a study on Glioma
This is a two cohort Phase I study within the Pacific Pediatric Neuro-Oncology Consortium (PNOC). This study will assess the safety of repeated administration of the H3.3K27M specific vaccine in HLA-A2+ children and young adults with H3.3K27M DIPGs and other gliomas.
H3.3K27M Specific Peptide Vaccine Combined With Poly-ICLC for the Treatment of Newly Diagnosed HLA-A2+ H3.3K27M Positive Diffuse Intrinsic Pontine Glioma (DIPG) as Well as Other Newly Diagnosed HLA-A2+ H3.3K27M Positive Gliomas
Subjects who are eligible will receive a specific peptide vaccine, along with a helper drug called poly-ICLC, every 3 weeks for the first 6 months of treatment. Subjects will be monitored routinely by laboratory assessments, physical evaluation, vital signs, and MRI. Subjects who tolerate therapy well and have stable or improved disease after 6 months of treatment can continue to receive treatment, now every 6 weeks, for a total of 96 weeks of treatment.
Diffuse Intrinsic Pontine Glioma Glioma peptide vaccine immunotherapy DIPG vaccine Vaccines Poly ICLC
Open to people ages 3–21
• Newly diagnosed children (3-21 years old) with diagnosis of glioma other than DIPG who are positive for the H3.3K27M mutation (positive testing in CLIA laboratory) including spinal cord gliomas that underwent standard radiation therapy.
The following eligibility criteria apply to both Stratum A and B.
Patients must have undergone radiation therapy and surgery as part of their standard of care.
o Radiation therapy must have started within 28 days of diagnosis by imaging or surgery, whichever is later.
Adequate Bone Marrow Function Defined as:
Adequate Renal Function Defined as:
A serum creatinine based on age/gender as follows:
Age Maximum Serum Creatinine (mg/dL) Male Female
6 to < 10 years 1 1 10 to < 13 years 1.2 1.2 13 to < 16 years 1.5 1.4 The threshold creatinine values in this table were derived from the Schwartz formula for estimating GFR utilizing child length and stature data published by the CDC.
Adequate Liver Function Defined as:
Adequate Neurologic Function Defined as:
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
The study team should get back to you in a few business days.
You will also receive an email with next steps. Check your junk/spam folder if needed.
If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT02960230.
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