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

• Sponsor: Institut Claudius Regaud (Other)
• Overall Status: Completed
• CT.gov ID: NCT00209989
• Collaborator: Janssen-Cilag Ltd. (Industry)
• Enrollment: 27
• Locations: 2
• Duration (Months): 68
• Patients Per Site: 13.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glioblastoma Multiforme	Drug: Zarnestra; Procedure: standard Radiation therapy	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 27 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase I/II Trial to Assess the Radiosensitizing Effect of ZARNESTRA in Patients With Glioblastoma Multiforme
• Study Start Date: Oct 1, 2005
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Outcome Measures

Primary Outcome Measures

1. 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

1. Objective response rate (RECIST and volumetric criteria) [time of study]

2. Median survival, 6 month and 1 year survival rates [6 month and 1 year]

3. Safety of combination therapy of ZARNESTRA and RT, based on laboratory and clinical parameters [time of study]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 (1.5109/l) Platelet count <100,000/mm3 (100109/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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Jean Perrin	Clermont Ferrand		France
2	Institut Claudius Regaud	Toulouse		France

Sponsors and Collaborators

• Institut Claudius Regaud
• Janssen-Cilag Ltd.

Investigators

• Principal Investigator: Elizabeth MOYAL, Dr, Institut Claudius Regaud

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institut Claudius Regaud
• ClinicalTrials.gov Identifier: NCT00209989
• Other Study ID Numbers: 02 TETE 02
• First Posted: Sep 21, 2005
• Last Update Posted: Nov 24, 2011
• Last Verified: Nov 1, 2011

• Keywords provided by Institut Claudius Regaud: Glioblastoma Multiforme; Zarnestra; Radiation therapy
• Additional relevant MeSH terms: Glioblastoma; Tipifarnib

Study Results

No Results Posted as of Nov 24, 2011