Pro-GRID Therapy for Advanced Cancer

(ProGRID Trial)

Overseen By Jean Wright, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Disqualifiers: Age < 18, ECOG 3-4, pregnancy, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

11 Participants Needed

Trial Summary

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 makes the Pro-GRID treatment unique for advanced cancer?

The Pro-GRID treatment is unique because it uses a novel approach involving engineered cell-based therapies encapsulated in micropore-forming capsules, which can be cultured before transplantation to solid tumors. This method allows for the sustained release of therapeutic proteins and oncolytic viruses, providing prolonged anti-tumor effects and offering an off-the-shelf strategy for local treatment of solid tumors. ^{1 2 3 4 5}

What is the purpose of this trial?

This is a single arm, phase I study, evaluating the feasibility, toxicity, and degree of tumor response after novel proton pencil beam scanning (PBS GRID) treatment in patients with bulky tumors that are difficult to manage.

Research Team

Jean Wright, MD

Principal Investigator

Radiation Oncology, SOM

Eligibility Criteria

This trial is for adults over 18 with large tumors (over 7 cm) like sarcoma or melanoma, who need palliative care to relieve symptoms. They should be fairly active (ECOG status <2), able to consent, and have discussed treatment with a specialist. It's not for those under 18, very ill patients (ECOG status 3-4), pregnant women, or if the tumor wraps around vital parts.

Inclusion Criteria

Willing and able to provide informed consent

You need to talk to a cancer doctor or a surgeon.

I have had radiation therapy and can provide the necessary images if needed.

Exclusion Criteria

For patients with prior RT that overlaps with Pro-GRID: Dicoms not available Pregnant women

I spend most of my day in bed or sitting due to my health.

My treatment is aimed at completely curing my condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a one-time high dose radiation treatment using proton pencil beam scanning GRID therapy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Multiple visits at 1, 6, and 12 months post-treatment

Treatment Details

Interventions

• Pro-GRID

Trial Overview The study tests Proton Pencil Beam Scanning GRID (Pro-GRID) therapy on bulky tumors. This phase I trial aims to see how safe it is and how well it works in shrinking these hard-to-treat tumors. All participants will receive this novel treatment without comparison to another group.

Participant Groups

Group I: Pro-GRID treatment Arm Experimental Treatment 1 Intervention

Patients enrolled in this study will receive spatially-fractionated radiotherapy or GRID-therapy, which involves delivering a one-time treatment of high dose radiation to small amounts of tumor in a manner that creates alternating regions of high and low dose radiation within the tumor. Patients will receive 2 (lowest dose) to 18 Gy (highest dose) in a single fraction.

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials

578

Recruited

33,600+

References

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

The Effect of Dynamic, In Vivo-like Oxaliplatin on HCT116 Spheroids in a Cancer-on-Chip Model Is Representative of the Response in Xenografts. [2022]

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

Esterase-responsive and size-optimized prodrug nanoparticles for effective intracranial drug delivery and glioblastoma treatment. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Application of a 3D hydrogel-based model to replace use of animals for passaging patient-derived xenografts. [2023]

4. France pubmed.ncbi.nlm.nih.gov

Engineered cell-based therapies in ex vivo ready-made CellDex capsules have therapeutic efficacy in solid tumors. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Real-time evaluation of a hydrogel delivery vehicle for cancer immunotherapeutics within embedded spheroid cultures. [2022]