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New treatment option for CNS Embryonal Tumor
Official title Pilot Study of IT Topotecan and Maintenance Chemotherapy for HR-EBTs in Children < 6 Years, Post Consolidation
ClinicalTrials.gov ID: NCT06942039
What this study is testing
What is Cytarabine IT?
Cytarabine IT is an investigational medicine, given as a monthly pill taken by mouth, being studied as a potential treatment for cns embryonal tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Pilot study to determine feasibility of adding intrathecal chemotherapy and maintenance therapy after high dose chemotherapy for treatment of newly diagnosed HR-EBTs in patients less than 6 years of age.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 6
You may be able to join if
- Tumor Tissue Sample
- Age: Patient must be aged ≥ 0 years to ≤ 6 years at the time of definitive confirmation of histologic diagnosis of eligible CNS tumor.
- Diagnoses. Participants must have Central nervous system (CNS) HR-EBT including atypical teratoid rhabdoid tumour (ATRT), group 3 and group 4...
- Cranial and Spine MRI. A baseline MRI brain and spine with and without contrast is required for all patients. cranial MRI (with and without...
- Lumbar Puncture (LP) CSF for cytopathology (strongly recommended but not mandatory; if medically feasible). A baseline LP CSF cytology either...
You likely can't join if
- Patients who are receiving any other conventional anti-cancer agents or investigational agents.
- Patients who received previous therapy including radiotherapy or chemotherapy other than corticosteroids.
- Presence of another malignancy, except if the other primary malignancy is neither currently clinically significant nor requiring active intervention.
- Concomitant medications restrictions: Concurrent use of enzyme inducing anticonvulsants (e.g. phenytoin, phenobarbital, and carbamazepine), selected...
- Other uncontrollable medical disease: Patient has a severe and uncontrollable medical disease (i.e., uncontrolled diabetes, hyperglycemia, chronic...
- Patients who have a known diagnosis of human immunodeficiency virus (HIV) infection, hepatitis B or C.
See the full eligibility criteria
- Tumor Tissue Sample
- Age: Patient must be aged ≥ 0 years to ≤ 6 years at the time of definitive confirmation of histologic diagnosis of eligible CNS tumor.
- Diagnoses. Participants must have Central nervous system (CNS) HR-EBT including atypical teratoid rhabdoid tumour (ATRT), group 3 and group 4 medulloblastoma (MB), pineoblastoma, CNS neuroblastoma, embryonal tumor with...
- Cranial and Spine MRI. A baseline MRI brain and spine with and without contrast is required for all patients. cranial MRI (with and without gadolinium) must be done pre-operatively. Post-operatively, cranial MRI (with...
- Lumbar Puncture (LP) CSF for cytopathology (strongly recommended but not mandatory; if medically feasible). A baseline LP CSF cytology either pre-operatively or post-operatively at least 10 days after definitive surgery...
- Life expectancy: Patients must have a life expectancy of greater than 8 weeks from diagnosis.
- Performance level: Patients must have a performance status corresponding of a Lansky score ≥ 50.
- Organ Function Requirements: Participants must have normal organ and marrow function as defined below: Adequate renal function defined as: \- Creatinine clearance (12-24-hour urine collection) or radioisotope glomerular...
- Shortening fraction of ≥ 27% by echocardiogram, or
- Ejection fraction of ≥ 47% by radionuclide angiogram. Adequate pulmonary function defined as: \- No evidence of dyspnea at rest and a pulse oximetry \> 94% on room air. Adequate Bone Marrow Function defined as:
- Peripheral absolute neutrophil count (ANC) \> 1000/μL
- Platelet Count \> 100,000/μL (without transfusion for 3 days)
- Hemoglobin greater than 8 gm/dL (may have received red blood cell (RBC) transfusions) Adequate liver function defined as:
- Total bilirubin ≤ 1.5X upper limit of normal (ULN) within normal institutional limits for age (patients with documented Gilbert's Disease may be enrolled with Study Chair approval and total bilirubin ≤ 2.0 × ULN)
- Alanine Aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 100 U/L
- Patients who are receiving any other conventional anti-cancer agents or investigational agents.
- Patients who received previous therapy including radiotherapy or chemotherapy other than corticosteroids.
- Presence of another malignancy, except if the other primary malignancy is neither currently clinically significant nor requiring active intervention.
- Concomitant medications restrictions: Concurrent use of enzyme inducing anticonvulsants (e.g. phenytoin, phenobarbital, and carbamazepine), selected strong inhibitors of cytochrome P450 3A4 include azole antifungals...
- Other uncontrollable medical disease: Patient has a severe and uncontrollable medical disease (i.e., uncontrolled diabetes, hyperglycemia, chronic renal disease or active uncontrolled infection), has chronic liver...
- Patients who have a known diagnosis of human immunodeficiency virus (HIV) infection, hepatitis B or C.
- Ineligible diagnoses for study entry by neuropathology: This includes sonic hedgehog (SHH) and wingless (WNT) MBs, all ependymomas, all choroid plexus carcinomas, all high grade glial and glio-neuronal tumors, all...
- The participant or parent(s)/guardian(s) cannot comply with the study visit schedule and other protocol requirements, in the investigator's opinion. All patients must meet inclusion/exclusion criteria prior to starting...
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
- Vancouver, British Columbia, Canada
- Winnipeg, Manitoba, Canada
- Halifax, Nova Scotia, Canada
- Hamilton, Ontario, Canada
- London, Ontario, Canada
- Montreal, Quebec, Canada
- Québec, Quebec, Canada
- Sherbrooke, Quebec, Canada
- Edmonton, Canada
- Toronto, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 6 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada; Vancouver, British Columbia, Canada; Winnipeg, Manitoba, Canada; Halifax, Nova Scotia, Canada; Hamilton, Ontario, Canada; London, Ontario, Canada and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.