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Early Phase 1Recruiting

Testing Cytarabine IT with hydrocortisone for CNS embryonal tumor

Official title: Pilot Study of IT Topotecan and Maintenance Chemotherapy for HR-EBTs in Children < 6 Years, Post Consolidation

A Pilot Study of Intrathecal Topotecan and Maintenance Chemotherapy in the Post-consolidation Setting for the Treatment of High-risk Embryonal Central Nervous System Tumours in Children Less Than 6 Years of Age

Condition: CNS Embryonal TumorSponsor: C17 CouncilTarget enrollment: 15

Early Phase 1
1 group
Sites in Edmonton, Toronto and 9 more cities
Recruiting

Interventions (16)

Medication
Cytarabine IT
Age-based dosing as a part of double IT therapy (cytarabine, hydrocortisone) during induction (3 cycles, 1 cycle = 21 days) alongside CISplatin, vinCRIStine, etoposide, cyclophosphamide, mesna and filgrastim (G-CSF).
Medication
hydrocortisone
Double IT therapy (cytarabine, hydrocortisone) during induction (3 cycles, 1 cycle = 21 days) alongside CISplatin, vinCRIStine, etoposide, cyclophosphamide, mesna and filgrastim (G-CSF).
Medication
Cisplatin
Intravenous CISplatin given on Day 1 during induction (3 cycles, 1 cycle = 21 days) alongside double IT therapy, vinCRIStine, etoposide, cyclophosphamide, mesna and filgrastim (G-CSF).
Medication
Vincristine
Intravenous VinCRIStine given on Days 1, 8 \& 15 during induction (3 cycles, 1 cycle = 21 days) alongside double IT therapy, CISplatin, etoposide, cyclophosphamide, mesna and filgrastim (G-CSF).
Medication
Etoposide
Induction: Intravenous Etoposide given on Days 1, 2 \& 3 during induction (3 cycles, 1 cycle = 21 days) alongside double IT therapy, CISplatin, vinCRIStine, cyclophosphamide, mesna and filgrastim (G-CSF). Maintenance Arm B (for high-risk patients): Oral Etoposide given on Days 1-21 every 9 weeks (max 6 cycles, 1 cycle = 9 weeks) in combination with IT Topotecan, ISOtretinoin, Celecoxib, Cyclophosphamide and Temozolomide.
Medication
Cyclophosphamide
Induction: Intravenous high-dose Cyclophosphamide given on Days 2 \& 3 during induction (3 cycles, 1 cycle = 21 days) alongside double IT therapy, CISplatin, vinCRIStine, etoposide, mesna and filgrastim (G-CSF). Maintenance Arm B (for high-risk patients): Oral Cyclophosphamide given on Days 1-21 every 9 weeks (max 6 cycles, 1 cycle = 9 weeks) in combination with IT Topotecan, ISOtretinoin, Celecoxib, Etoposide and Temozolomide.
Medication
Mesna
Induction: Intravenous Mesna given at hour 0 of Cyclophosphamide delivery and 3, 6, 9 \& 12 hours post-dose during induction (3 cycles, 1 cycle = 21 days).
Medication
Filgrastim
Induction: Subcutaneous or intravenous Filgrastim (G-CSF) given 24-48 hrs after last dose of chemotherapy and/or as per institutional guidelines until count recovery. Consolidation: Subcutaneous or intravenous Filgrastim (G-CSF) given 24-48 hours after last stem cell infusion and/or per institutional guidelienes until count recovery.
Medication
carboplatin
Consolidation: Intravenous Carboplatin given on days -3 \& -2 during consolidation alongside thiotepa and filgrastim.
Medication
Thiotepa
Consolidation: Intravenous Thiotepa given on days -3 \& -2 during consolidation alongside carboplatin and filgrastim.
Medication
Topotecan IT
Maintenance A (for low-risk patients): IT Topotecan on Day 1 of each cycle (max 12 cycles, 1 cycle = 28 days) alongside Tamoxifen and ISOtretinoin. Maintenance B (for high-risk patients): IT Topotecan every 4 weeks (max 6 cycles, 1 cycle = 9 weeks) alongside ISOtretinoin, Celecoxib, Etoposide, Cyclophosphamide and Temozolomide.
Medication
Tamoxifen
Maintenance A (for low-risk patients): Oral Tamoxifen twice daily, Days 1-28 (max 12 cycles, 1 cycle = 28 days) alongside ISOtretinoin and IT Topotecan.
Medication
ISOtretinoin
Maintenance A (for low-risk patients): Oral ISOtretinoin twice daily on Days 15-28 of each cycle (max 12 cycles, 1 cycle = 28 days) alongside Tamoxifen and IT Topotecan. Maintenance B (for high-risk patients): Oral ISOtretinoin twice daily on Days 1-21, every 6 weeks (max 6 cycles, 1 cycle = 9 weeks) alongside IT Topotecan, Celecoxib, Etoposide, Cyclophosphamide and Temozolomide.
Medication
Celecoxib
Maintenance B (for high-risk patients): Oral Celecoxib twice daily on Days 1-21, every 6 weeks (max 6 cycles, 1 cycle = 9 weeks) alongside IT Topotecan, ISOtretinoin, Etoposide, Cyclophosphamide and Temozolomide.
Medication
etoposide phosphate
During Induction and Maintenance B (for high-risk patients), etoposide phosphate may be given for subsequent doses to patients who have experienced etoposide allergic reactions.
Medication
Temozolomide
Maintenance B (for high-risk patients): Oral Temozolomide daily on Days 1-21, every 9 weeks (max 6 cycles, 1 cycle = 9 weeks) alongside IT Topotecan, ISOtretinoin, Etoposide, Cyclophosphamide and Celecoxib.

