Generating Novel Translational and Therapeutic Strategies Based on a Multicenter, Pediatric and AYA Evolutionary Tumor Board (pedsETB)

H. Lee Moffitt Cancer Center and Research Institute

Status: Enrolling

Conditions: Pediatric Cancer

Treatments: Other: Peds Evolutionary Tumor Board (pedsETB)

Study type: Observational

Funder types: Other

Identifiers

NCT06423950

MCC-22170

Details and patient eligibility

About

To evaluate the ability of a multidisciplinary and multisite group, the Pediatric Evolutionary Tumor Board (pedsETB), to develop additional therapeutic strategies in patients without curative options or with suboptimal outcomes.

Enrollment: 35 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant must be considered likely incurable given the standard of care. This is inclusive of patients newly diagnosed, relapsed or in remission but at high risk of recurrence, with suboptimal responses to previous therapy, or with many potentially beneficial, but unlikely curative options for care.

The site investigator will make this determination based on their experience.

• Participant must have an age-appropriate performance status: Karnofsky 50 or more for patients 16 years of age or older OR Lansky score of 50 or more for patients less than16 years of age.
• Participant and/or parents or legal guardian and primary oncologist must be willing to consider the therapeutic strategies recommended by the pedsETB.
• Participant must be willing to be followed over time and allow collection of clinical data including scans, available blood and lab samples, and optional pedsETB serial blood sampling.
• All Participants and/or their parents or legal guardians must have the ability to understand and the willingness to sign a written informed consent or assent document.

Exclusion criteria

• Participants without known therapies to reliably induce a response are excluded from pedsETB and should seek clinical trials.

Trial design

35 participants in 1 patient group

Participants Reviewed by ETB

Description:

Participants clinical history, available therapeutic options, and outcome expectations will be presented to the Evolutionary Tumor Board (ETB) along with images and pathology. Strategies and models will be presented regarding additional evolutionary ideas that can be applied. These ideas will be characterized (e.g. first strike-second strike, adaptive, novel sequential therapy, novel combination, novel dosing schedule, etc.).

Treatment:

Other: Peds Evolutionary Tumor Board (pedsETB)