68Ga/177Lu-PSMA Theranostics in Recurrent Grade 3 and Grade 4 Glioma

Trial ID: NCT05644080

Interventional - Phase Unknown - Completed

This interventional, clinical pilot-study will initiate and evaluate 68Ga/177Lu-PSMA theranostics in Norway as treatment alternative for patients with recurrent grade 3 and grade 4 gliomas. The main goal is to improve existing diagnostic and therapeutic methods in glioma management, and introduce a novel, well-tolerated radionuclide treatment that possibly can increase the overall survival and quality of life for a patient group that today have very short expected survival and no standard recommended therapy.

Conditions

• High Grade Glioma

Interventions

• 177Lu-PSMA I&T

Eligibility

Inclusion criteria

• A previous diagnosis of histologically confirmed WHO grade 3 or grade 4 glioma
• 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
• Must be ≥ 18 years old
• Written informed consent for study participation
• Negative pregnancy test no longer than 14 days prior to enrollment
• Life expectancy \> 12 weeks
• Karnofsky performance status ≥ 70% (must be able to care for self after radionuclide therapy)
• High tumor uptake on diagnostic imaging with 68Ga -PSMA.
• 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).
• 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. Adequate contraception in the current study will be the following:
• o Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
• Intravaginal
• transdermal
• Progestogen-only hormonal contraception associated with inhibition of ovulation:
• oral
• injectable
• implantable
• intrauterine device (IUD)
• intrauterine hormone-releasing system ( IUS)
• bilateral tubal occlusion
• vasectomised partner
• sexual abstinence
• Patient accept not to receive any other tumor directed treatment before 8 weeks after each 177Lu-PSMA injection.

Exclusion criteria

• Estimated GFR \< 30 mL/min
• Platelet count \<75 x109 /L
• White blood cells ≤ 2.5 x 109/L
• Neutrophil count \< 1.5 x109 /L
• Hb \< 8.0 g/dL
• Albumin ≤ 25 g/L
• Uncontrollable symptomatic epilepsy refractory to standard medication
• Pacemakers or defibrillators not compatible with 3T MRI
• No ability to obtain informed consent (e.g. due to severe dysphasia or cognitive deficits).
• Breastfeeding
• Pregnancy
• Hypersensitivity to the active substance or to any of the excipients
• Urinary and fecal incontinence (patient cannot have diaper needs)
• Significant medical or psychiatric illness that, in the investigator's opinion, would compromise the patient's ability to tolerate this therapy
• 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.
• Concurrent investigational drugs or experimental therapy must be stopped at least 4 weeks prior to study entry
• Unwilling to accept potential challenge with xerostomia

Sponsor

St. Olavs Hospital, Norwegian University of Science and Technology

Source: ClinicalTrials.gov

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