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Proton Pencil Beam Scanning GRID for Treatment of Bulky Tumors (ProGRID)

Primary Purpose

Sarcoma, Melanoma

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Pro-GRID

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring Spatially-fractionated radiotherapy, GRID-therapy, Proton therapy, Sarcoma, Melanoma, Treatment resistant tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sibley Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Pro-GRID treatment Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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).

Full Information

NCT ID

NCT05121545

First Posted

November 4, 2021

Last Updated

May 30, 2023

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

1. Study Identification

Unique Protocol Identification Number

NCT05121545

Brief Title

Proton Pencil Beam Scanning GRID for Treatment of Bulky Tumors

Acronym

ProGRID

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 6, 2022 (Actual)

Primary Completion Date

December 2025 (Anticipated)

Study Completion Date

December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sarcoma, Melanoma

Keywords

Spatially-fractionated radiotherapy, GRID-therapy, Proton therapy, Sarcoma, Melanoma, Treatment resistant tumors

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

This is a single arm phase I study design, evaluating the feasibility (primary endpoint), toxicity (secondary endpoint), and degree of response (exploratory endpoint) after proton GRID therapy in patients with bulky tumors.

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pro-GRID treatment Arm

Arm Type

Other

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Pro-GRID

Other Intervention Name(s)

Multi-beam proton Pencil Beam Scanning (PBS), termed Pro-GRID

Intervention Description

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.

Primary Outcome Measure Information:

Title

Feasibility of the Pro-GRID intervention as assessed by success of intervention delivery for a number of participants

Description

Time Frame

1.5 years

Secondary Outcome Measure Information:

Title

Rate of toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE v4)

Description

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.

Time Frame

3 months post-treatment

Title

Change in rate of treatment response of bulky tumors treated and not treated with proton GRID therapy

Description

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.

Time Frame

1, 6 and 12 months post-treatment

Title

Change in degree of treatment response of bulky tumors treated and not treated with proton GRID therapy

Description

Change in degree of treatment response would be measured by RECIST criteria (partial response, complete response, stable disease, or progression of disease).

Time Frame

1, 6 and 12 months post-treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jean Wright, MD

Phone

410-502-6795

jwrigh71@jhmi.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Dana Kaplin, MPH

Phone

410-502-6795

dkaplin1@jhmi.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean Wright, MD

Organizational Affiliation

Radiation Oncology, SOM

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sibley Memorial Hospital

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20016

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jean Wright, MD

Phone

202-537-4788

jwrigh71@jhmi.edu

First Name & Middle Initial & Last Name & Degree

Aditya Halthore, MD

ahaltho1@jhmi.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Proton Pencil Beam Scanning GRID for Treatment of Bulky Tumors

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