A Study to Evaluate the Safety and Efficacy of CLZ-3002, Concomitantly Treated with Concurrent Chemoradiation Therapy (CCRT), in Patients Newly diagnosed with Glioblastoma

Not Applicable

Recruiting

• Conditions: Neoplasms

• Registration Number: KCT0009511
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1) Patients who voluntarily decided to participate and gave written consent after hearing about the characteristics of this clinical trial and clinical trial drugs
2) Adults between the ages of 19 and 70
3) As a glioblastoma patient,
? Diagnosed as glioblastoma confined to the supratentorial compartment in imaging diagnosis,
? Glioblastoma (IDH-wild type) confirmed at the time of surgery or by histological examination afterward
4) Those who scored 2 points or less on ECOG
5) Those who are scheduled to undergo radiation and temozolomide combination therapy (CCRT) after tumor removal surgery

Exclusion Criteria

1) Recurrent glioblastoma
2) Leptomeningeal dissemination and other distant metastasis (bone marrow, lung, liver, etc.) glioblastoma
3) When only tumor tissue biopsy was performed
4) Applicants of Gliadel wafer or local brachytherapy
5) Those who cannot perform MRI according to the clinical trial schedule
6) If toxicity of previous treatment has not recovered to baseline level or CTCAE Grade 1 or lower, except for alopecia
7) Past or current medical history of newly diagnosed cardiovascular disease within 3 months prior to participation in this clinical trial that is not controlled by the following
(1) congestive heart failure
(2) myocardial infarction
(3) Unstable angina with new drug administration or dose change within 3 months
(4) Arrhythmias with pacemaker implantation
(5) Transient ischemic attack (TIA) or stroke with neurologic deficits
8) Severe renal impairment (CrCl <30mL/min), renal failure, patients undergoing renal dialysis, etc.)
9) History of severe hepatic impairment (liver cirrhosis) or abnormality in laboratory tests corresponding to the following (retest before administration of ‘human cells, etc.’ is possible)
(1) ALT more than 3 times the upper limit of normal (UNL); More than 5 times in patients with liver metastases
(2) Total bilirubin more than 1.5 times the upper limit of normal (UNL); More than 3 times in case of Gilbert syndrome.
10) Patients with deep vein thrombosis (DVT) or pulmonary embolism (PE) that is not controlled by anticoagulant treatment, etc.
11) Patients with diabetes not controlled by oral hypoglycemic agents or insulin
12) Immunodeficiency requiring immunoglobulin or immunostimulant treatment
13) Past and current history of chronic autoimmune disease (However, type 1 diabetes and hypothyroidism are not applicable.)
14) Abnormalities in the following test values (can be retested until peripheral blood collection)
(1) Hgb<9 g/dL
(2) Absolute neutrophil count (ANC) <1,500 cells/mm³
(3) Platelet count <100,000 cells/mm³
15) A history of malignant tumors that occurred within 3 years other than the indications for this clinical trial. However, thyroid cancer (stage I or II papillary, follicular, medullary types), basal cell or squamous cell carcinoma of the skin, CIN and CIS of the cervix, and intraepithelial carcinoma of other sites are excluded.
16) Patients with the following clinically active infections
(1) Hepatitis B (if confirmed positive in HBsAg test, HBV nucleic acid amplification test)
(2) Hepatitis C (if confirmed positive by HCV antibody test or HCV nucleic acid amplification test)
(3) HIV infection (HIV antibody test, HIV nucleic acid amplification test positive)
(4) Syphilis infection (if non-treponemal test or treponema test positive)
(5) Other active infection or unexplained fever >38.5°C (101.3°F) judged unlikely to participate in the clinical trial.
17) Previous history of hypersensitivity to the ingredients constituting this clinical trial drug (CLZ-3002 active ingredient and excipient)
18) The following contraindications to Temozolomide.
(1) Previous history of hypersensitivity to temozolomide or dacarbazine
(2) galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
19) Diclofenac acid Contraindications
20) Subjects who received contraindicated medicines or treatments before participating in clinical trials and for whom the specified period has not elapsed
21) Patients scheduled to receive concomitantly contraindicat

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified