Proton Pencil Beam Scanning GRID for Treatment of Bulky Tumors

Melanoma Clinical Trial

— ProGRID  

Official title:

A Phase 1 Study of Proton Pencil Beam Scanning GRID for Treatment of Bulky Tumors (ProGRID)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05121545
• Other study ID #: J2161
• Secondary ID: IRB00289810
• Status: Recruiting
• Phase: N/A
• Start date: April 6, 2022
• Est. completion date: December 2026

Study information

• Verified date: May 2023
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: Jean Wright, MD
• Phone: 410-502-6795
• Email: jwrigh71[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The proton group at Sibley Memorial Hospital has developed a new method for multi-beam proton delivery making it possible to arrange and optimize GRID dosimetry and normal tissue sparing compared to other similar techniques. In this phase I pilot study, patients with bulky tumors will receive this novel method of GRID-therapy also called spatially-fractionated radiotherapy which involves delivering high dose radiation to small amounts of tumor in a manner that creates alternating regions of high and low dose radiation within the tumor and is often aligned in a grid pattern. In so doing, this study will ascertain the feasibility, safety and tumor response i.e. shrinkage and resectability of this treatment. Ultimately, the goal is to improve local outcomes of patients with bulky tumors and to offer new treatment options for patients with difficult-to-manage bulky tumors.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18
• Histologically or cytologically confirmed invasive cancer
• Bulky tumor > 7 cm, determined clinically and/or radiographically, at the time of evaluation prior to enrollment
• Treated indicated for palliative intent
• Eastern Cooperative Oncology Group (ECOG) performance status < 2
• Anticipated treatment deemed safe on pre-review by PI
• For patients with prior Radiation Therapy (RT): Dicoms must be available for dose fusion if overlap anticipated with GRID
• Willing and able to provide informed consent
• Discussion with medical oncology or surgical specialty

Exclusion Criteria:

• Age < 18
• ECOG performance status 3-4
• Planned for definitive, curative management
• For patients with prior RT that overlaps with Pro-GRID: Dicoms not available Pregnant women
• Tumor encasing critical structure, as defined by the treating MD.

Related Conditions & MeSH terms

• Melanoma
• Sarcoma

Intervention

Radiation:
• Pro-GRID
Study participants will receive a single treatment of Pro-GRID therapy. After which, the participants would be able to resume standard therapy (after one week) and receive additional radiotherapy one month after Pro-GRID therapy, if recommended. Participants will be in the study for one year. Follow-up appointments will be scheduled at 1, 3, 6 and 12 months posttreatment, and may include a history and physical exam, labs and/or a CT scan and toxicity assessments.

Locations

Country	Name	City	State
United States	Sibley Memorial Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the Pro-GRID intervention as assessed by success of intervention delivery for a number of participants	To assess the feasibility of successfully creating treatment plans and delivering a novel proton therapy called Pro-GRID. Feasibility will be determined by a successful intervention delivery for 10 of 12 patients with bulky solid tumors.	1.5 years
Secondary	Rate of toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE v4)	To determine the rate of mild acute toxicity, defined as any CTCAE grade 2 or lower toxicity, and severe acute toxicity, defined as any CTCAE grade 3 or higher toxicity.	3 months post-treatment
Secondary	Change in rate of treatment response of bulky tumors treated and not treated with proton GRID therapy	To determine the change in response rate for bulky tumors treated and not treated with Proton GRID by Response Evaluation Criteria in Solid Tumours (RECIST) criteria.	1, 6 and 12 months post-treatment
Secondary	Change in degree of treatment response of bulky tumors treated and not treated with proton GRID therapy	Change in degree of treatment response would be measured by RECIST criteria (partial response, complete response, stable disease, or progression of disease).	1, 6 and 12 months post-treatment