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RecruitingInterventionalPhase 2

Phase II Study to Examine Precision Radiation in Patients With Pathogenic Mutations in ATM

NCT ID: NCT05010031Sponsor: Memorial Sloan Kettering Cancer CenterLast updated: 2026-05-11

Summary

This study will test whether reduced-dose radiotherapy is an effective treatment for metastatic tumors with an ATM mutation. The researchers want to find the lowest dose of radiation that would still be effective to treat these tumors.

Arms & interventions

  • RadiationPalliative radiotherapy

    Initial cohort (stage 1) of patients will receive 4Gy x 2. They will be re-evaluated at 2 and 6 months (+/- 2 weeks). Accounting for anticipated survival times of these patients, we expect to have 12 evaluable patients from 20 enrolled patients. For stage 2 dose reduction will be explored across two palliative regimens, with timepoint for local failure adjusted accordingly.

Outcome measures

Primary

  • Treatment failure rate of irradiated lesion

    Defined as (i) radiographic progression or (ii) re-irradiation to the treated site. If PET is performed, radiographic criteria will be evaluated per PERCIST

    Time frame: up to 12 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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.

Study locations (7)

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, 10065

Recruiting
Amy Xu, MD, PhD · Contact

Memorial Sloan Kettering Monmouth (All protocol activities)

Middletown, New Jersey, 07748

Recruiting
Amy Xu, MD, PhD · Contact

Memorial Sloan Kettering Bergen (All protocol activities)

Montvale, New Jersey, 07645

Recruiting
Amy Xu, MD, PhD · Contact

Memorial Sloan Kettering Commack (All protocol activities)

Commack, New York, 11725

Recruiting
Amy Xu, MD, PhD · Contact

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, 10604

Recruiting
Amy Xu, MD, PhD · Contact

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065

Recruiting
Amy Xu, MD, PhD · Contact
Daniel Gomez, MD · Contact
Amy Xu, MD, PhD · Principal Investigator

Memorial Sloan Kettering Nassau (All protocol activities)

Uniondale, New York, 11553

Recruiting
Amy Xu, MD, PhD · Contact
A Study of Reduced-dose Radiation in People With Metastatic Tumors With a Genetic Change | Cancerify