Proton Pencil Beam Scanning GRID for Treatment of Bulky Tumors

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05121545
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jean Wright, MD
Principal Investigator Affiliation	Radiation Oncology, SOM
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Sarcoma, Melanoma

Additional Details

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.

Arms & Interventions

Arms

Other: Pro-GRID treatment Arm

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.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Sibley Memorial Hospital, Washington, District of Columbia

Status

Recruiting

Address

Sibley Memorial Hospital

Washington, District of Columbia, 20016

Site Contact

Jean Wright, MD

[email protected]

202-537-4788

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