Phase III trial of lomustine/temozolomide (TMZ) combination therapy vs. standard TMZ therapy for newly diagnosed MGMT promoter methylated glioblastoma (IDHwt) patients +/- tumor treating fields (Optune)

Phase 1

• Conditions: Glioblastoma; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-506998-35-00
• Lead Sponsor: Vaestra Goetalandsregionen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-12
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

Written informed consent, Adequate organ function as described in the protocol, Patients on anticoagulation can be included at the discretion of the investigator, but oral anticoagulants, including NOAC/DOAC are recommended to be switched to Low-molecular-weight heparin (LMWH) during the treatment phase and until platelets are >50 or according to local guidelines., Patient capable of understanding the rationale and necessity of study therapy and procedures., Newly diagnosed histologically proven GBM, giant-cell GBM or gliosarcoma WHO Grad 4, histology confirmed by the local neuropathologist as IDHwt. Histology obtained by complete resection, partial resection, open biopsy or stereotactic biopsy., Methylated MGMT promoter in the tumor as determined according to local routine. For centers using the same method/kit the same cut-off for mMGMT will be used., Males or females 18-75 years of age, estimated life expectancy of at least 12 weeks, WHO Performance Score 0-2, Patient compliance and geographic proximity that allow adequate follow up, Male and female patients with reproductive potential must use an approved contraceptive method (intrauterine device, birth control pills, or barrier device) during and for 6 months after end of chemotherapy (Pearl index <1%), Pre-menopausal female patients with childbearing potential: a negative serum pregnancy test must be obtained within 14 days prior to treatment start

Exclusion Criteria

Prior malignancy (except adequately treated carcinoma in situ of the cervix or non-melanoma skin cancer), unless the prior malignancy was diagnosed and curatively treated =3 years previously with no subsquent evidence of recurrence, Any active infection (at the discretion of the investigator), Female patients that are breastfeeding and not willing to refrain, Patients with reproductive potential who do not accept to use contraception during chemotherapy and 6 months thereafter, Treatment in another clinical trial with oncological therapeutic intervention or use of any other investigational agent within 30 days before enrolment, Any psychological, cognitive, familial, social or geographical condition potentially hampering compliance with the study protocol and follow-up scheduled visits (at the discretion of investigator), Prior systemic chemotherapy with DNA-damaging agents for any cancer, Prior RT to the brain, Concurrent administration of any other antitumor therapy not described in the protocol, Concurrent administration of complementary or alternative drugs, Allergy or intolerability of temozolomide, dacarbazine, lomustine or other nitrosourea derivatives including celiac disease and wheat allergy, Unable to perform MRI, Past medical history of diseases with poor prognosis, e.g. severe coronary heart disease, heart failure (NYHA III/IV), severe and poorly controlled diabetes, immune deficiency, residual deficits after stroke or other serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator), Severly reduced lung function (at the discretion of the investigator)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified