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Temozolomide Plus Bevacizumab in Supratentorial Glioblastoma in 70 Years and Older Patients With an Impaired Functional Status

Study Purpose

The optimal treatment of glioblastoma multiforme (GBM) in patients aged ≥70 years with a Karnofsky performance status (KPS) <70 is unestablished. This clinical trial evaluated the efficacy and safety of upfront temozolomide (TMZ) and bevacizumab (Bev) in patients aged ≥70 years and a KPS <70.

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:

  • - Supratentorial Glioblastoma diagnosed by biopsy.
  • - Patients aged ≥ 70 years.
  • - KPS >30 and < 70.
  • - Life expectancy > or = 8 weeks.
  • - Patients were enrolled at least 14 days after stereotactic biopsy and 28 days after surgical biopsy.
  • - CT or brain MRI was performed within 4 weeks before treatment to rule out haemorrhage.
  • - Included to health social security system.
  • - Medical assessment previous to inclusion.
  • - Informed consent form.

Exclusion Criteria:

  • - Previous treatment with Surgical resection, RT or chemotherapy to the tumor.
  • - Hemoglobin level < 9 g% - Absolute neutrophil count < 1500.
  • - Platelet count < 100.000.
  • - ASAT or ALAT levels more than 3 times the upper limit of normal.
  • - Bilirubin levels more than 2 times the upper limit of normal.
  • - Creatinin more than 1.5 times the upper limit of normal.
  • - Untreated high blood pressure >150/100 mmHg.
  • - Congestive cardiac failure.
  • - Proteinuria > 1 gr/24h.
  • - INR > 1.5 the upper limit of normal.
  • - Recent symptomatic haemorrhage.
  • - History of abnormal wound healing.
  • - Gastrointestinal fistula.
  • - Haemoptysis > grade 2 (NCI-CTC) - Intracranial abscess.
  • - Coagulation disorder.
  • - Active infection requiring intravenous antibiotics.
  • - Vascular disease (including myocardial infarction, unstable angina, cerebrovascular disease, peripheral arterial or aortic disease) in the previous 6 months.
  • - Malignancy diagnosed in the previous 5 years (except basocellular skin cancer and in situ cervix cancer) - Allergy to dacarbazine, Bevacizumab, Temozolomide or their excipients, recombinant human monoclonal antibodies, or ovarian cells of Chinese hamsters.

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.

 NCT02898012
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.

 Jean-Yves Delattre, MD-PhD
Principal Investigator Affiliation Pôle MSN, Groupe Hospitalier Pitié-Salpêtrière
Agency Class

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

 Other, Industry
Overall Status Completed
Countries France
Conditions

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

 Glioblastoma Multiforme, Primary Brain Tumor
Additional Details

Elderly patients aged 65 years and older account for approximately 45% of GBM patients, and this figure is expected to rise concurrently with the aging population of most countries. Unfortunately, few trials have been performed in this setting. In elderly patients with good functional status (KPS >70), radiotherapy (RT) prolongs overall survival (OS) without causing a detriment in quality of life compared with palliative care alone. Recently, it was shown that TMZ could be an alternative to RT. In elderly patients with poor functional status at symptom onset (KPS < 70), RT does not appear to be a satisfactory option in this frail population; however, investigators previously found that TMZ alone was associated with improvements in functional status in 1/3 of cases and appeared to increase survival compared with supportive care alone, especially in methylated MGMT promoter patients. Bevacizumab (Bev) is an antiangiogenic monoclonal antibody targeting VEGF (vascular endothelial growth factor) that is currently used in recurrent GBM, particularly in combination with alkylating agents. Its effect as first line treatment in combination with TMZ and RT is controversial. In this study, investigators evaluated the efficacy and safety of the upfront combination of TMZ + Bev as an initial treatment for elderly patients with GBM and impaired functional status (KPS <70).

Arms & Interventions

Arms

Experimental: Temozolomide and Bevacizumab

Single experimental arm with two drugs : Temozolomide and Bevacizumab

Interventions

Drug: - Temozolomide

Temozolomide (TMZ) Temozolomide (TMZ) administered at 130-150 mg/m2 for 5 consecutive days every 4 weeks up to 12 cycles. IV or oral administration was allowed according to the clinical status. TMZ starts at 130 mgs/m2 and increase to 150 mgs/m2 during the second cycle in the absence of hematologic toxicity. In the case of grade 3 or 4 toxicity, the dose for the next cycle is decreased to 110 mg/m2. If the grade 3 or 4 toxicity persists at a dose of 110 mg/m2, treatment is discontinued.

Drug: - Bevacizumab

Bevacizumab (Bev) administered at a dose of 10 mgs/kg every 2 weeks. Bev was interrupted in cases of wound healing disturbances, gastrointestinal perforation, intestinal occlusion, fistula, uncontrolled hypertension, nephrotic syndrome, grade 4 or recurrent grade 3 thromboembolic events, arterial thrombosis, hemorrhage > grade 2, left ventricular failure, or posterior reversible leukoencephalopathy.

Contact a Trial Team

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International Sites

Groupe Hospitalier Pitié-Salpêtrière, Paris, France

Status

Address

Groupe Hospitalier Pitié-Salpêtrière

Paris, , 75013

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