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

Glioblastoma Multiforme Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00209989
• Other study ID #: 02 TETE 02
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: November 23, 2011
• Start date: October 2005
• Est. completion date: June 2011

Study information

• Verified date: November 2011
• Source: Institut Claudius Regaud
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glioblastoma
• Glioblastoma Multiforme

Intervention

Drug:
• Zarnestra
ZARNESTRA 100 bid (phase II recommended dose defined in phase I)will be administered continuously from one week prior to start of radiation therapy until the last day of radiation therapy.

Procedure:
• standard Radiation therapy
Radiotherapy will be focused on the initial tumour volume with a reasonable margin of safety (2 cm). A total dose of 60 Gray (Gy) will be given to the Clinical Target Volume

Locations

Country	Name	City	State
France	Centre Jean Perrin	Clermont Ferrand
France	Institut Claudius Regaud	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
Institut Claudius Regaud	Janssen-Cilag Ltd.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Objective response rate (RECIST and volumetric criteria)		time of study	No
Secondary	Median survival, 6 month and 1 year survival rates		6 month and 1 year	No
Secondary	Safety of combination therapy of ZARNESTRA and RT, based on laboratory and clinical parameters		time of study	Yes