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

NCT00209989 | Completed Phase 2

• 1 other identifier: 02 TETE 02
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

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.

Conditions

Glioblastoma Multiforme

Keywords

Glioblastoma Multiforme; Zarnestra; Radiation therapy

Outcome Measures

Primary Outcomes (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 Outcomes (3)

• 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

Interventions

Zarnestra DRUG

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.

standard Radiation therapy PROCEDURE

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

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Claudius Regaud: lead
• Janssen-Cilag Ltd.: collaborator

Study Sites (2)

Centre Jean Perrin

Clermont-Ferrand, France

Location

Institut Claudius Regaud

Toulouse, France

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

tipifarnib

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

Study Officials

• Elizabeth MOYAL, Dr

  Institut Claudius Regaud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: October 1, 2005
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: November 24, 2011

Record last verified: 2011-11

Locations

FR (2)