Clinical trial for Embryonal Tumor With Multilayered Rosettes
Official title Embryonal Tumor With Multilayered Rosettes
ClinicalTrials.gov ID: NCT06861244
What this study is testing
What is Chemotherapy Drug, Cancer - Physician's Choice?
An investigational chemotherapy regimen being studied as a potential treatment for embryonal tumor with multilayered rosettes (ETMR) in children. The drugs in the regimen are designed to kill rapidly dividing cancer cells by interfering with DNA replication or cell division.
Also referred to as Standard of Care, High dose Chemotherapy.
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
- The study aims to learn how well induction chemotherapy, high‑dose chemotherapy, and focal radiation work together and how safe they are for children with newly diagnosed ETMR.
- Who it's for
- Children who have just been diagnosed with embryonal tumor with multilayered rosettes.
- What's involved
- Participants will receive an initial round of chemotherapy, followed by a higher‑dose chemotherapy course, and then targeted radiation therapy. They will have regular clinic visits for the treatments and for monitoring tests such as blood work and imaging.
- Time commitment
- The trial lasts for several months, covering the entire treatment sequence, with multiple visits for therapy administration and follow‑up assessments.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- The eligibility criteria listed below are interpreted literally and cannot be waived.
- Participants must have either a molecularly or histologically confirmed embryonal tumor with multilayered rosettes.
- For enrollment, a confirmation of a minimum of 10-20 unstained formalin-fixed paraffin-embedded (FFPE) slides or 1 block (15-20 mg) with tumor...
- Cohort 1 participants must not have received any prior tumor-directed therapy other than surgical resection.
- Cohort 2 and 3 participants may receive tumor-directed therapy prior to enrollment.
You likely can't join if
- Cohort 1 only: Participants who have received any prior tumor-directed therapy other than surgical intervention
- Participants who are receiving any other tumor directed investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used in study.
- Uncontrolled intercurrent illness.
- Women of childbearing potential must not be pregnant or breast-feeding.
See the full eligibility criteria
- The eligibility criteria listed below are interpreted literally and cannot be waived.
- Participants must have either a molecularly or histologically confirmed embryonal tumor with multilayered rosettes.
- For enrollment, a confirmation of a minimum of 10-20 unstained formalin-fixed paraffin-embedded (FFPE) slides or 1 block (15-20 mg) with tumor content of 40% or greater is required.
- Cohort 1 participants must not have received any prior tumor-directed therapy other than surgical resection.
- Cohort 2 and 3 participants may receive tumor-directed therapy prior to enrollment. These participants must be discussed with study chairs prior to enrollment.
- Participants must not have received prior radiation for treatment of tumor.
- Participants of any age are eligible.
- Participants should begin induction chemotherapy within 28 days of the most recent definitive surgical procedure. Participants beginning therapy beyond 28 days from surgery, will need to discuss with study chairs.
- Cohort specific eligibility
- Cohort 1: Gross-total resection, Eligible for early radiotherapy (please see age criteria below), and no evidence of metastatic disease.
- Cohort 2: Gross-total resection, high dose chemotherapy (please see age criteria below), and no evidence of metastatic disease.
- Cohort 3A: Metastatic or residual disease, and early radiotherapy.
- Cohort 3B: Metastatic or residual disease, and high dose chemotherapy.
- Radiotherapy Age Criteria (at the time of planned radiation): \>12 months of age for participants with infratentorial tumor OR \>15 months of age for participants with supratentorial tumor.
- Performance Score: Karnofsky \>= 50 for participants \> 16 years of age and Lansky \>= 50 for participants \<=16 years of age.
- Peripheral absolute neutrophil count (ANC) \> 75,000/mm3
- Platelet count \> 75,000/mm3 (transfusion independent, defined as not receiving platelet transfusions for at least 72 hours prior to enrollment).
- Adequate Renal Function defined as: a. Serum creatinine \< 1.5 x upper limit normal (ULN) based on age and gender.
- Total bilirubin \< 1.5 x upper limit of normal (ULN) for age; in presence of Gilbert's syndrome, total bilirubin \< 3 x ULN or direct bilirubin \< 1.5 x ULN,
- alanine aminotransferase (ALT) \< 3 x ULN,
- aspartate aminotransferase (AST) \< 3 x ULN,
- Adequate Neurologic Function defined as: a. Participants with seizure disorder may be enrolled if well controlled. Participants on enzyme inducing anticonvulsants may be excluded pending interaction(s) with study drugs.
- As chemotherapeutic agents used in this trial are known to be teratogenic, women and men of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control
- Participants must be enrolled on PNOC COMP prior to enrollment on PNOC031 if PNOC COMP is open to accrual at the enrolling institution.
- A legal parent/guardian or patient must be able to understand, and willing to sign, a written informed consent and assent document, as appropriate.
- Cohort 1 only: Participants who have received any prior tumor-directed therapy other than surgical intervention
- Participants who are receiving any other tumor directed investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used in study.
- Uncontrolled intercurrent illness.
- Women of childbearing potential must not be pregnant or breast-feeding.
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- San Francisco, California, United States
- Indianapolis, Indiana, United States
- Baltimore, Maryland, United States
- St Louis, Missouri, United States
- Hackensack, New Jersey, United States
- Memphis, Tennessee, United States
- Salt Lake City, Utah, United States
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, but confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; San Francisco, California, United States; Indianapolis, Indiana, United States; Baltimore, Maryland, United States; St Louis, Missouri, United States; Hackensack, New Jersey, United States and 2 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.