective
contraception for the whole duration of the treatment and until 6 months thereafter.
Females must not be pregnant or lactating

- Willing and able to comply with the study prescriptions

- Written informed consent before patient registration

Exclusion Criteria:

The opposite from above



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Glioblastoma

Intervention(s)

Drug: nelfinavir

Primary Outcome(s)

Fase I: To determine the MTD of nelfinavir as an adjuvant in the radiochemotherapy treatment in primary glioblastoma patients. Fase 2: Progression free survival at 6 months [Time Frame: Fase 1: after treatment; fase 2: 6 months after treatment]

Secondary Outcome(s)

Fase 1/2: Incidence of acute toxicity; OS; Metabolic ratios of SUV of serial 18F-FDG: assessed by PET-CT.Fase 1:6-months PFS; Relative blood flow measurement by perfusion MRI. Fase 2: PFS at 12 months; Phosphorylation of AKT in tumour tissue. [Time Frame: fase 1: 6 months after treatment; fase 2: 12 months after treatment]

Secondary ID(s)

07-09-04/07

EudraCT number 2008-001078-34

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Maastricht University Medical Center