RECRUITING

Embryonal Tumor With Multilayered Rosettes

Conditions

Embryonal Tumor With Multilayered Rosettes Embryonal Tumor With Multilayered Rosettes, Nos

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

PNOC031: Protocol for Embryonal Tumor With Multilayered Rosettes (ETMR)

Quick Facts

Study Start:2025-03-06

Study Completion:2032-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06861244

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Participants must have either a molecularly or histologically confirmed embryonal tumor with multilayered rosettes. 2. 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 approved by the study chairs prior to enrollment. 3. Prior Therapy: 1. Cohort 1 participants must not have received any prior tumor-directed therapy other than surgical resection. 2. Cohort 2 and 3 participants may receive tumor-directed therapy prior to enrollment. These participants must be discussed with study chairs prior to enrollment. 4. Participants must not have received prior radiation for treatment of tumor. 5. Participants of any age are eligible. 6. 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. 7. Cohort specific eligibility 1. Cohort 1: Gross-total resection, Eligible for early radiotherapy (please see age criteria below), and no evidence of metastatic disease. 2. Cohort 2: Gross-total resection, high dose chemotherapy (please see age criteria below), and no evidence of metastatic disease. 3. Cohort 3A: Metastatic or residual disease, and early radiotherapy. 4. Cohort 3B: Metastatic or residual disease, and high dose chemotherapy. 5. 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 treated on radiotherapy-containing arms, the legal parent/guardian or patient and the physician must be willing to allow the use of radiotherapy for treatment. 8. 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, will be considered ambulatory for the purpose of assessing the performance score. 9. Organ Function Requirements: 1. Peripheral absolute neutrophil count (ANC) \> 75,000/mm3 2. Platelet count \> 75,000/mm3 (transfusion independent, defined as not receiving platelet transfusions for at least 72 hours prior to enrollment). 10. Adequate Renal Function defined as: 11. Adequate Liver Function defined as: 1. 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, 2. alanine aminotransferase (ALT) \< 3 x ULN, 3. aspartate aminotransferase (AST) \< 3 x ULN, 12. Adequate Neurologic Function defined as: 13. 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) prior to study entry, for the duration of study participation and 4 months after completion of study therapy. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. 14. Participants must be enrolled on PNOC COMP prior to enrollment on PNOC031 if PNOC COMP is open to accrual at the enrolling institution. 15. A legal parent/guardian or patient must be able to understand, and willing to sign, a written informed consent and assent document, as appropriate. 1. Cohort 1 only: Participants who have received any prior tumor-directed therapy other than surgical intervention 2. Participants who are receiving any other tumor directed investigational agents. 3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used in study. 4. Uncontrolled intercurrent illness. 5. Women of childbearing potential must not be pregnant or breast-feeding.	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion Criteria

1. Participants must have either a molecularly or histologically confirmed embryonal tumor with multilayered rosettes.
2. 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 approved by the study chairs prior to enrollment.
3. Prior Therapy:
1. Cohort 1 participants must not have received any prior tumor-directed therapy other than surgical resection.
2. Cohort 2 and 3 participants may receive tumor-directed therapy prior to enrollment. These participants must be discussed with study chairs prior to enrollment.
4. Participants must not have received prior radiation for treatment of tumor.
5. Participants of any age are eligible.
6. 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.
7. Cohort specific eligibility
1. Cohort 1: Gross-total resection, Eligible for early radiotherapy (please see age criteria below), and no evidence of metastatic disease.
2. Cohort 2: Gross-total resection, high dose chemotherapy (please see age criteria below), and no evidence of metastatic disease.
3. Cohort 3A: Metastatic or residual disease, and early radiotherapy.
4. Cohort 3B: Metastatic or residual disease, and high dose chemotherapy.
5. 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 treated on radiotherapy-containing arms, the legal parent/guardian or patient and the physician must be willing to allow the use of radiotherapy for treatment.
8. 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, will be considered ambulatory for the purpose of assessing the performance score.
9. Organ Function Requirements:
1. Peripheral absolute neutrophil count (ANC) \> 75,000/mm3
2. Platelet count \> 75,000/mm3 (transfusion independent, defined as not receiving platelet transfusions for at least 72 hours prior to enrollment).
10. Adequate Renal Function defined as:
11. Adequate Liver Function defined as:
1. 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,
2. alanine aminotransferase (ALT) \< 3 x ULN,
3. aspartate aminotransferase (AST) \< 3 x ULN,
12. Adequate Neurologic Function defined as:
13. 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) prior to study entry, for the duration of study participation and 4 months after completion of study therapy. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
14. Participants must be enrolled on PNOC COMP prior to enrollment on PNOC031 if PNOC COMP is open to accrual at the enrolling institution.
15. A legal parent/guardian or patient must be able to understand, and willing to sign, a written informed consent and assent document, as appropriate.
1. Cohort 1 only: Participants who have received any prior tumor-directed therapy other than surgical intervention
2. Participants who are receiving any other tumor directed investigational agents.
3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used in study.
4. Uncontrolled intercurrent illness.
5. Women of childbearing potential must not be pregnant or breast-feeding.

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Contact

PNOC Operations

CONTACT

415-502-1600

PNOC031@ucsf.edu

Principal Investigator

Sabine Mueller, MD, PhD, MAS

PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Derek Hanson, MD

STUDY_CHAIR

Hackensack Meridian Health

Study Locations (Sites)

University of California, San Francisco

San Francisco, California, 94143

United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

Sabine Mueller, MD, PhD, MAS, PRINCIPAL_INVESTIGATOR, University of California, San Francisco
Derek Hanson, MD, STUDY_CHAIR, Hackensack Meridian Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-06

Study Completion Date2032-03-31

Study Record Updates

Study Start Date2025-03-06

Study Completion Date2032-03-31

Terms related to this study

Additional Relevant MeSH Terms

Embryonal Tumor With Multilayered Rosettes
Embryonal Tumor With Multilayered Rosettes, Nos