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Embryonal Tumor With Multilayered Rosettes

ConditionsEmbryonal Tumor With Multilayered RosettesEmbryonal Tumor With Multilayered Rosettes, Nos
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of California, San Francisco

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 approved by the study chairs prior to enrollment.

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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/Surgery

    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/Surgery

    Tumor tissue will be collected for correlative studies

  • Blood Sample

    Procedure/Surgery

    Blood samples will be collected for correlative studies

  • Cerebrospinal Fluid (CSF) Sample

    Procedure/Surgery

    CSF samples will be collected for correlative studies

Treatment groups

70 Participants
are divided into 4 treatment groups
Group A: Cohort 1: Gross-total resection, non-metastatic, early radiotherapyExperimental treatment 7 interventions
Group B: Cohort 2: Gross-total resection, non-metastatic, high-dose chemotherapyExperimental treatment 7 interventions
Group C: Cohort 3A: Metastatic or residual disease, early radiotherapyExperimental treatment 7 interventions
Group D: Cohort 3B: Metastatic or residual disease, high-dose chemotherapyExperimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

Median Progression-free survival at 6 months (PFS6) (Cohort 1)

The median PFS6 is defined as the median number of months for participants in Cohort 1 who have remained progression-free from the date of initial surgical resection until 6 months.

Time frame
Up to 6 months

Secondary outcomes

1

Median Progression-free survival at 2 years progression-free survival (PFS)

The median PFS6 is defined as the median number of months for participants by cohort who have remained progression-free from the date of initial surgical resection until 2 years post-surgery.

Time frame
Up to 2 years
2

Median Overall Survival at 2 years (OS)

The median OS is defined as the median number of months for participants by cohort who are still alive from the date of initial surgical resection until 2 years post-surgery.

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

Pediatric Neuro-Oncology Consortium

Collaborator

Solving Kids' Cancer

Collaborator

Source ClinicalTrials.gov
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