RecruitingPhase 2NCT05010031

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

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

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

40 participants

Start Date

Aug 11, 2021

Study Type

INTERVENTIONAL

Conditions

Metastatic Cancer

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

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 Criteria4

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.

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Interventions

RADIATIONPalliative radiotherapy

An initial cohort of 12 evaluable patients will be treated with 4Gyx2, with adaptive dosing planned for expansion cohorts pending the number of failures observed after 6 month observation of the initial cohort.