Clinical Benefit of Using Molecular Profiling to Determine an Individualized Treatment Plan for P… (NCT03739372) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Clinical Benefit of Using Molecular Profiling to Determine an Individualized Treatment Plan for Patients With High Grade Glioma
United States44 participantsStarted 2018-11-28
Plain-language 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), targeted panel profile (UCSF 500 gene panel), and RNA-Seq. The current study will test the efficacy of such an approach in children with High-grade gliomas HGG.
Who can participate
Age range21 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with newly diagnosed HGG (including midline HGG but excluding DIPG), who undergo tissue collection as part of standard of care. HGG is defined as either World Health Organization (WHO) grade III or IV, or testing positive for H3K27M mutation. 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 (see Section 8 of the protocol for full details)
* 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…
What they're measuring
1
12 month Progression Free Survival (PFS) for Stratum A