Atezolizumab + Chemotherapy for Pediatric Solid Cancers
Trial Summary
What is the purpose of this trial?
This trial is a multi-center, non-randomized, open-label Phase I/II study evaluating the feasibility and efficacy of vincristine, irinotecan, temozolomide, and atezolizumab in children with relapsed/refractory solid tumors.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, there are specific washout periods for certain treatments, such as chemotherapy, radiotherapy, and some immunosuppressive medications, before starting the study treatment. It's best to discuss your current medications with the trial team to understand any necessary adjustments.
What data supports the effectiveness of the drug Atezolizumab + Chemotherapy for Pediatric Solid Cancers?
Is the combination of Atezolizumab, Irinotecan, Temozolomide, and Vincristine safe for children with solid tumors?
Research shows that the combination of Irinotecan and Temozolomide has been tested in children with solid tumors and found to be generally tolerable, though some patients experienced side effects like diarrhea, low white blood cell counts (neutropenia), and low platelet counts (thrombocytopenia). Vincristine has also been tested in combination with these drugs, and while it can cause side effects, the combination has been used in children with relapsed solid tumors.678910
What makes the drug combination of Atezolizumab, Irinotecan, Temozolomide, and Vincristine unique for pediatric solid cancers?
This drug combination is unique because it includes Atezolizumab, an immunotherapy that helps the immune system fight cancer, alongside a chemotherapy regimen of Irinotecan, Temozolomide, and Vincristine, which have shown effectiveness in treating relapsed or refractory pediatric solid tumors. This combination leverages both the immune system and traditional chemotherapy to target difficult-to-treat cancers.6781112
Research Team
Matthew Campbell, MD
Principal Investigator
UT Southwestern Medical Center
Eligibility Criteria
This trial is for children and young adults aged 6 months to 30 years with relapsed or refractory solid tumors, including rhabdomyosarcoma. Participants must have had at least one prior therapy, meet specific health criteria (like organ function tests), agree to use effective contraception if of childbearing potential, and be able to follow the study protocol.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Feasibility Cohort Treatment
Participants receive vincristine, irinotecan, temozolomide, and atezolizumab to determine feasibility
RMS Efficacy Cohort Treatment
Participants with rhabdomyosarcoma receive the combination treatment to evaluate efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Atezolizumab
- Irinotecan
- Temozolomide
- Vincristine
Atezolizumab is already approved in United States, European Union for the following indications:
- Melanoma
- Hepatocellular carcinoma
- Small cell lung cancer
- Non-small cell lung cancer
- Urothelial carcinoma
- Melanoma
- Hepatocellular carcinoma
- Small cell lung cancer
- Non-small cell lung cancer
- Urothelial carcinoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Matthew Campbell
Lead Sponsor
University of Texas Southwestern Medical Center
Lead Sponsor