PrOton Pulsed reduCed dOse Rate Radiotherapy for Recurrent CNS maligNancies Trial

Study Purpose

The purpose of this research study is to see if a specific type of radiation therapy, called "proton pulsed reduced dose rate" or "PRDR radiotherapy" has any benefits at dose levels and number of fractions thought to be acceptable in earlier research studies. The researchers want to find out what effects (good and bad) PRDR has on people with cancer in the brain called a "recurrent high-grade glioma" meaning that it grows fast, can spread quickly, and it has come back or gotten worse after being treated previously.

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:

- Karnofsky performance status ≥ 50.

- Histologically-confirmed or radiographic evidence of recurrent / progressive glioma.

- Prior treatment with radiotherapy to a minimum dose of 45 Gy.

- At least 6 months or greater between completion of prior radiotherapy and enrollment in this study.

If prospective participants have not passed an interval of at least 6 months, they may still be eligible if they meet one or more of the following criteria: 1. New areas of tumor outside the original radiotherapy fields as determined by the investigator. 2. Histologic confirmation of tumor through biopsy or resection AND an interval of at least 90 days between completion of radiotherapy and enrollment. 3. Nuclear medicine imaging, magnetic resonance (MR) spectroscopy, or MR perfusion imaging consistent with true progressive disease, rather than radiation necrosis obtained within 28 days of enrollment AND an interval of at least 90 days between completion of radiotherapy and enrollment.

- Must have recovered from grade 3+ toxicities of prior therapy and there must be a minimum time of 28 days prior to enrollment from the administration of any investigational agent or prior cytotoxic therapy.

- Must not be pregnant (positive pregnancy test) or breastfeeding.

Must agree to use of highly effective contraception during radiotherapy treatment and for an additional 6 months. Should a participant become pregnant or suspect that they are pregnant while participating in this study, they should notify the treating physician immediately. Highly effective and acceptable forms of contraception are:

- Male condom plus spermicide.

- Cap plus spermicide.

- Diaphragm plus spermicide.

- Copper T.

- Progesterone T.

- Levonorgestrel-releasing intrauterine system (e.g., Mirena®) - Implants.

- Hormone shot or injection.

- Combined pill.

- Mini-pill.

- Patch.

Individuals who meet any of the following criteria will not need contraception:

- Individuals assigned male at birth.

- Amenorrhoeic for 1 year or more following cessation of exogenous hormonal treatments.

- Luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the postmenopausal range for individuals under 50.

- Radiation-induced oophorectomy with last menses > 1 year ago.

- Chemotherapy-induced menopause with >1 year interval since last menses.

- Surgical sterilization (bilateral oophorectomy or hysterectomy)
Exclusion Criteria:
- Two or more courses of prior radiotherapy.

- Inability to undergo an MRI with contrast.

- Leptomeningeal evidence of recurrent disease.

- Multi-focal disease.

- Any other condition that may put a participant at higher risk, at the discretion of the investigator.

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.	NCT06397560
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.	Baptist Health South Florida
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Rupesh Kotecha, M.D.
Principal Investigator Affiliation	Miami Cancer Institute at Baptist Health, Inc.
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioma, Glioma, Malignant, Recurrent Glioma
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: PRDR Radiotherapy

Interventions

Radiation: - PRDR

Proton pulsed reduced dose rate (PRDR) technique, to a dose of 54 Gy in 30 fractions (treatments) with proton radiotherapy. Treatments will occur once per day on consecutive weekdays.

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.

Boca Raton, Florida

Status

Address

Lynn Cancer Institute at Baptist Health, Inc.

Boca Raton, Florida, 33437

Site Contact

Hina Saeed, M.D.

[email protected]

561-374-5440

Miami, Florida

Status

Address