A Study of Reduced-dose Radiation in People With Metastatic Tumors With a Genetic Change

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.

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Key information

Conditions

Metastatic Cancer Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hereditary Sensory and Autonomic Neuropathies Heredodegenerative Disorders, Nervous System Neoplasm Metastasis Neoplasms Neoplastic Processes Nervous System Diseases Nervous System Malformations Neurodegenerative Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Polyneuropathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Sloan Kettering Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Palliative radiotherapy

Radiation

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.

Primary outcomes

Treatment failure rate of irradiated lesion

Time frame: up to 12 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Amy Xu, MD, PhD

CONTACT

[email protected]

646-888-6863

Daniel Gomez, MD

CONTACT

212-639-2087

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2027
Study completion: 2027
First posted: Aug 18, 2021
Registry last updated: May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting