Childhood Cancer Clinical Trial
Official title:
Optimal Precision TherapIes to CustoMISE Care in Childhood and Adolescent Cancer
A companion platform trial to test novel targeted agents based on the patient's tumor profile.
Status | Not yet recruiting |
Enrollment | 82 |
Est. completion date | December 2035 |
Est. primary completion date | December 2030 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 0 Years to 21 Years |
Eligibility | Inclusion Criteria: 1. Patients must be diagnosed with a solid tumor, CNS tumor or lymphoma that has progressed despite standard therapy, or for which no effective standard therapy exists. 2. Age <21 years at inclusion; patients 21 years and older may be included after approval by the Study Chair if they have a pediatric type recurrent/refractory malignancy. 3. Patients must be enrolled on a precision medicine study (i.e. PROFYLE, ZERO or equivalent as agreed with Study Chair. 4. Patients enrolled in a Phase I cohort must have either evaluable or measurable disease. 5. Patients enrolled in a Phase II cohort must have measurable disease. Evaluable and measurable disease are defined by standard imaging criteria for the patient's tumor type. 6. Disease evaluations, laboratory tests, and other clinical assessments that are considered standard of care may be undertaken at the patient's local oncology treatment centre with results transferred to study site for evaluation. 7. Performance status: Karnofsky performance status (for patients > 16 years of age) or Lansky play score (for patients = 16 years of age) = 50%. 8. Life expectancy = 6 weeks. 9. Patients must have fully recovered from the acute toxic effects of all prior anticancer therapy and must meet the following minimum duration from prior anticancer-directed therapy prior to enrolment. 10. Adequate organ function. 11. Able to comply with scheduled follow-up and with management of toxicity. 12. Females of childbearing potential must have a negative serum or urine pregnancy test. 13. Fertile males must agree to use adequate contraception during the study and following completion of treatment. 14. Provide a signed and dated informed consent form. Exclusion Criteria: 1. Patients with symptomatic CNS primary or metastatic tumors who are neurologically unstable or require increasing doses of corticosteroids or local CNS-directed therapy to control their CNS disease. 2. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter drug absorption of oral drugs. 3. Clinically significant, uncontrolled heart disease. 4. Known active viral hepatitis or human immunodeficiency virus (HIV) infection or any other uncontrolled infection. 5. Presence of any =Grade 2 treatment-related toxicity. 6. Major surgery within 21 days of the first dose of investigational drug. 7. Known hypersensitivity to any study drug or component of the formulation. 8. Pregnant or nursing (lactating) females. 9. Any other concomitant serious medical condition or organ dysfunction that in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the investigational drugs. |
Country | Name | City | State |
---|---|---|---|
Australia | Women's and Children's Hospital | Adelaide | South Australia |
Australia | Queensland Children's Hospital | Brisbane | Queensland |
Australia | Monash Children's Hospital | Melbourne | Victoria |
Australia | Royal Children's Hospital | Melbourne | Victoria |
Australia | John Hunter Children's Hospital | Newcastle | New South Wales |
Australia | Perth Children's Hospital | Perth | Western Australia |
Australia | Sydney Children's Hospital, Randwick | Sydney | New South Wales |
Australia | The Children's Hospital at Westmead | Sydney | New South Wales |
Canada | CHU Sainte Justine | Montréal | |
Canada | The Hospital for Sick Children | Toronto | |
Canada | BC Children's Hospital | Vancouver |
Lead Sponsor | Collaborator |
---|---|
Australian & New Zealand Children's Haematology/Oncology Group | C17 Council, Children's Cancer Institute Australia (CCIA), Day One Biopharmaceuticals, Inc., Kazia Therapeutics Limited, Medical Research Future Fund, The Hospital for Sick Children |
