Reducing frailty in adult survivors of childhood cancer
SEN-SURVIVORS: An Open-Label Intervention Trial to Reduce Senescence and Improve Frailty in Adult Survivors of Childhood Cancer
This study is testing two different treatments to see if they can help adult survivors of childhood cancer feel less frail and improve their overall health.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | St. Jude Children's Research Hospital Academic / other |
| Drugs / interventions | Dasatinib, chemotherapy, radiation |
| Locations | 1 site (Memphis, Tennessee) |
| Trial ID | NCT04733534 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the efficacy, safety, and tolerability of two senolytic regimens—Dasatinib plus Quercetin and Fisetin alone—in improving frailty and reducing cellular senescence in adult survivors of childhood cancer. Participants will be randomized and receive either treatment over a short duration, with primary outcomes measured by changes in walking speed and levels of senescent cells in the blood. Follow-up assessments will occur at 60 and 150 days to determine the effectiveness and permanence of the treatment effects.
Who should consider this trial
Good fit: Ideal candidates are adult survivors of childhood cancer who are frail and have been diagnosed for over five years.
Not a fit: Patients with active malignancies, severe infections, or those currently undergoing chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the quality of life for adult survivors of childhood cancer by reducing frailty.
How similar studies have performed: While this approach is novel in this specific population, similar senolytic interventions have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participant in SJLIFE and \> 5 years from diagnosis. * ≥18 years of age. * Frail (2 of 4 objectively measured Fried criteria adapted,(excluding self-reported fatigue as a criteria), including abnormal walking speed; muscle strength; activity level; and muscle mass). See Section 5 for details. * CD3+ T lymphocytes: p16INK4A detected at \<34 cycles by RT PCR. * Agrees to use contraception as Dasatinib is teratogenic. * Female participant has a negative pregnancy test. * QTc \<450 milliseconds in electrocardiogram. * Able to take oral medications. Exclusion Criteria: * Currently has HIV, Hepatitis B/C, invasive fungal infection * Anemia or as per clinical judgement. * Hypersensitivity to study drugs * New/active malignancy/taking chemotherapy and/or radiation except non-melanoma skin cancers * Currently taking medications that inhibit or induce CYP3A4 or that are sensitive to substrates or substrates with a narrow therapeutic range for CYP2C8, CYP2C9, or CYP2D6. * Taking anticoagulants or antimicrobial agents * Currently taking Quercetin or Fisetin * Pregnant or nursing at time of enrollment/during the study * Impaired cognition or motor performance due to congenital defects * Currently participating in another research intervention to aid walking speed or other measures of frailty including muscle strength; low activity; muscle mass or exhaustion/fatigue * Participant is a Non-English Speaker * Uncontrolled pleural/pericardial effusion or ascites * Subjects on anticoagulant or antiplatelet agents (Warfarin, Clopidogrel \[Plavix\]; Dipyridamole + Aspirin \[Aggrenox\]; Ticagrelor \[Brilintal\]; Prasugrel \[Effient\]; Ticlopidine \[Ticlid\]; or other) who are unable or unwilling to reduce or hold therapy prior to and during the 2-3 day drug dosing. Subjects may continue their previous regimen after drug dosing is complete. * Cognitive impairment defined by IQ \<80 * Diagnosis of a psychotic disorder * Laboratory tests as indicated or as per clinical judgement * Severe hepatic dysfunction with ALT/AST \> 3 times upper limit of normal. * Total bilirubin \> 2 times upper limit of normal. * eGFR \<25 ml/min/1.73m2 or as per clinical judgement. * Hemoglobin \< 7 g/dl; white blood cell count ≤2,000/mm3 (≤2.0 x 109/L) or ≥20,000/mm3 (≥20 x 109/L); platelet count ≤40,000/μL (≤40 x 109/L); absolute neutrophil count ≤1 x 109/L; lymphocyte count \<0.3 x 109/L at screening as a marker of poor nutrition * Fasting glucose \>300. * Participant is unable to ambulate
Where this trial is running
Memphis, Tennessee
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Gregory T. Armstrong, MD, MSCE — St. Jude Children's Research Hospital
- Study coordinator: Gregory T. Armstrong, MD, MSCE
- Email: referralinfo@stjude.org
- Phone: 866-278-5833
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.