Phase III Randomized Study of Adding or Not Liposomal Transcrocetin (L-TC) With Concomitant HypoFractionated Radiation ThErapy and TEmozolomide in Newly Diagnosed GLioblastoma (GBM) Patients to Evaluate Efficacy and Safety

Trial ID: NCT06477939

Interventional - Phase 3 - Not yet recruiting

This is phase III randomized, multicenter study adding or not intra-venous Liposomal Trasncrocetin (L-TC) to hypofractionated radiotherapy and concomitant Temozolomide followed by adjuvant Temozolomide in patients with histologically confirmed diagnosis of glioblastoma (GBM).

Conditions

• Glioblastoma

Interventions

• Administration of L-TC
• Radiotherapy plus Temozolomide

Eligibility

Inclusion criteria

• 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.

Exclusion criteria

• For both cohorts
• 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
• Ongoing diarrhea grade ≥ 2 in the NCI CTCAE V5.0 (whatever the cause)
• Inclusion in another trial in the 30 previous days
• Patient who cannot undergo MRI
• Pregnant or lactating woman.
• Serious concurrent infection or medical illness that would jeopardize the ability of the patient to receive study treatment with reasonable safety.
• Patients with previous cancer (\< 5 years) except basocellular skin tumors and in situ cervix tumor
• Patient has a known hypersensitivity to crocetins, L-TC or any of its excipients.
• Contraindication of temozolomide as described in the Summary of product characteristics.
• Patient who cannot understand French language.
• Patient without French National Health insurance
• Patient who cannot be reliable for follow-up
• Patient under law protection

Sponsor

Institut de cancérologie Strasbourg Europe, LEAF4Life, Inc.

Source: ClinicalTrials.gov

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