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New treatment option 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?
Chemotherapy Drug, Cancer - Physician's Choice is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for embryonal tumor with multilayered rosettes.
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
- This is an open-label, comprehensive, iterative investigation of evaluating the use of induction chemotherapy, high-dose chemotherapy, and focal radiation therapy in children with newly diagnosed Embryonal Tumor With Multilayered Rosettes (ETMR).
- 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...
- Prior Therapy:
- Cohort 1 participants must not have received any prior tumor-directed therapy other than surgical resection.
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. Anything less must be discussed and...
- Prior Therapy:
- 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. For participants being...
- Performance Score: Karnofsky \>= 50 for participants \> 16 years of age and Lansky \>= 50 for participants \<=16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair...
- Organ Function Requirements:
- 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.
- Adequate Liver Function defined as:
- 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; abstinence)...
- 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's taking place
- 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 - 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?
Study sites include 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 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.