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

Metastatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05010031
• Other study ID #: 21-310
• Status: Recruiting
• Phase: Phase 2
• Start date: August 11, 2021
• Est. completion date: August 2026

Study information

• Verified date: June 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Amy Xu, MD, PhD
• Phone: 646-888-6863
• Email: xua[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 29
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Radiation:
• Palliative 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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (All Protocol Activities)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Commack (All protocol activities)	Commack	New York
United States	Memorial Sloan Kettering Westchester (All Protocol Activities)	Harrison	New York
United States	Memorial Sloan Kettering Monmouth (All protocol activities)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (All protocol activities)	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York
United States	Memorial Sloan Kettering Nassau (All protocol activities)	Uniondale	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	6 month

External Links

•   Memorial Sloan Kettering Cancer Center