AGuIX Nanoparticles With Radiotherapy Plus Concomitant Temozolomide in the Treatment of Newly Diagnosed Glioblastoma

Study Purpose

This is a phase I/II clinical trial evaluating the association of AGuIX nanoparticles with radiotherapy plus concomitant Temozolomide in the treatment of newly diagnosed glioblastoma. The primary objectives of this study were to determine the recommended dose of AGuIX in combination with radiotherapy and TMZ during the concomitant radiochemotherapy period (phase I) and to estimate the efficacy of the combination radiochemotherapy + AGuIX (recommended dose), measured by the 6-month progression-free survival rate (PFS) (phase II) Three dose levels of intravenous AGuIX nanoparticles will be explored: 50 mg/kg, 75 mg/kg and 100 mg/kg.

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 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Histological diagnosis of grade IV glioblastoma (biopsy or partial surgery) - Patient not operated or partial resection.
  • - KPS ≥ 70% - Age ≥ 18 years old and <75 years old.
  • - Life expectancy ≥ 6 months.
  • - Platelets ≥ 100,000 / mm3.
  • - PNN ≥ 2000 / mm3.
  • - Hb ≥ 10 g / dL.
  • - Creatinine <1.5 times the upper normal limit or clearance according to Cockcroft-Gault ≥ 50 mL / min.
  • - Liver function (GGT, PAL, ASAT, ALAT, bilirubin) <1.5 times the upper normal limit.
  • - For patients receiving treatment with corticosteroids, treatment with corticosteroids must be at a stable or decreasing dose for at least 14 days before inclusion.
  • - Patient able to swallow and retain oral medication.
  • - Negative serum pregnancy test within 7 days before the first administration of treatment for women.
  • - Women of childbearing potential and men whose partners are of childbearing potential must agree to use, themselves or their partners, an approved method of contraception throughout the treatment and at least 6 months after the last administration of study treatment.
  • - Obtaining signed informed consent from the patient.
  • - Patient affiliated to a social security regimen.

Exclusion Criteria:

  • - prior brain radiotherapy.
  • - prior chemotherapy (including implants containing carmustine (Gliadel®) or immunotherapy (vaccination included) - Any contraindication to TMZ listed in the SPCs.
  • - History of major intestinal resection which may modify the absorption of oral drugs according to the judgment of the investigator.
  • - Diagnosed inflammatory bowel disease (Crohn's disease or ulcerative colitis) - Diarrhea ≥ grade 2 CTCAE (whatever the cause) - Current or recent treatment with another investigational drug or participation in another therapeutic clinical trial (within 30 days of inclusion).
  • - History of other cancer in the 5 years preceding inclusion, except for basal cell carcinomas of the skin and in situ carcinomas of the cervix.
  • - Pregnant or breastfeeding women.
  • - Contraindication to MRI or gadolinium injection.
  • - History of severe anaphylactic reactions due to the injection of gadolinium-based contrast product (dotarem, etc.) - Patient under guardianship or curatorship.
  • - History of nephropathy.
- Psychological disorder or social or geographic reasons that may compromise medical monitoring of the trial or compliance with treatment

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.

NCT04881032
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 1/Phase 2
Lead Sponsor

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

Centre Jean Perrin
Principal Investigator

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

Juliette Moreau, Md
Principal Investigator Affiliation Centre Jean Perrin
Agency Class

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

Other
Overall Status Recruiting
Countries France
Conditions

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

Glioblastoma
Arms & Interventions

Arms

Experimental: AGuIX + chemoradiotherapy (radiotherapy + temozolomide)

addition of AGuIX nanoparticles to standard radiotherapy and concomitant treatment by temozolomide (TMZ) for patients of phase I and patients randomized in experimental arm of phase II

Sham Comparator: chemoradiotherapy (radiotherapy + temozolomide)

standard of care : chemoradiotherapy (radiotherapy + temozolomide) for patients randomized in control arm of phase II

Interventions

Drug: - Polysiloxane Gd-Chelates based nanoparticles (AGuIX)

Four intravenous injections of AGuIX will be delivered. Phase I : Three dose levels may be explored 50 mg/kg, 75 mg/kg and 100 mg/ kg. Phase II : recommended dose

Radiation: - radiotherapy

60 Gy in 6 weeks

Drug: - Temozolomide

Concomitant chemotherapy consists of temozolomide (TMZ) at a dose of 75 mg per square meter per day, given 7 days per week from the first day of radiotherapy until the last day of radiotherapy. After a 4 week break after concomitant treatment, patient were then received up to 6 cycles of adjuvant TMZ according to the standard 5-day schedule every 28 days .

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

CHU de Brest, Brest, France

Status

Not yet recruiting

Address

CHU de Brest

Brest, ,

Centre Jean Perrin, Clermont-Ferrand, France

Status

Recruiting

Address

Centre Jean Perrin

Clermont-Ferrand, , 63011

CHU de Grenoble, Grenoble, France

Status

Not yet recruiting

Address

CHU de Grenoble

Grenoble, ,

Centre Léon Berard, Lyon, France

Status

Not yet recruiting

Address

Centre Léon Berard

Lyon, ,

Institut de Cancérologie de l'Ouest, Saint Herblain, France

Status

Not yet recruiting

Address

Institut de Cancérologie de l'Ouest

Saint Herblain, ,

Strasbourg, France

Status

Not yet recruiting

Address

Institut de Cancérologie Strasbourg Europe

Strasbourg, ,

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