Study With Nelfinavir and Combined Radiochemotherapy for Glioblastoma

NCT00694837 | Completed Phase 1 DMC

• 2 other identifiers: 07-09-04/07EudraCT number 2008-001078-34
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of the trial are: To assess safety, tolerability and activity of nelfinavir given neo-adjuvant and concomitant to chemoradiotherapy with temozolomide in patients with a newly diagnosed glioblastoma multiforme. To describe the possible effect of nelfinavir on functional imaging To describe the activity of nelfinavir in vivo on blocking the AKT pathway.

Conditions

Glioblastoma

Keywords

glioblastoma; nelfinavir; functional imaging; AKT pathway

Outcome Measures

Primary Outcomes (1)

• 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

  Fase 1: after treatment; fase 2: 6 months after treatment

Secondary Outcomes (1)

• 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.

  fase 1: 6 months after treatment; fase 2: 12 months after treatment

Study Arms (1)

B

EXPERIMENTAL

Drug: nelfinavir

Interventions

nelfinavir DRUG

The start dose of nelfinavir in phase 1 is 1000mg BID. The maximum administered dose, if no DLT occurs, will be1250 mg BID (2500mg). Nelfinavir will be administered 1 week before start of the chemoradiotherapy until the last day of chemoradiotherapy.

B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• The opposite from above

Sponsors & Collaborators

• Maastricht Radiation Oncology: lead
• Maastricht University Medical Center: collaborator

Study Sites (1)

Maastricht Radiation Oncology

Maastricht, 6202 AZ, Netherlands

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

Nelfinavir

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Brigitta Baumert, MD PhD

  Maastricht Radiation Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2008
• First Posted: June 11, 2008
• Study Start: March 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: April 10, 2015

Record last verified: 2015-04

Locations

NL (1)