89Zr-cRGDY Tracer for Brain Cancer

Overseen By Heiko Schöder, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Pregnancy, Breast-feeding, Cardiac disease, others

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

Compensation: Varies

Number of Visits: 1

17 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new type of PET scan that uses tiny particles to take clearer pictures of brain tumors. The study aims to see how these particles spread and leave the body. This could help improve future treatments for brain tumor patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the drug 89Zr-DFO-cRGDY-PEG-Cy5-C' dots for brain cancer?

Research on similar treatments, like PEGylated RGD peptides, shows they can effectively target brain tumors and provide high tumor-to-background contrast in imaging, which suggests potential for effective tumor targeting in brain cancer. ^{1 2 3 4 5}

Is the 89Zr-cRGDY tracer safe for use in humans?

The studies on similar tracers, like PEGylated RGD peptides, show they are generally well-tolerated in animal models, with no obvious toxicity observed. However, specific safety data for 89Zr-cRGDY in humans is not provided in the available research. ^{3 5 6 7 8}

What makes the 89Zr-cRGDY tracer treatment unique for brain cancer?

The 89Zr-cRGDY tracer treatment is unique because it uses a special imaging technique called PET (positron emission tomography) to target specific proteins involved in tumor growth, allowing for precise visualization of brain tumors. This approach combines a radioactive element, zirconium-89, with a peptide that targets proteins like VEGFR and integrins, which are often over-expressed in cancer cells, making it a novel option for imaging and potentially treating brain cancer. ^{3 7 9 10 11}

Research Team

Nelson Moss, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for adults over 18 with confirmed malignant brain tumors, pituitary adenomas, or brain metastases from known cancers. Participants must use birth control if of childbearing age and have normal heart function. Pregnant or breastfeeding individuals, those with multiple active cancers, severe claustrophobia, or weight over 400 lbs cannot join.

Inclusion Criteria

All patients of childbearing age must use an acceptable form of birth control

I am 18 years old or older.

If you are a woman who has not gone through menopause, you must have a negative pregnancy test.

Exclusion Criteria

I have cancer that has spread from my brain to other parts of my body.

Known pregnancy or breast-feeding

Medical illness unrelated to the tumor which in the opinion of the attending physician and principal investigator will preclude administration of the tracer

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Microdosing Study

Participants receive an intravenous injection of 89Zr-DFO-cRGDY-PEG-Cy5-C' dots and undergo PET brain imaging to collect particle tracer kinetic and dosimetry data

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

Treatment Details

Interventions

• 89Zr-DFO-cRGDY-PEG-Cy5-C' dots

Trial Overview The study tests a new PET scan tracer called 89Zr-DFO-cRGDY-PEG-Cy5-C' dots to see how well it can image brain tumors and track its distribution and removal in the body. This is the first time these particles are used in humans after being tested in mice.

Participant Groups

Group I: surgical patients Experimental Treatment 2 Interventions

Patients will be i.v. injected with approximately 5 mCi (\~3.4-6.7 nanomoles) of 89Zr-DFO-cRGDY-PEG-Cy5-C' dots (specific activity range 750.0 - 1450 mCi/ µmol) and undergo the microdosing study for purposes of collecting particle tracer kinetic and dosimetry data. The patient's PET/CT Brain scans may be acquired prior to surgery. All non-surgical and some surgical patients (at the discretion of the physician) will undergo PET brain imaging.

Group II: non-surgical patients Experimental Treatment 2 Interventions

Before the patient's PET Brain scans patients will be i.v. injected with approximately 5 mCi (\~3.4-6.7 nanomoles) of 89Zr-DFO-cRGDY-PEG-Cy5-C' dots (specific activity range 750.0 - 1450 mCi/ µmol) and undergo the microdosing study for purposes of collecting particle tracer kinetic and dosimetry data. All non-surgical and some surgical patients (at the discretion of the physician) will undergo PET brain imaging

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Findings from Research

ADI-PEG20, an arginine-depleting drug, significantly reduces the growth of ASS1 negative glioblastoma multiforme (GBM) tumors in an intracranial model, extending survival without causing obvious toxicity.

When combined with temozolomide, ADI-PEG20 enhances therapeutic effects in both ASS1 negative and ASS1 positive GBM, suggesting a promising treatment strategy that circumvents the blood-brain barrier.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of arginine depletion by ADI-PEG20 in an intracranial model of GBM. Przystal, JM., Hajji, N., Khozoie, C., et al.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Utility of Tc-PEG4-E[PEG4-c(RGDfK)]2 in Posttherapy Surveillance of Patients with Reelevated Carcinoembryonic Antigen Levels. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Conjugation of glucosylated polymer chains to checkpoint blockade antibodies augments their efficacy and specificity for glioblastoma. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Glioblastoma Multiforme Recurrence: An Exploratory Study of (18)F FPPRGD2 PET/CT. [2017]

4. England pubmed.ncbi.nlm.nih.gov

Enhanced tumour specificity of an anti-carcinoembrionic antigen Fab' fragment by poly(ethylene glycol) (PEG) modification. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

MicroPET imaging of brain tumor angiogenesis with 18F-labeled PEGylated RGD peptide. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Efficacy of arginine depletion by ADI-PEG20 in an intracranial model of GBM. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Pegylated Arg-Gly-Asp peptide: 64Cu labeling and PET imaging of brain tumor alphavbeta3-integrin expression. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Synthesis and comparative in vivo evaluation of 99m Tc(CO)3 -labeled PEGylated and non-PEGylated cRGDfK peptide monomers. [2018]

9. England pubmed.ncbi.nlm.nih.gov

PET imaging of VEGFR and integrins in glioma tumor xenografts using 89Zr labelled heterodimeric peptide. [2022]

10. United Arab Emirates pubmed.ncbi.nlm.nih.gov

89Zr-PET radiochemistry in the development and application of therapeutic monoclonal antibodies and other biologicals. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

Biodistribution of the ¹⁸F-FPPRGD₂ PET radiopharmaceutical in cancer patients: an atlas of SUV measurements. [2018]