Temozolomide in Elderly Patients With KPS < 70 (TAG)

Phase II Trial of Temozolomide in Elderly Patients With Glioblastoma and Poor Performance Status (KPS<70).

The management of glioblastoma in elderly patients with poor performance status (KPS<70) is unsettled. This single arm phase 2 trial trial was designed to evaluate the efficacy and safety of temozolomide alone in this population

Study Overview

• Status: Completed
• Conditions: Glioblastoma; Primary Brain Tumor
• Intervention / Treatment: Drug: Temozolomide

Detailed Description

This trial was conducted to evaluate the efficacy, in terms of survival and quality of life, and safety of up-front temozolomide in elderly GBM patients with poor performance status.

Patients of 70 years of age or older were eligible to participate in this prospective non-randomised multicentric phase II study if they had newly diagnosed and histologically proven glioblastoma on the basis of the WHO classification, and a postoperative KPS between 30 and 60.

Treatment consisted of temozolomide 150-200 mg/m2/day for 5 consecutive days every 4 weeks for a maximum of 12 cycles or until disease progression or prohibited toxicity.

Patients were assessed at least every month by means of physical and neurological examinations, KPS, health-related EORTC questionnaires (QLQ-C30 and QLQ-BN20), and MMSE. Complete blood counts and blood chemistry were drawn before each temozolomide cycle; the earlier were also checked every 10 days during the first 2 cycles and every 2 weeks afterwards. CT or MRI studies were repeated every 2 months.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Pitié Salpêtrière hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Histologically confirmed supratentorial glioblastoma
• Baseline contrast-enhanced CT or gadolinium-enhanced MRI study performed within the first 4 days from resection or within the first 4 weeks from diagnostic biopsy
• Patients aged 70 years or older
• KPS above 30 and below 70
• Life expectancy higher than 4 weeks
• Clinical examination at baseline
• Affiliation to Social Security or mandatory beneficiary
• Patient being informed and obtention of written informed consent

Exclusion Criteria:

• Prior surgical resection dated more than 1 month before inclusion
• Prior brain radiotherapy or chemotherapy
• Severe underlying disease which could interfere with survival
• History of hypersensibility reaction on temozolomide components
• Severe bone marrow hypoplasia
• Aspartate aminotransferase or alanine aminotransferase more than 3 times the upper limit of normal
• Absolute neutrophil count < 1.5x109 cells per liter
• Platelet count < 100x109 cells per liter
• Hemoglobin < 9 g/dl
• Neuroimaging baseline examination performed beyond the first 4 days from resection or beyond the first 4 weeks from diagnostic biopsy

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: temozolomide; Administration of temozolomide 150-200 mg/m2/day for 5 consecutive days every 4 weeks for a maximum of 12 cycles or until disease progression or prohibited toxicity	Drug: Temozolomide; orally 150-200 mg/m2/day for 5 consecutive days every 4 week; Other Names: Temodar, Temodal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall survival	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival		12 months
adverse events	term, grade, frequency	12 months
Health-related quality of life	KPS and EORTC questionnaires (QLQ-C30 and QLQ-BN20)	12 months
Cognitive functioning	characterized by MMSE	12 months
Efficacy according to MGMT Promoter methylation status		12 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Association de Neuro-Oncologues d'Expression Francaise
• Investigators: Principal Investigator: DELATTRE Jean-Yves, MD, PhD, Assistance Publique - Hopitaux de Paris

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: November 16, 2010
• First Submitted That Met QC Criteria: November 16, 2010
• First Posted (Estimate): November 17, 2010

Study Record Updates

• Last Update Posted (Estimate): November 17, 2010
• Last Update Submitted That Met QC Criteria: November 16, 2010
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: Elderly; Temozolomide; Glioblastoma; Karnofsky performance score (KPS)
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Glioblastoma; Brain Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Temozolomide
• Other Study ID Numbers: P060102