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

NCT06477939 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 2020-0082024-515666-13-00
• Study Type: interventional
• Target: 554
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

Brain tumors; Hypoxia; Liposomal transcrocetin

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Overall Survival (OS) is defined as the length of time from the date of tumor resection surgery or definitive biopsy to the date of death.

  Up to 24 months

Secondary Outcomes (6)

• Progression-Free Survival (PFS)

  Up to 24 months

• Evaluation of hypoxia markers

  Up to 24 months

• Quality of life

  Up to 24 months

• Quality of life (GBM module)

  Up to 24 months

• Quality of life (specific for elderly population)

  Up to 24 months

Study Arms (2)

Radiotherapy plus Temozolomide

ACTIVE COMPARATOR

Drug: Administration of L-TC

Administration of L-TC on top of Radiotherapy plus Temozolomide

EXPERIMENTAL

Other: Radiotherapy plus Temozolomide

Interventions

Administration of L-TC DRUG

Administration of L-TC (300 mg) as an IV perfusion, before each radiotion session Radiotherapy : delivered at 40.5 Gy in 15 fractions of 2.7 Gy - One fraction a day 5 fractions per week \+ Temozolomide delivered 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, but for no longer than 25 days.

Radiotherapy plus Temozolomide

Radiotherapy plus Temozolomide OTHER

Radiotherapy : delivered at 40.5 Gy in 15 fractions of 2.7 Gy - One fraction a day 5 fractions per week \+ Temozolomide delivered 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, but for no longer than 25 days.

Administration of L-TC on top of Radiotherapy plus Temozolomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Institut de cancérologie Strasbourg Europe: lead
• LEAF4Life, Inc.: collaborator

Study Sites (1)

Institut de cancérologie Strasbourg Europe

Strasbourg, 67033, France

Location

MeSH Terms

Conditions

Glioblastoma; Brain Neoplasms; Hypoxia

Interventions

Radiotherapy; Temozolomide

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Georges NOEL, MD, PhD

  Institut de cancérologie Strasbourg Europe

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manon VOEGELIN

CONTACT

368767360; promotion-rc@icans.eu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: June 27, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2032
• Study Completion (Estimated): December 31, 2032
• Last Updated: June 27, 2024

Record last verified: 2024-06

Locations

FR (1)