Embryonal Tumor With Multilayered Rosettes

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of California, San Francisco
Study ID
NCT06861244
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Radiotherapy (RT) — RADIATION
    Undergo RT
  • Chemotherapy Drug, Cancer - Physician's Choice — DRUG
    One or more of the following may be assigned by the physician (physician's choice) per standard of care guidelines upon study enrollment following surgery: Cytarabine, Carboplatin, Cisplatin, Vincristine Sulfate injection (Vincristine PFS), Topotecan Hydrochloride, Dactinomycin, Thiotepa, Filgrastim, Cyclophosphamide, or Doxorubicin Hydrochloride. Not all participants will receive all possible drug regimens.
  • Non-Investigational Surgical Resection — PROCEDURE
    Undergo surgery directly before study enrollment as part of planned care.
  • Temozolomide — DRUG
    Participants assigned to or whom receive optional RT will receive concurrent temozolomide
  • Tumor Tissue Sample — PROCEDURE
    Tumor tissue will be collected for correlative studies
  • Blood Sample — PROCEDURE
    Blood samples will be collected for correlative studies
  • Cerebrospinal Fluid (CSF) Sample — PROCEDURE
    CSF samples will be collected for correlative studies

Study Details

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).

Key Dates

Start date
Mar 6, 2025
Status verified
Apr 2026
Primary completion
Sep 30, 2030
Completion
Mar 31, 2032

Study Design

Enrollment
70 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: Gross-total resection, non-metastatic, early radiotherapy
    Participants will undergo gross total resection of the tumor prior to enrollment into this cohort. Standard dose induction chemotherapy and 6-weeks of early focal radiotherapy, followed by and a second standard dose induction chemotherapy for a total of 12 weeks of chemotherapy; 18 weeks of treatments in all. Participants will be followed for up to 2 years.
  • Experimental: Cohort 2: Gross-total resection, non-metastatic, high-dose chemotherapy
    Participants will undergo gross total resection of the tumor prior to enrollment into this cohort. Participants will receive 6 weeks of induction chemotherapy and 3 cycles (approximately 4 weeks each) of high-dose chemotherapy with stem cell rescue and will have the option to receive radiotherapy at the completion of therapy, for a total of 18-24 weeks. Participants will be followed for up to 2 years.
  • Experimental: Cohort 3A: Metastatic or residual disease, early radiotherapy
    Participants metastatic disease or residual disease following their initial surgical interventions prior to enrollment into this cohort will receive standard dose induction chemotherapy and 6-weeks of early focal radiotherapy, followed by and a second standard dose induction chemotherapy for a total of 12 weeks of chemotherapy; 18 weeks of treatments in all. Participants will be followed for up to 5 years.
  • Experimental: Cohort 3B: Metastatic or residual disease, high-dose chemotherapy
    Participants metastatic disease or residual disease following their initial surgical interventions prior to enrollment into this cohort. Participants will receive 6 weeks of induction chemotherapy and 3 cycles (approximately 4 weeks each) of high-dose chemotherapy with stem cell rescue and will have the option to receive radiotherapy at the completion of therapy, for a total of 18-24 weeks. Participants will be followed for up to 5 years.

Primary Outcome Measure

Median Progression-free survival at 6 months (PFS6) (Cohort 1) [ Time Frame: Up to 6 months ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233
Girish Dhall, MD
[email protected]
205-638-6194
Laura K Metrock, MD
[email protected]
205-638-9285
University of California, San FranciscoSan FranciscoCalifornia94143
PNOC Operations Office
[email protected]
415-502-1600
[email protected]
877-827-3222
Sabine Mueller, MD, Phd, MAS (PRINCIPAL_INVESTIGATOR)
Riley Hospital for Children at Indiana University HealthIndianapolisIndiana46202
Brian Weiss, MD
[email protected]
317-944-8784
Alex Lion, DO
[email protected]
317-944-8784
Johns Hopkins UniversityBaltimoreMaryland21218
Kenneth Cohen, MD, MBA
[email protected]
410-614-5055
Robyn Gartrell, MD, MS
[email protected]
410-955-2548
Washington University in St. LouisSt LouisMissouri63130
Michael Angelo Huang, MD
[email protected]
314-362-4563
Mohamed AbdelBaki, MD
[email protected]
(314) 454-6018
Hackensack University Medical CenterHackensackNew Jersey07601
Derek Hanson, MD
[email protected]
551-996-5437
Katharine Offer, MD
[email protected]
551-996-5437
St. Jude Children's Research HospitalMemphisTennessee38105
Emily Hanzlik, MD
[email protected]
901-595-2615
Amar Gajjar, MD
[email protected]
901-595-2615

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