Testing lower doses of radiation for metastatic tumors with ATM mutations
Phase II Study to Examine Precision Radiation in Patients With Pathogenic Mutations in ATM
This study is testing whether lower doses of radiation can effectively treat metastatic tumors with ATM mutations in patients who need palliative care.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 7 sites (Basking Ridge, New Jersey and 6 other locations) |
| Trial ID | NCT05010031 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of reduced-dose radiotherapy in treating metastatic tumors that have a pathogenic mutation in the ATM gene. Researchers will determine the minimum effective radiation dose that can still provide therapeutic benefits for patients with these specific tumors. The study focuses on patients who are referred for palliative radiotherapy and have a confirmed malignancy with at least one metastatic lesion. The goal is to improve treatment outcomes while minimizing radiation exposure.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with metastatic cancer and a confirmed pathogenic mutation in the ATM gene.
Not a fit: Patients with serious medical co-morbidities or those who have previously received radiotherapy to the treatment site may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and safer treatment options for patients with metastatic cancer and ATM mutations.
How similar studies have performed: Other studies have explored reduced-dose radiation in various contexts, but this specific approach targeting ATM mutations is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically confirmed malignancy with at least one metastatic lesion referred for palliative radiotherapy * Pathogenic mutation in ATM (somatic and germline allowed) * ECOG performance status 0-2 * Age ≥ 18 years. * Able to provide informed consent. * Patients at reproductive potential must agree to practice an effective contraceptive method during radiation treatments. * Expected life expectancy of at least 6 months Exclusion Criteria: * Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances. * Serious medical co-morbidities precluding radiotherapy. * Pregnant or breast-feeding women. * Lesions excluded from de-escalation include regions in which the risk of local disease progression is unacceptably high, including CNS disease and cord compression, and areas in which re-irradiation would not be feasible, including spinal cord overlap.
Where this trial is running
Basking Ridge, New Jersey and 6 other locations
- Memorial Sloan Kettering Basking Ridge (All Protocol Activities) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth (All protocol activities) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (All protocol activities) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Commack (All protocol activities) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (All Protocol Activities) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (All protocol activities) — Uniondale, New York, United States (Recruiting)
Study contacts
- Principal investigator: Amy Xu, MD, PhD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Amy Xu, MD, PhD
- Email: xua@mskcc.org
- Phone: 646-888-6863
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.