Trial NCT04943848
rHSC-DIPGVax Plus Checkpoint Blockade for the Treatment of Newly Diagnosed DIPG and DMG
- Phase
- Phase 1
- Sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Conditions
- Diffuse Intrinsic Pontine Glioma; Diffuse Midline Glioma, H3 K27M-Mutant
- Ages
- 1–18 years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
Inclusion Criteria:
* Subjects with newly diagnosed typical or non-typical, biopsy-proven DIPG or DMG are eligible for study enrollment. Biopsy is not required for subjects with radiographically typical DIPG meeting imaging criteria. Biopsy is required for DMG's and non-radiographically typical DIPG. Histone mutation must be confirmed by pathology report. Radiographically typical DIPG defined as a tumor with a pontine epicenter and diffuse involvement of more than 2/3 of the pons.
= Subjects ages > or = to 12 months and < or = 18 yearsAge ("Lead In", Part A, and Part B require first three patients be > or = to 12 years of age)
* BSA > or = 0.35m2 at the time of study enrollment
* Performance score: Karnofsky >50% of subjects >16 years of age and Lansky > or = 50 for subjects < or = 16 years of age.Performance status Subjects who are unable to walk because of paralysis but are up in a wheelchair will be considered ambulatory for the purpose of assessing the performance score.
* Must start radiation therapy within 42 days from date of diagnostic imaging. C1D1 must be within 42 days to 70 days post radiation (6-10 weeks). Patients CANNOT receive temozolomide during radiation
* Corticosteroids should be weaned as tolerated after radiation therapy with the goal of < or = 0.5mg/kg/day for a minimum of 7 days prior to enrollment.
* Subjects must have measurable disease
Exclusion Criteria:
* Patients cannot receive temozolomide during radiation
* Disseminated disease
* Subjects who have received any cancer therapy except for radiation
* Autoimmune or immune disorders
* Active respiratory disorder or infection
* Active viral infection
Restrictions found (2)
- AgeOutrightinclusion
age <= 18 years
Show in the text - Performance statusOutrightinclusion
Karnofsky > 50%
Show in the text
Recruiting in Massachusetts
- Dana-Farber Boston Children's Cancer and Blood Disorders Center · Boston, Suffolk County