Chemotherapy for Recurrent Solid Cancers in Children
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new combination of treatments for children whose solid tumors have returned after previous treatment. The trial combines three drugs—nanoparticle albumin-bound rapamycin (a form of chemotherapy), temozolomide, and irinotecan hydrochloride—to determine if they can stop cancer growth or help shrink tumors. The focus is on finding the right dose and understanding the side effects. Children with recurring solid tumors, including certain brain tumors, who have not found success with other treatments, might be suitable candidates for this trial. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new combination therapy.
Do I have to stop taking my current medications for the trial?
The trial requires that you stop taking certain medications before enrolling. You must not be on any other anti-cancer agents, investigational drugs, or therapeutic anticoagulants. Additionally, you should avoid strong CYP3A4 or P-glycoprotein inducers or inhibitors within 7 days prior to enrollment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that a drug called nanoparticle albumin-bound rapamycin tends to remain in tumors longer when used for cancer treatment. This enhances drug delivery and may reduce the risk of side effects. Previous studies have found that patients generally tolerate this treatment well.
Temozolomide has been tested in children with recurring brain and other types of tumors. Research indicates it can be effective, and most patients manage its side effects well.
Irinotecan hydrochloride has been studied in children with solid tumors. Some research suggests it can be used safely, but there isn't enough evidence yet to confirm its efficacy specifically in children. This indicates some experience with its use, but the full safety profile is still under investigation.
This trial is in the early phase, focusing on finding the safest dose and identifying any serious side effects. As a result, the treatment's complete safety in humans is still under study, but early research is promising.12345Why are researchers excited about this trial's treatments?
Researchers are excited about this treatment for recurrent solid cancers in children because it combines a novel drug delivery system with established cancer-fighting agents. Unlike standard chemotherapy, which often involves traditional drugs delivered in a typical form, this treatment uses nanoparticle albumin-bound rapamycin. This innovative approach allows for more targeted delivery of the drug, potentially increasing its effectiveness while reducing side effects. Additionally, combining this with temozolomide and irinotecan hydrochloride, which are known for their cancer-fighting properties, offers a comprehensive attack on the cancer cells, providing hope for better outcomes in children facing these challenging conditions.
What evidence suggests that this trial's treatments could be effective for recurrent solid cancers in children?
Research has shown that a treatment called nanoparticle albumin-bound rapamycin, or nab-sirolimus, might stop tumors from growing by blocking the enzymes cancer cells need. Early studies suggest it could be promising for children with difficult-to-treat tumors. In this trial, participants will receive a combination of treatments, including nab-sirolimus, Temozolomide, and Irinotecan hydrochloride. Temozolomide has been effective in children with recurring solid tumors, with about 42.5% of patients experiencing tumor shrinkage or halted growth. Irinotecan hydrochloride has also shown strong results in treating certain childhood tumors, such as hepatoblastoma, a type of liver cancer. Each treatment works differently to attack and shrink cancer cells, offering hope for children with recurring cancers.16789
Who Is on the Research Team?
Stuart L Cramer
Principal Investigator
COG Phase I Consortium
Are You a Good Fit for This Trial?
This trial is for pediatric patients with solid tumors, including brain and CNS tumors that have returned or didn't respond to treatment. They must have a body surface area of at least 0.2 m^2, measurable disease, no known curative therapy available, stable neurologic deficits if present, and recovered from previous cancer treatments. Pregnant or breastfeeding individuals are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive nanoparticle albumin-bound rapamycin IV on days 1 and 8, and temozolomide and irinotecan hydrochloride PO on days 1-5, repeating every 21 days for up to 35 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Irinotecan Hydrochloride
- Nanoparticle Albumin-Bound Rapamycin
- Temozolomide
Irinotecan Hydrochloride is already approved in United States, European Union, Canada, Japan for the following indications:
- Colorectal cancer
- Pancreatic cancer
- Colorectal cancer
- Pancreatic cancer
- Colorectal cancer
- Pancreatic cancer
- Colorectal cancer
- Pancreatic cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Oncology Group
Lead Sponsor
National Cancer Institute (NCI)
Collaborator