Australia, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants treated with molecularly-targeted agents in each treatment arm. | Number of CAYA participants (children, adolescents and young adults) with advanced solid tumours (including CNS tumors and non-Hodgkin lymphomas) where molecular sequencing data was used to allocate treatment arms of molecularly-targeted agents. | 5 Years | |
Primary | Recommended phase II dose for each treatment arm | Recommended phase II dose of a novel single agent or combination treatment in CAYA participants, determined by dose-limiting toxicities reported as per CTCAE V5.0. | 3 Years | |
Primary | Objective Response Rate (ORR) for each treatment arm. | ORR defined as complete response and partial response, as measured by RECIST, RAPNO, INRC or RECIL in CAYA participants treated with molecularly-targeted agents. | 5 Years | |
Secondary | Overall Clinical Benefit Rate (CBR) for each treatment arm | CBR defined as complete response and partial response and stable disease, as measured by RECIST, RAPNO, INRC or RECIL in CAYA participants treated with molecularly-targeted agents. | 5 Years | |
Secondary | Progression Free Survival (PFS) for each treatment arm. | PFS in CAYA participants from initiation of treatment with molecularly-targeted agents to the occurrence of disease progression, as measured by RECIST, RAPNO, INRC or RECIL, or death. | 5 Years | |
Secondary | Incidence of treatment-emergent adverse events for each treatment arm. | Safety and tolerability of molecularly-targeted agents as measured by incidence of treatment-emergent adverse events reported as per CTCAE V5.0 in CAYA participants. | 5 Years | |
Secondary | Maximum Concentration (Cmax) of molecularly-targeted agents for each treatment arm. | Cmax in plasma after the first dose of molecularly-targeted agents in CAYA participants. | 5 Years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT04202094 -
Fertility in Young Adults Who Did (Not) Store Testicular Tissue Before a Treatment Leading to Fertility Problems
|
N/A | |
Active, not recruiting |
NCT03336931 -
PRecISion Medicine for Children With Cancer
|
||
Not yet recruiting |
NCT05048771 -
Fertility and Temporality in Pediatric Oncology
|
||
Completed |
NCT05982379 -
Motivation Program for Children With Cancer
|
N/A | |
Completed |
NCT04066218 -
Sexual Function Screening in Childhood Cancer Survivors
|
||
Completed |
NCT03934060 -
Strength Training and ADLs in Childhood Leukemia and Lymphoma Patients
|
N/A | |
Active, not recruiting |
NCT03938324 -
Peer i-Coaching for Activated Self-Management Optimization in Adolescents and Young Adults With Chronic Conditions
|
N/A | |
Active, not recruiting |
NCT04032743 -
Risk Factors and Treatment Outcome of Oncology Children Hospitalized in the Intensive Care Unit Due to Sepsis
|
||
Active, not recruiting |
NCT04328350 -
Social Experiences of Adolescents and Young Adults With Cancer
|
||
Not yet recruiting |
NCT05457153 -
Technology-Based Well-Being Process Program (WEBEPROP) for Children and Adolescents in Palliative Care
|
N/A | |
Recruiting |
NCT05641961 -
Mobile App to Help Survivors of Childhood Cancer Navigate Long-Term Follow-Up Care
|
N/A | |
Completed |
NCT06179914 -
Resilience Models in Adolescence and Youth With Cancer in Taiwan
|
||
Completed |
NCT03951246 -
Cognitive and Motor Training in Pediatric Posterior Fossa Tumor Survivors
|
N/A | |
Not yet recruiting |
NCT04902313 -
Cultivating Resilience in Oncology Practice
|
N/A | |
Completed |
NCT03160768 -
Feasibility of Isolating P16 Expression
|
||
Recruiting |
NCT06053268 -
Mindfulness Interventions to Improve Health Activation, Coping, and Stress Among Childhood Cancer Survivors
|
N/A | |
Recruiting |
NCT06411704 -
Remote Exercise Video Adaptations to Maximize Physical Activity in Childhood Cancer
|
||
Withdrawn |
NCT02130934 -
Cardiac 3D MRI in Pediatric Cancer Patients
|
N/A | |
Completed |
NCT02216604 -
Exercise in Pediatric Cancer Patient Undergoing Anti-Cancer Treatment
|
N/A | |
Recruiting |
NCT03852758 -
Green Exercise for Cancer - Creating Opportunities for Survivors
|
N/A |