Pro-GRID Therapy for Advanced Cancer
(ProGRID Trial)

Recruiting in Palo Alto (17 mi)

Overseen byJean Wright, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

No Placebo Group

Trial Summary

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.

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.

+6 more

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.

+2 more

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: Pro-GRID treatment ArmExperimental Treatment1 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.