LUTETIUM (177LU) ZADAVOTIDE GURAXETAN for Recurrent grade 3 and grade 4 glioma

Inclusion criteria

• {"criterion_text":"- A previous diagnosis of histologically confirmed WHO grade 3 or grade 4 glioma\n- Radiologically (MRI) confirmed tumor relapse/progression ≥ 12 weeks since completed radiotherapy or suspicion of recurrence where inclusion in the theranostic part of study could be indicated\n- Must be ≥ 18 years old\n- Written informed consent for study participation\n- Negative pregnancy test no longer than 14 days prior to enrollment\n- Life expectancy > 12 weeks\n- Karnofsky performance status ≥ 70% (must be able to care for self after radionuclide therapy)\n- High tumor uptake on diagnostic imaging with 68Ga -PSMA\n- Tumor not amendable for radiotherapy or surgery, and treating oncologist think that there are no other preferable systemic therapy options (e.g temozolomide, PCV or lomustine monotherapy)\n- Women of childbearing potential (WOCBP) defined as fertile, following menarche and until becoming post-menopausal unless permanently sterile must use adequate contraception. Permanent sterilization methods include hysterectomy, bilateral salpingectomy or bilateral oophorectomy.\n- Patient accept not to receive any other tumor directed treatment during a treatment cycle (6-8 weeks)"}

Exclusion criteria

• {"criterion_text":"- Estimated GFR < 30 mL/min\n- Platelet count <75 x109 /L\n- White blood cells ≤ 2.0 x 109/L\n- Neutrophil count < 1.5 x109 /L\n- Hb < 10.0 g/dL\n- Albumin ≤ 30 g/L\n- Uncontrollable symptomatic epilepsy refractory to standard medication\n- Pacemakers or defibrillators not compatible with 3T MRI\n- No ability to obtain informed consent (e.g. due to severe dysphasia or cognitive deficits)\n- Breastfeeding\n- Pregnancy\n- Hypersensitivity to the active substance or to any of the excipients\n- Urinary and fecal incontinence (patient cannot have diaper needs)\n- Significant medical or psychiatric illness that, in the investigator's opinion, would compromise the patient's ability to tolerate this therapy\n- If previous radiotherapy and/or radionuclide therapy have resulted in absorbed doses >=23 Gy to any of the kidneys, or >= 25 Gy to any of the parotids, an individual assessment will be made by the nuclear medicine physician and medical physicist if patient can be included to the therapy part of the study\n- Concurrent investigational drugs or experimental therapy must be stopped at least 4 weeks prior to study entry\n- Unwilling to accept potential challenge with xerostomia"}

Primary endpoints

• {"endpoint_text":"- Evaluation of safety and tolerability: o\tType, frequency and severity of adverse events assessed with the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Attachment 1) and change in score in the modified RAI-6 questionnaire (Attachment 2).","definition_or_measurement_approach":"Type, frequency and severity of adverse events assessed with CTCAE v5.0; change in score in the modified RAI-6 questionnaire."}
• {"endpoint_text":"- Evaluation of efficacy of 177Lu- PSMA: Progression free survival (6 months) and overall survival (1 year) determined from date of commencement of 177Lu-PSMA therapy","definition_or_measurement_approach":"Progression-free survival at 6 months and overall survival at 1 year, determined from date of commencement of 177Lu-PSMA therapy."}

Secondary endpoints

• {"endpoint_text":"- Evaluate radiation dose to tumor and critical organs: Calculation of absorbed doses to the tumor and kidneys, parotid glands, sublingual glands, submandibular glands, lacrimal glands, liver, spleen and red marrow for each therapy cycle as well as accumulated doses for all therapy cycles.","definition_or_measurement_approach":"Calculation of absorbed doses to listed organs for each therapy cycle and accumulated doses across cycles."}
• {"endpoint_text":"- Evaluate efficacy and side effects of treatment on the following from baseline to end of each treatment cycle and to the follow up examinations: o\tTumor responses as assessed by contrast enhanced MRI according to response assessment in neuro oncology (RANO) criteria and volume measurements. o\tNeurologic exam (nano score) o\tHealth-related quality of life EQ-5D scores o\tKarnofsky performance status","definition_or_measurement_approach":"Tumor response assessed by contrast-enhanced MRI per RANO and volume measurements; neurologic exam (nano score); EQ-5D scores; Karnofsky performance status measured from baseline through each cycle and follow-up."}
• {"endpoint_text":"- Evaluate diagnostic and theranostic properties of 68Ga-PSMA","definition_or_measurement_approach":"Not specified in provided data."}

Norway

Earliest CTIS Part Ii Submission Date

27-09-2024

Latest Decision Or Authorization Date

11-02-2025

Processing Time Days

137

Number Of Sites

1

Number Of Participants

10

Primary sponsor

Full Name

Norwegian University Of Science And Technolology

Organisation Type

Educational Institution

Country Of Registered Address

Norway

Third parties

• {"country":"","full_name":"Trond Mohn Foundation","duties_or_roles":"Source of monetary support","organisation_type":""}