Glioma study: Temozolomide vs 177Lu-PSMA-617
Official title A Study of 177Lu-PSMA-617 in People With Gliomas
ClinicalTrials.gov ID: NCT07223034
What this study is testing
What is Temozolomide?
An investigational oral medication being studied for use in patients with IDH wild type glioma.
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
- This study is testing whether 177Lu-PSMA-617 is safe for people with IDH wild type glioma.
- Who it's for
- You may be able to join if you have one of the listed glioma types and meet the study criteria.
- What's involved
- You would receive the drug and have medical checks to see how your body reacts.
- Time commitment
- The study lasts a few weeks with several visits for treatment and safety monitoring.
- Phase 1: an early, usually small safety 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
- Diffuse astrocytoma, IDH-wildtype (grade 2-4)
- Glioblastoma, IDH-wildtype
- Diffuse midline glioma, H3 K27-altered
- Diffuse hemispheric glioma, H3 G34-mutant
- Diffuse pediatric-type high-grade glioma, H3-wildtype and IDH-wildtype PSMA positive pathological stain (by immunohistochemistry) of baseline...
You likely can't join if
- Patient known to harbor any other non-canonical IDH mutations (i.e., non-R132H)
- Target lesion within 5 mm of either the brainstem, optic chiasm or optic nerves Receipt of bevacizumab as part of the initial treatment for glioma
- Life expectancy less than 12 weeks
- Nonhealing wound, ulcer or bone fracture
- History of severe brain injury
- Patient not eligible for sequential MRI evaluations
See the full eligibility criteria
- Diffuse astrocytoma, IDH-wildtype (grade 2-4)
- Glioblastoma, IDH-wildtype
- Diffuse midline glioma, H3 K27-altered
- Diffuse hemispheric glioma, H3 G34-mutant
- Diffuse pediatric-type high-grade glioma, H3-wildtype and IDH-wildtype PSMA positive pathological stain (by immunohistochemistry) of baseline (pre-radiotherapy) resection or biopsy sample
- Completion of standard of care therapy including surgery (for resectable tumors) and adjuvant EBRT for glioma
- Patients must be on a dose of 4 mg or less of dexamethasone (or dexamethasone equivalent steroid) for 5 days prior to first planned dose of radiopharmaceutical
- Age ≥ 18
- ECOG ≤ 2
- Serum creatinine level \ 60 mL/min
- Liver laboratory values: ALT and AST ≤ 2.5 x ULN; Albumin \> 2 g/ dL; Bilirubin \< 3 X ULN
- Normal organ and marrow function as defined as the following
- Total white blood count \> 3.0 K/mcL
- ANC ≥ 1.5 K/mcL
- Platelets ≥ 100 K/mcL
- Hemoglobin ≥ 9 g/dL
- Adequate contraception prior to registration (see section 9.0)
- Ability to understand, and willingness to sign the informed consent.
- Patient known to harbor any other non-canonical IDH mutations (i.e., non-R132H)
- Target lesion within 5 mm of either the brainstem, optic chiasm or optic nerves Receipt of bevacizumab as part of the initial treatment for glioma
- Life expectancy less than 12 weeks
- Nonhealing wound, ulcer or bone fracture
- History of severe brain injury
- Patient not eligible for sequential MRI evaluations
- Patients with prior RT to \> 25% of the skeleton or prior exposure to prior Radium223, Strontium89 or Samarium153 containing compounds
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works assessment of the investigational regimen
- Unable to tolerate the PSMA PET/MR or PSMA PET/CT
- History of viral hepatitis or chronic liver disease with active symptoms
- History of pituitary or adrenal dysfunction
- Previously diagnosed active infection (e.g., human immunodeficiency virus [HIV] or viral hepatitis)
- Any condition that in the opinion of the investigator, would preclude participation in this study
- Receipt of any other investigational agents or participation in a concurrent treatment protocol
- Known allergies, hypersensitivities, or intolerance to 68Ga-PSMA-11/177Lu-PSMA-617 or its inactive compounding components
- Current or planned pregnancy
- Refusal to comply with detailed contraception requirements
The study team makes the final eligibility decision.
Where it is enrolling
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, but 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?
This study is enrolling now at Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States; New York, New York, United States and 1 more location. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.