Study of Adding or Not Liposomal Transcrocetin (L-TC) With Concomitant HypoFractionated Radiation ThErapy and TEmozolomide in Newly Diagnosed GLioblastoma (GBM) Patients

Korábbi kezelés

• Any previous radiotherapy (RT) of the brain whatever the interval between previous brain RT and diagnoses of GBM)
• Any previous treatment of the GBM (except surgery) such as chemotherapy (including Gliadel wafer or gliasite application), immunotherapy, therapy with a biologic agent, hormonal therapy or Carmustine implant for brain tumors or immunotherapy, including vaccination (whatever the interval between previous treatment and diagnoses of GBM). Glucocorticoid therapy is allowed.
• Previous digestive disease with mis-absorption such as Crohn disease or chronic colitis
• Inclusion in another trial in the 30 previous days
• Serious concurrent infection or medical illness that would jeopardize the ability of the patient to receive study treatment with reasonable safety.
• Contraindication of temozolomide as described in the Summary of product characteristics.

Más betegség

• Patient has a known hypersensitivity to crocetins, L-TC or any of its excipients.

Életkor

• Patients with previous cancer (< 5 years) except basocellular skin tumors and in situ cervix tumor

Egyéb

• For both cohorts
• Ongoing diarrhea grade ≥ 2 in the NCI CTCAE V5.0 (whatever the cause)
• Patient who cannot undergo MRI
• Pregnant or lactating woman.
• Patient who cannot understand French language.
• Patient without French National Health insurance
• Patient who cannot be reliable for follow-up
• Patient under law protection

• Cohort 1 - Non-operable patients
  • Patients aged at least 18 years old and ≤ 70 years old; male or female.
  • AND available biopsy
  • AND Karnofsky index ≥ 50% at Screening
• Cohort 2 - Elderly patients
  • Patients aged > 70 years old; male or female
  • AND Balducci score I or II. For patients classified in Balducci II, only light Balducci II will be included, as defined by a Charlson score <4 and a score of autonomy IADL = 4. In the oncogeriatric evaluation, symptoms related to brain cancer disease have not to be considered for this criterion.
  • Karnofsky score (KPS) of ≥ 70% at Screening
  • Regardless resection
  • MRI at maximum 48h00 after surgery if partial, subtotal or macroscopically complete or supra-total resection
• For both cohorts
  • Histologically confirmed diagnosis of glioblastoma (GBM) (2016 OMS classification) (Louis et al., 2016).
  • Contrast enhancing disease on MRI within 14 days prior to screening.
  • Within 2 weeks of baseline visit, hematologic and renal functions as specified: Absolute neutrophil count ≥ 1500/mm3, platelets ≥ 100,000/mm3, Hgb ≥ 9.0g/dL, creatinine ≤ 1.7mg/dl, total bilirubin ≤ 1.5mg/dL, blood urea nitrogen (BUN) within 2 times the upper limit of normal, transaminases ≤ 4 times above the upper limits of the institutional norm.
  • Sexually active patients must use an acceptable method of contraception while receiving doses of study medication.
  • Females of childbearing potential must have a negative serum or urine pregnancy test at screening and have additional pregnancy tests during study.