Clinical trial NCT00209989: Phase II Trial to Assess the Radiosensitizing Effect of ZARNESTRA in Patients With Glioblastoma Multiforme
Official title: Phase I/II Trial to Assess the Radiosensitizing Effect of ZARNESTRA in Patients With Glioblastoma Multiforme
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glioblastoma Multiforme
Keywords: Glioblastoma Multiforme
Zarnestra
Radiation therapy
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
Collaborators: name: Janssen-Cilag Ltd.
First posted: 2005-09-21
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: time of study
Secondary outcomes:
measure: Objective response rate (RECIST and volumetric criteria)
timeFrame: time of study
measure: Median survival, 6 month and 1 year survival rates
timeFrame: 6 month and 1 year
measure: Safety of combination therapy of ZARNESTRA and RT, based on laboratory and clinical parameters
timeFrame: time of study
Other outcomes:
Locations:
city: Clermont Ferrand
country: France
facility: Centre Jean Perrin
city: Toulouse
country: France
facility: Institut Claudius Regaud
Study officials:
affiliation: Institut Claudius Regaud
name: Elizabeth MOYAL, Dr
role: PRINCIPAL_INVESTIGATOR
References: