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New treatment option for Oligodendroglioma
Official title A Clinical Study to Improve Brain Function and Quality of Life of Patients With Newly Diagnosed Brain Tumors (Gliomas).
ClinicalTrials.gov ID: NCT05331521
What this study is testing
What is CETEG?
CETEG is an investigational medicine, given as an once-weekly, being studied as a potential treatment for oligodendroglioma.
Also referred to as Lomustine (CCNU) and Temozolomide.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Oligodendrogliomas in the novel edition of the Central Nervous System (CNS) World Health Organization (WHO) classification are now molecularly defined by isocitrate dehydrogenase (IDH)1 or IDH2 mutations and 1p/19q co-deletion. The prognosis of these molecularly defined tumors is to be determined in new series since survival data from older histology-based studies and population-based registries are confounded by the inclusion of 20-70% not molecularly matching subsets.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically confirmed, newly diagnosed CNS WHO grade 2 or 3 glioma.
- Tumor carries an isocitrate dehydrogenase (IDH) mutation (determined by immunohistochemistry (IHC) and/or deoxyribonucleic acid (DNA) sequencing).
- Tumor is co-deleted for 1p/19q (determined by copy number variations, fluorescence in situ hybridization (FISH), multiplex ligation-dependent probe...
- Biopsy (with sufficient tissue for molecular pathology) or resection.
- Age: ≥18 years.
You likely can't join if
- Participation in other ongoing treatment clinical trials.
- Inability to undergo MRI.
- Abnormal (≥ Grade 2 CTCAE v5.0 laboratory values for hematology (Hb, WBC, neutrophils, or platelets), liver (serum bilirubin, ALT, or AST) or renal...
- Clinically active tuberculosis; known HIV infection or active Hepatitis B (HBV) or Hepatitis C (HCV) infection, or active infections requiring oral...
- Any prior anti-cancer therapy or co-administration of anti-cancer therapies other than those administered/allowed in this study. History of low-grade...
- Immunosuppression, not related to prior treatment for malignancy.
See the full eligibility criteria
- Histologically confirmed, newly diagnosed CNS WHO grade 2 or 3 glioma.
- Tumor carries an isocitrate dehydrogenase (IDH) mutation (determined by immunohistochemistry (IHC) and/or deoxyribonucleic acid (DNA) sequencing).
- Tumor is co-deleted for 1p/19q (determined by copy number variations, fluorescence in situ hybridization (FISH), multiplex ligation-dependent probe amplification (MLPA) or other appropriate methods).
- Biopsy (with sufficient tissue for molecular pathology) or resection.
- Age: ≥18 years.
- Karnofsky Performance status (KPI) ≥60%.
- Life expectancy \>6 months.
- Availability of formalin-fixed paraffin-embedded (FFPE) or fresh-frozen tissue and ethylenediamine tetraacetic acid (EDTA) blood for biomarker research.
- Standard magnetic resonance imaging (MRI) ≤ 72 h post-surgery according to the present national and international guidelines.
- Craniotomy or intracranial biopsy site must be adequately healed.
- ≥ 2 weeks and ≤ 3 months from surgery without any interim radio- or chemotherapy or experimental intervention.
- Willing and able to comply with regular neurocognitive and health-related quality of life tests/questionnaires.
- Indication for postsurgical cytostatic/-toxic therapy.
- Written Informed consent.
- Female patients with reproductive potential have a negative pregnancy test (serum or urine) day -6 until day 0 of screening (and 3 days prior to first IMP-intake or RT). Female patients are surgically sterile or agree...
- Male patients are willing to use contraception
- Participation in other ongoing treatment clinical trials.
- Inability to undergo MRI.
- Abnormal (≥ Grade 2 CTCAE v5.0 laboratory values for hematology (Hb, WBC, neutrophils, or platelets), liver (serum bilirubin, ALT, or AST) or renal function (serum creatinine).
- Clinically active tuberculosis; known HIV infection or active Hepatitis B (HBV) or Hepatitis C (HCV) infection, or active infections requiring oral or intravenous antibiotics or that can cause a severe disease and pose...
- Any prior anti-cancer therapy or co-administration of anti-cancer therapies other than those administered/allowed in this study. History of low-grade glioma that did not require prior treatment with chemotherapy or...
- Immunosuppression, not related to prior treatment for malignancy.
- History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 5 years unless the patient has been disease-free for 5 years.
- Any clinically significant concomitant disease (including hereditary fructose intolerance) or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study or the...
- Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; those conditions should be discussed with the...
- Pregnancy or breastfeeding.
- History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product. (E.g...
- QTc time prolongation \>500 ms.
- Patients under restricted medication for procarbazine, lomustine, vincristine and temozolomide.
- Liver disease characterized by:
- ALT or AST (≥ Grade 2 CTCAE v5.0) confirmed on two consecutive measurements OR
- Impaired excretory function (e.g., hyperbilirubinemia) or synthetic function or other conditions of decompensated liver disease such as coagulopathy, hepatic encephalopathy, hypoalbuminemia, ascites, and bleeding from...
- Acute viral or active autoimmune, alcoholic, or other types of acute hepatitis.
- Known uncorrected coagulopathy, platelet disorder, or history of non-drug induced thrombocytopenia.
- History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis...
- Vaccination with life vaccines during treatment and 4 weeks before start of treatment.
- Existing neuromuscular diseases, especially neural muscular atrophy with segmental demyelination (demyelinising form of Charcot-Marie-Tooth syndrome).
- Chronic constipation and subileus.
- Combination treatment with mitomycin (risk of a pronounced bronchospasm and acute shortness of breath).
- Hypersensitivity to dacarbazine (DTIC).
- Patients with hereditary galactose intolerance, complete lactase deficiency or glucose-galactose malabsorption (Temodal contains Lactose).
- Patients with clinical wheat allergy.
The study team makes the final eligibility decision.
Where it's taking place
- Heidelberg, Baden-Wurttemberg, Germany
- Berlin, Germany
- Bochum, Germany
- Bonn, Germany
- Chemnitz, Germany
- Cologne, Germany
- Düsseldorf, Germany
- Frankfurt, Germany
- Göttingen, Germany
- Homburg, Germany
- Jena, Germany
- Leipzig, Germany
- Mannheim, Germany
- Minden, Germany
- Munich, Germany
- Regensburg, Germany
- Schwerin, Germany
- Tübingen, Germany
- Würzburg, Germany
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Heidelberg, Baden-Wurttemberg, Germany; Berlin, Germany; Bochum, Germany; Bonn, Germany; Chemnitz, Germany; Cologne, Germany and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.