Canadian Sites (12)

10 of 12 recruiting

Alberta Children's Hospital
Calgary, Alberta
Recruiting
BC Children's Hospital
Vancouver, British Columbia
Recruiting
Stollery Children's Hospital
Edmonton
Recruiting
CancerCare Manitoba (CCMB)
Winnipeg, Manitoba
Recruiting
McMaster Children's Hospital
Hamilton, Ontario
Recruiting
London Health Sciences Centre
London, Ontario
Recruiting
CHU Sainte-Justine
Montreal, Quebec
Recruiting
CHU de Québec-Université Laval
Québec, Quebec
Recruiting
Centre hospitalier universitaire de Sherbrooke (CHUS)
Sherbrooke, Quebec
Recruiting
The Hospital for Sick Children
Toronto
Recruiting
IWK Health Centre
Halifax, Nova Scotia
Not yet recruiting
Montreal Children's Hospital (McGill)
Montreal, Quebec
Not yet recruiting

See who this study is looking for31 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

+\- Creatinine clearance (12-24-hour urine collection) or radioisotope glomerular filtration rate (GFR) ≥ 60 ml/min/1.73m2
+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 multi-layered rosettes (ETMR including embryonal tumor with abundant neuropil and true rosettes (ETANTR), ependymoblastoma and ETMR not otherwise specified), medulloepithelioma, CNS embryonal tumor with rhabdoid features (INI-1 intact) and CNS embryonal tumor, not otherwise specified. Metastatic disease included. Any extent of resection included.
+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 and without gadolinium) must be done.
+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:
+Adequate cardiac function defined as:
+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
+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 for all patients if medically feasible (This is not mandatory and will not make the patient ineligible).

Exclusion

−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 disease (i.e., chronic active hepatitis and cirrhosis), hypercholesterolemia (serum cholesterol \>300 mg/dL), intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, active hyperparathyroidism, or psychiatric illness/social situations that would limit compliance with study requirements.
−Patients who have a known diagnosis of human immunodeficiency virus (HIV) infection, hepatitis B or C.
−Patients who are receiving any other conventional anti-cancer agents or investigational agents.
−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, such as fluconazole, voriconazole, itraconazole, ketoconazole, and strong inducers include drugs such as rifampin, phenytoin, phenobarbitol, carbamazepine, and St. John's wort or CYP450 3A4 stimulators or inhibitors.
−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 diffuse midline gliomas, all primary CNS germ cell tumors, all primary CNS sarcomas, all primary or metastatic CNS lymphomas and solid leukemic lesions (chloromas, granulocytic sarcomas).
−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 any protocol therapy.
−Patients who received previous therapy including radiotherapy or chemotherapy other than corticosteroids.

5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning

What this study is

This study is testing a treatment for a condition.

Early Phase 1 — the earliest human testing, in a very small group, to observe how the body handles it.

From the trial registry

Built from these fields:

designModule.designInfo.primaryPurpose
designModule.phases

Who receives what

Everyone in this study is in one group, which receives one or more of: Cytarabine IT, hydrocortisone, Cisplatin, Vincristine, Etoposide, Cyclophosphamide, Mesna, Filgrastim, carboplatin, Thiotepa, Topotecan IT, Tamoxifen, ISOtretinoin, Celecoxib, etoposide phosphate and Temozolomide.

From the trial registry

Built from these fields:

armsInterventionsModule.armGroups[].label
armsInterventionsModule.armGroups[].type
armsInterventionsModule.armGroups[].interventionNames

How the study is run

There is only one group in this study, so there is no assignment to different treatments.

This study is open-label: everyone knows which treatment is being given, including you and the study team.

From the trial registry

Built from these fields:

designModule.designInfo.allocation
designModule.designInfo.maskingInfo.masking

Is there a placebo?

This study does not list a placebo group.

From the trial registry

Built from these fields:

armsInterventionsModule.armGroups[].type
armsInterventionsModule.armGroups[].interventionNames

Who the study is looking for

The study lists a maximum age of 6 years.

The study is open to people of any sex.

The study does not accept healthy volunteers.

These are the criteria the study lists. Only the trial site can decide whether someone can take part.

From the trial registry

Built from these fields:

eligibilityModule.maximumAge
eligibilityModule.sex
eligibilityModule.healthyVolunteers

How big and how long

The study aims to enrol about 15 people.

The study is currently expected to finish around December 2032.

The main measurement is taken over: At completion of maintenance therapy (approximately 48-54 weeks after start of maintenance therapy).

From the trial registry

Built from these fields:

designModule.enrollmentInfo.count
statusModule.completionDateStruct.date
outcomesModule.primaryOutcomes[].timeFrame

What the study measures

To determine the feasibility of adding intrathecal (IT) topotecan and maintenance therapy after high dose chemotherapy for treatment of newly diagnosed HR-EBTs in patients less than 6 years of age — measured over At completion of maintenance therapy (approximately 48-54 weeks after start of maintenance therapy).

To test the feasibility of centralized diagnostics and national tumour board review for clinical management of HR-EBTs — measured over Within 4 weeks after definitive surgical resection, prior to start of induction chemotherapy.

To establish a national HR infant brain tumor trial platform for future studies — measured over At study completion (anticipated average duration of 2 years per participant).

From the trial registry

Built from these fields:

outcomesModule.primaryOutcomes[].measure
outcomesModule.primaryOutcomes[].timeFrame

Source: NCT06942039 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About Cytarabine ITDrug

Age-based dosing as a part of double IT therapy (cytarabine, hydrocortisone) during induction (3 cycles, 1 cycle = 21 days) alongside CISplatin, vinCRIStine, etoposide, cyclophosphamide, mesna and filgrastim (G-CSF).