Phase 1a/b Trial of Exercise as Interception Therapy for Primary High-Risk Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Exercise
- Conditions
- Breast Cancer
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 33
- Locations
- 16
- Primary Endpoint
- Identify the recommended phase 2 dose (RP2D) of exercise for testing in the phase 1b.
- Status
- Active, not recruiting
- Last Updated
- 2 months ago
Overview
Brief Summary
Researchers think that exercise may be able to prevent cancer from coming back by lowering ctDNA levels. The purpose of this study is to explore how aerobic exercise (exercise that stimulates and strengthens the heart and lungs and improves the body's use of oxygen) can reduce the level of ctDNA found in the blood. During the study, the highest level of exercise that is practical, is safe, and has positive effects on the body that may prevent the return of cancer (including a decrease in ctDNA levels) will be found. Each level of exercise tested will be a certain number of minutes each week. Once the best level of exercise is found, it will be tested further in a new group of participants. All participants in this study will have been previously treated for breast, prostate, or colorectal cancer.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Postsurgical diagnosis of patients with primary solid tumors at high-risk of relapse as defined by one of the following:
- •° High-risk primary solid tumor (e.g., colorectal, ovarian, non-small cell lung cancer) (colorectal cancer only for Phase 1a)
- •Stage 3 or
- •ctDNA positive
- •° High-risk breast cancer
- •Residual invasive disease in the breast or the lymph nodes following completion of neoadjuvant chemotherapy (NACT),
- •Estrogen receptor (ER), and/or progesterone receptor (PR) positive and HER2 negative,
- •CPS-EG score ≥ 3,
- •CPS-EG score ≥2 w ith ypN+, or
- •Recurrence score ≥ 25
Exclusion Criteria
- •Enrollment onto any other interventional investigational study except interventions determined by the PI not to confound study outcomes
- •Any other current diagnosis of invasive cancer of any kind
- •Distant metastatic malignancy of any kind
- •Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation
Arms & Interventions
Dose-Finding/Escalation
Fifty (n=50) post-treatment patients with colorectal cancer or breast cancer, deemed high-risk of relapse. The study will use an adaptive continuous reassessment method (CRM) design to assign patients sequentially at trial entry to one of five escalated doses depending on the feasibility / tolerability of exercise therapy evaluated over the total treatment period. The primary objective of this phase 1a trial is to identify the RP2D of exercise therapy for further evaluation in the phase 1b trial.
Intervention: Exercise
Dose Expansion
An independent cohort of 30 post-treatment patients with colorectal (n=15) or breast (n=15) cancer deemed high-risk of relapse. This cohort expansion trial will only evaluate the RP2D identified in the phase 1a trial. The primary objective of this phase 1b trial is to further evaluate the feasibility, safety, and biological activity of the RP2D.
Intervention: Exercise
Outcomes
Primary Outcomes
Identify the recommended phase 2 dose (RP2D) of exercise for testing in the phase 1b.
Time Frame: 24 weeks
Using an adaptive phase 1 (non-randomized) design, non-exercising (i.e., \<60 mins/wk of moderate or vigorous exercise) post-treatment patients with primary breast, prostate, or colorectal cancer and detectable ctDNA (n=50) will be administered one of five escalating dose levels.