Vaccine Trial for Children with Low Grade Gliomas
Sponsor: James Felker
ClinicalTrials ID:NCT02358187
This clinical trial is testing a new vaccine to see if it is safe and effective in children with low-grade gliomas, a type of brain tumor, who have already tried at least two other treatments.
Patient Parameters
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Program Overview
The study aims to evaluate the safety and effectiveness of a vaccine made from glioma-associated antigens (GAA) and tetanus toxoid (TT), combined with a substance called poly-ICLC, in children with low-grade gliomas that cannot be surgically removed. These children must have already undergone at least two chemotherapy or biological treatments. Radiation therapy counts as one of these treatments, but they must not have received radiation to the main tumor area within a year before joining the study.
Description
Participants in this study will receive injections of the GAA/TT vaccine under the skin every three weeks, for up to eight cycles, unless they meet criteria to stop treatment earlier. After each vaccine injection, they will also receive an injection of poly-ICLC near the same site. The timing of these injections can be adjusted by up to a week if needed.
The study will monitor participants for any side effects or serious reactions, as well as how their tumors respond to the treatment, through regular clinical visits and MRI scans. Follow-up MRIs will be conducted at weeks 6, 15, and 24 to assess the tumor's response.
Eligibility Criteria
Inclusion Criteria
- Have a type of brain tumor called low-grade glioma that cannot be surgically removed and has been treated with at least two chemotherapy or biological treatments. Radiation therapy counts as one treatment, but no radiation to the main tumor area within a year before joining the study.
- Test positive for HLA-A2, a specific genetic marker.
- Be stable in health and either not taking or on a low dose of corticosteroids (no more than 0.1 mg/kg/day, max 4 mg/day of Dexamethasone) for at least one week before joining the study.
- Be between 12 months and 22 years old at the time of genetic screening.
- Have a performance status score of 70 or higher, indicating they are able to carry out normal activities with some effort.
- Female participants who have started menstruating must have a negative pregnancy test, as the effects of the vaccine on pregnancy are not known.
- Be free of any serious infections requiring IV antibiotics at the time of joining the study and off IV antibiotics for at least 7 days before joining.
- Have adequate organ function, including specific blood cell counts and liver and kidney function.
- Have recovered from any side effects of previous treatments to a mild level or better and be at least 3 weeks from the last dose of standard chemotherapy or myelosuppressive biological therapy, and at least 1 week from the last dose of non-myelosuppressive biological therapy.
- No serious heart, stomach, lung, or mental health conditions.
Exclusion Criteria
- Living outside of North America.
- Have received radiation to the main tumor area within a year before joining the study.
- Currently receiving or have recently received (within one week) certain treatments or medications, including:
- Interferon
- Allergy desensitization shots
- Growth factors
- Interleukins
- Any experimental medications
- Have a history of or currently active autoimmune disorders requiring strong medications or affecting internal organs.
- Have used immunosuppressive medications within four weeks before joining the study or plan to use them. Corticosteroids, if used around surgery, must be reduced to no more than 0.1 mg/kg/day, max 4 mg/day of dexamethasone for at least one week before joining. Topical corticosteroids are allowed.
- HIV-positive patients are excluded as they may not respond to the treatment.
- Have received prior immunotherapy.
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