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Temozolomide in Elderly Patients With KPS < 70

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 70 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT01242566
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Assistance Publique - Hôpitaux de Paris
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 DELATTRE Jean-Yves, MD, PhD
Principal Investigator Affiliation Assistance Publique - Hôpitaux de Paris
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Completed
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Primary Brain Tumor, Glioblastoma
Additional Details

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.

Arms & Interventions

Arms

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

Interventions

Drug: - Temozolomide

orally 150-200 mg/m2/day for 5 consecutive days every 4 week

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Pitie salpetriere hospital, Paris, France

Status

Address

Pitie salpetriere hospital

Paris, , 75013

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