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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-07

Study Completion Date

2027-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Glioblastoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Phase 1 : dose escalation Phase 2 : randomized

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Polysiloxane Gd-Chelates based nanoparticles (AGuIX)

Intervention Type DRUG

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

radiotherapy

Intervention Type RADIATION

60 Gy in 6 weeks

Temozolomide

Intervention Type DRUG

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 .

chemoradiotherapy (radiotherapy + temozolomide)

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

Group Type SHAM_COMPARATOR

radiotherapy

Intervention Type RADIATION

60 Gy in 6 weeks

Temozolomide

Intervention Type DRUG

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 .

Interventions

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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

Intervention Type DRUG

radiotherapy

60 Gy in 6 weeks

Intervention Type RADIATION

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 .

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histological diagnosis of grade IV glioblastoma (biopsy or partial surgery)
* Patient not operated or partial resection
* KPS superior to 70%
* Age between 18 years old and 75 years old
* Life expectancy superior to 6 months
* Platelets superior to 100,000 / mm3
* PNN superior to 1500 / mm3
* Hb superior to 10 g / dL
* Creatinine superior to 1.5 times the upper normal limit or clearance according to Cockcroft-Gault superior to 50 mL / min
* Liver function (GGT, PAL, ASAT, ALAT, bilirubin) superior to 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 disease or ulcerative colitis)
* Diarrhea superior to 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No