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| Diagnosis | Relapsed/Refractory Solid tumor, CNS tumor or lymphoma | Study Status | Open |
| Phase | I/II |
| Age | 0 Years to 21 Years | Randomisation | NO |
| Line of treatment | Disease relapse or progression |
| Routes of Treatment Administration | Arm A | Drug: Irinotecan (IV), Temozolomide (Oral), Paxalisib (Oral) |
| Last Posted Update | 2025-06-10 |
| ClinicalTrials.gov # | NCT06208657 |
International Sponsor
Australian & New Zealand Children's Haematology/Oncology GroupPrincipal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Daniel MorgensternCentres
Study Description
Both Australia (Zero Childhood Cancer) and Canada (PROFYLE) have programs that study the genetics of childhood cancers to help find better treatments. OPTIMISE is a study that matches patients with new treatments based on their tumor’s genetic profile. The study tests different treatment combinations to find the most effective ones for children with cancer.
Inclusion Criteria
- Patients must have a type of cancer that hasn't responded to regular treatment or doesn't have a good treatment option
- They must be under 21 years old. 21 years and older may be considered with approval if they have a childhood-type cancer
- They need to be part of a precision medicine study (like PROFYLE, ZERO or equivalent)
- Must meet tumor measurement requirements
- Must be up and about at least 50% of patients waking hours
- Patients need to be fully recovered from past treatments
- Must meet all organ function and bloodwork requirements
- Must agree to allowable methods of birth control. Participants may not be pregnant on this study.
- Must agree to sign a consent form and to the study activities
Other inclusion and exclusion criteria may apply and will be discussed with you by the study team.
