177Lu-PSMA-617 for Brain Cancer

Recruiting at 6 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Memorial Sloan Kettering Cancer Center

Must be taking: Dexamethasone

Must not be taking: Bevacizumab

Disqualifiers: Chronic kidney disease, Viral hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called 177Lu-PSMA-617 to determine its safety for individuals with IDH wild type glioma, a type of brain cancer. The treatment uses a special form of radiation therapy and aims to assist patients who have already undergone standard treatments like surgery and chemotherapy. Participants should have a confirmed diagnosis of IDH wild type glioma and have completed other standard therapies. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I need to stop my current medications to join the trial?

The trial requires that you be on a dose of 4 mg or less of dexamethasone (a type of steroid) for 5 days before starting the treatment. Other than this, the protocol does not specify if you need to stop taking your current medications.

Is there any evidence suggesting that 177Lu-PSMA-617 is likely to be safe for humans?

Research has shown that 177Lu-PSMA-617 has been tested in various contexts. One study demonstrated a noticeable decrease in PSMA activity after three treatment cycles, indicating effective targeting of certain cells. Another study found that 15% of patients experienced serious blood-related side effects, though these were manageable and not common for all recipients.

Overall, evidence suggests that 177Lu-PSMA-617 can be effective, but potential side effects should be considered. This treatment remains in the early stages of testing for brain cancer, so its complete safety profile is not yet known. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for brain cancer?

Researchers are excited about 177Lu-PSMA-617 for brain cancer because it introduces a novel approach to treatment by specifically targeting prostate-specific membrane antigen (PSMA), which is often present in brain tumors. Unlike traditional chemotherapy or radiation, which can affect healthy brain tissue, this treatment uses a radioactive compound to directly deliver radiation to cancer cells, potentially reducing side effects. The combination of 177Lu-PSMA-617 with imaging techniques like 68Ga-PSMA-PET scans allows for precise monitoring of the treatment's effectiveness, offering hope for better outcomes in managing brain cancer.

What evidence suggests that 177Lu-PSMA-617 might be an effective treatment for brain cancer?

Research has shown that 177Lu-PSMA-617 holds promise for treating certain cancers. One study found it significantly lowered prostate-specific antigen (PSA) levels in many prostate cancer patients. In this trial, researchers are investigating 177Lu-PSMA-617 for its potential to treat brain tumors by targeting a protein called PSMA, often present in these tumors. Most patients tolerate the treatment well, with side effects that are usually manageable. Although more research is needed for brain cancer, these early results are encouraging. ^{1 3 6 7 8}

Who Is on the Research Team?

Brandon Imber, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with specific brain tumors, including gliomas and glioblastoma. Participants must have a type of tumor that does not contain IDH mutations (IDH wild type). The full eligibility criteria are not provided, so additional requirements or restrictions may apply.

Inclusion Criteria

Liver laboratory values within specified ranges

Adequate contraception prior to registration

I've been taking 4 mg or less of dexamethasone daily for the last 5 days.

Exclusion Criteria

Inability to tolerate specific imaging procedures

History of pituitary or adrenal dysfunction

Any condition deemed by the investigator to preclude study participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 177Lu-PSMA-617 with adjuvant Temozolomide (TMZ) over two cycles

8 weeks

2 infusions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including MRI every 2 months and a 68Ga-PSMA-PET scan 1 month after the second cycle

2 years

What Are the Treatments Tested in This Trial?

Interventions

• 177Lu-PSMA-617

Trial Overview The study is testing the safety of a radiopharmaceutical therapy called 177Lu-PSMA-617 in treating certain brain tumors. It includes Temozolomide treatment, imaging tests like 68Ga-PSMA-PET scans/MRI, and assessing patient quality of life through questionnaires.

How Is the Trial Designed?

Group I: 177Lu-PSMA-617 Experimental Treatment 4 Interventions

Patients will begin the first and second cycles of adjuvant Temozolomide (TMZ) the night before the first and second infusions of 177Lu-PSMA-617, respectively. Post-treatment, MRI of the brain will be obtained every 2 months, as per standard of care. A 68Ga-PSMA-PET scan will be performed with the MRI of the brain 1 month after the second cycle of 177Lu-PSMA-617 and again at evidence of disease progression.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Novartis Pharmaceuticals

Industry Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Citations

1. clinical-genitourinary-cancer.com clinical-genitourinary-cancer.com/article/S1558-7673(25)00011-4/abstract

Activity of 177Lu-PSMA-617 in Patients With Advanced ... 177Lu-PSMA-617 (LuPSMA) is a proven life-prolonging therapy in patients with metastatic castration-resistant prostate cancer (mCRPC), little is known about its ...

2. jnm.snmjournals.org jnm.snmjournals.org/content/64/6/892

[177Lu]Lu-PSMA Therapy as an Individual Treatment ... In this study, we demonstrated that only a minority of patients with HGG were eligible for treatment with [177Lu]Lu-PSMA (12) and that the ...

3. thelancet.com thelancet.com/journals/ebiom/article/PIIS2352-3964(24)00103-8/fulltext

Potential of PSMA-targeting radioligand therapy for ... This study provides quantified evidence and modelled predictions for the potential of PSMA-based RLT for treatment of malignant brain tumours.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8391520/

PSMA Theranostics: Current Landscape and Future Outlook In the first prospective single-arm phase 2 study (LuPSMA), 177Lu-PSMA-617 has demonstrated PSA decline >50% in 57%, improvements in pain, and ...

5. ar.iiarjournals.org ar.iiarjournals.org/content/44/6/2297

Systematic Review of the First 40 Cases of 177 Lu-PSMA ... 177 Lu-PSMA can be used to treat non-prostatic cancer with PSMA expression. The toxicity of such treatment was low, and the outcome was relatively good.

6. journals.lww.com journals.lww.com/nuclearmed/fulltext/2020/12000/177lu__68ga_psma_theranostics_in_recurrent.39.aspx

177 Lu-/ 68 Ga-PSMA Theranostics in Recurrent ... After 3 cycles of 177Lu-PSMA-617, 68Ga-PSMA PET/CT showed significant reduction in PSMA uptake and regression in size of lesion on MRI with improvement in ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37269841/

Health-related quality of life and pain outcomes with [ 177 Lu ... Grade 3 or 4 haematological adverse events included decreased haemoglobin (80 [15%] of 529 assessable patients who received [177Lu]Lu-PSMA-617 plus standard of ...

8. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0251375

Long-term outcome of 177 Lu-PSMA-617 radioligand therapy ... Fifty-six percent of the patients are alive and have shown improved overall survival. Recently, a study on 225Ac-PSMA-617 in mCRPC patients from ...