Study on Sirolimus and Metronomic Chemotherapy for Children with High-Risk Solid Tumors
Sponsor: Emory University
ClinicalTrials ID:NCT04469530
This clinical trial is exploring whether adding sirolimus to a low-dose chemotherapy regimen can improve outcomes for children with high-risk solid tumors, compared to just monitoring them after standard treatment.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The main goal of this study is to see if using sirolimus, a drug that helps suppress the immune system, along with continuous low-dose chemotherapy, can help children with high-risk solid tumors stay cancer-free for longer. This treatment is given after they have completed their standard therapy. The study will compare this approach to simply observing patients after their standard treatment to see which is more effective in preventing the cancer from coming back within two years.
Description
Sirolimus, also known as rapamycin, is a drug that suppresses the immune system and has been used to prevent organ rejection in transplant patients. It also has properties that can slow down tumor growth. This study is testing sirolimus in combination with low-dose chemotherapy, which is given continuously, to see if it can help children with high-risk solid tumors remain cancer-free longer after their initial treatment.
The study includes three groups: children with high-risk solid tumors who are in remission after their first treatment, children with recurrent solid tumors who are in remission after a second round of treatment, and a control group of patients who will be observed without additional treatment. The goal is to see if the combination of sirolimus and chemotherapy can improve the chances of staying cancer-free compared to just observation.
Eligibility Criteria
Inclusion Criteria
- Children aged 12 months to 30 years.
- Must have a high-risk solid tumor outside the brain and be in complete remission or have minimal abnormalities after initial treatment.
- Types of eligible tumors include metastatic or unresectable osteosarcoma, Ewing sarcoma, high-risk rhabdomyosarcoma, and others.
- Must have had a confirmed diagnosis of cancer at the start or relapse.
- Must be in good health with a performance status score of 50% or higher.
- Must have recovered from previous cancer treatments and have adequate blood cell counts and organ function.
- Must have normal kidney, liver, and lung function as determined by specific tests.
Exclusion Criteria
- Pregnant or breastfeeding women cannot participate.
- Participants must agree to use effective birth control during and for three months after treatment.
- Cannot be taking certain medications, including corticosteroids, enzyme-inducing anticonvulsants, or other investigational drugs.
- Cannot have an uncontrolled infection.
- Cannot be enrolled in another clinical trial for their cancer treatment.
- Must be able to comply with the study's safety monitoring requirements.
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.