Phase II Trial to Assess the Radiosensitizing Effect of ZARNESTRA in Patients With Glioblastoma Multiforme

Phase I/II Trial to Assess the Radiosensitizing Effect of ZARNESTRA in Patients With Glioblastoma Multiforme

The purpose of this study is to determine the efficacy by the determination of the Time To Progression (TTP) in patients with resectable GBM or non surgical GBM with a size less than 5 cm treated with the combination of ZARNESTRA plus Radiation therapy.

Study Overview

• Status: Completed
• Conditions: Glioblastoma Multiforme
• Intervention / Treatment: Drug: Zarnestra; Procedure: standard Radiation therapy

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Clermont Ferrand, France
    • Centre Jean Perrin
  • Toulouse, France
    • Institut Claudius Regaud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients must have pathologically confirmed (histology or cytology), resectable or non resectable, glioblastoma multiforme with a size < 5 cm on MRI if non resectable
• Patients must be at least 7 days but no more than 2 months since surgery or biopsy.
• Patients must have an ECOG Performance Status ≤ 2.
• Patients must be aged 18
• Patient has signed the informed consent form

Exclusion Criteria:

• Patients with unresectable glioblastoma with a size >5 cm on MRI
• Patients with clinically apparent leptomeningeal metastases
• Patients with uncontrolled seizures despite standard anticonvulsant therapy
• Any prior systemic treatment (chemotherapy, immunotherapy, hormonal therapy) for glioblastoma multiforme
• Significantly abnormal haematological status as judged by:

Absolute neutrophil count (ANC) < 1500/mm3 (1.5*109/l) Platelet count <100,000/mm3 (100*109/l)

• Serum bilirubin >2 mg/dl (>34 mmol/l) or Transaminase >2.5x the upper limit of institutional normal or Creatinine >1.5 mg/dl (>132 mmol/l)
• Inability to co-operate with the treatment protocol
• Patients who cannot undergo imaging evaluations
• Participation in an investigational drug trial in the 30 days prior to selection
• Pregnant or nursing mothers. (Female patients of childbearing potential must use adequate contraception.)
• Any malignancy within the past five years. Exceptions are: superficial basal cell carcinoma or non-metastatic squamous cell cancer of the skin, cervix cancer (cervical intra-epithelial neoplasia -CIN or FIGO stage 1) or prostate intra-epithelial neoplasia (PIN), biochemical relapse free for at least 3 years.
• Any prior systemic chemotherapy in the past five years for any malignancy in the medical history
• Any concurrent disease that in the opinion of the investigator would constitute a hazard for participating in this study
• Known sensitivity to imidazole derivatives
• Patients under law protection
• Medical history of phlebitis or pulmonary embolism, thrombocytosis, myocardiopathy, or other relevant cardiac pathology (auricular flutter, auricular fibrillation)
• Medical history of immuno-allergic pneumopathy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Efficacy will be assessed by the determination of the Time To Progression (TTP) in patients with resectable GBM or non surgical GBM with a size less than 5 cm treated with the combination of ZARNESTRA plus Radiation therapy	time of study

Secondary Outcome Measures

Outcome Measure	Time Frame
Objective response rate (RECIST and volumetric criteria)	time of study
Median survival, 6 month and 1 year survival rates	6 month and 1 year
Safety of combination therapy of ZARNESTRA and RT, based on laboratory and clinical parameters	time of study

Collaborators and Investigators

• Sponsor: Institut Claudius Regaud
• Collaborators: Janssen-Cilag Ltd.
• Investigators: Principal Investigator: Elizabeth MOYAL, Dr, Institut Claudius Regaud

Study record dates

Study Major Dates

• Study Start: October 1, 2005
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 21, 2005

Study Record Updates

• Last Update Posted (Estimate): November 24, 2011
• Last Update Submitted That Met QC Criteria: November 23, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: Glioblastoma Multiforme; Radiation therapy; Zarnestra
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Antineoplastic Agents; Tipifarnib
• Other Study ID Numbers: 02 TETE 02