Summary

for people ages up to 21 years (full criteria)
at San Francisco, California
study started
estimated completion:
Sabine Mueller

Description

Summary

This is a 2 strata pilot trial within the Pacific Pediatric Neuro-Oncology Consortium (PNOC). The study will use a new treatment approach based on each patient's tumor gene expression, whole-exome sequencing (WES), whole-genome sequencing (WGS), targeted panel profile (UCSF 500 gene panel), quantitative proteomics, and RNA-Seq. The current study will test the efficacy of such an approach in children with High-grade gliomas HGG.

Official Title

A Pilot Trial Testing the Clinical Benefit of Using Molecular Profiling to Determine an Individualized Treatment Plan in Children and Young Adults With High Grade Glioma (Excluding Diffuse Intrinsic Pontine Glioma)

Details

For children with High-grade gliomas (HGG) including HGG presenting within the midline structures of the brain and spine, outcome remains poor and the majority of children die from this disease. The current study will use a new treatment approach based on each patient's tumor gene expression, whole-exome sequencing (WES), whole-genome sequencing (WGS), targeted panel profile (UCSF 500 gene panel), quantitative proteomics, and RNA-Seq. This treatment strategy has shown promising results in adult patients with solid tumors and is currently being explored in children with DIPG, neuroblastoma and other solid tumors. The current study will test the efficacy of such an approach in children with HGG for which outcomes remain dismal.

Keywords

Glioma Glioma of Brain Cancer Pediatric Cancer Pediatric Brain Tumor Astrocytoma Glioblastoma Hemispheric High-grade glioma whole genome sequencing WGS whole exome sequencing WES genomics RNA sequencing Specialized tumor board recommendation

Eligibility

You can join if…

Open to people ages up to 21 years

  • Patients with newly diagnosed HGG (including midline HGG but excluding DIPG), who undergo tissue collection as part of standard of care. Patients with disseminated disease are not eligible, and MRI of the spine must be performed if disseminated disease is suspected by the treating physician. Primary spinal cord tumors are eligible.
  • Enrollment within 3 weeks of the start of radiation therapy.
  • Start of radiation therapy within 6 weeks from initial tissue diagnosis.
  • Age ≤ 21 years
  • Karnofsky score ≥ 50 for patients ≥ 16 years of age and Lansky score ≥ 50 for patients≤15 years of age. Patients 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
  • Adequate tissue for molecular profiling (>25% tumor content).
  • The effects of the current treatment paradigm on the developing human fetus are unknown. For this reason, females of child-bearing potential and males must agree to use adequate contraception: hormonal or barrier method of birth control; abstinence prior to study entry and for the duration of study participation, and 30 days after completion of study drug administration. Should a female become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Males treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 30 days after completion of study drug administration.
  • Adequate neurologic function defined as: Patients with seizure disorder may be enrolled if seizures are well controlled.
  • Ability by patient or parent/legal guardian to understand a written informed consent document, and the willingness to sign it.

You CAN'T join if...

  • Patients who are currently enrolled on another therapeutic clinical trial. Individual cases should be discussed with the study chair.
  • Patients who are currently taking any anti-cancer directed therapy. Steroids are not considered anti-cancer therapy. The use of temozolomide during radiation therapy is allowed at standard dosing (maximum 75 to 90 mg/m2 daily for a total of 42 days). Any other schedule(s) need to be discussed with the study chair.

  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Female patients of childbearing potential must not be pregnant or breast-feeding.Female patients of childbearing potential must have a negative serum or urine pregnancy test prior to the start of therapy (as clinically indicated).
  • Patients with inability to return for follow-up visits or obtain follow-up studies required to assess toxicity to therapy.

Location

  • University of California, San Francisco accepting new patients
    San Francisco California 94158 United States

Lead Scientist

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03739372
Study Type
Interventional
Last Updated