A Vaccine Trial for Low Grade Gliomas
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|ClinicalTrials.gov Identifier: NCT02358187|
Recruitment Status : Recruiting
First Posted : February 6, 2015
Last Update Posted : January 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Low Grade Glioma||Biological: Experimental: HLA-A2 Restricted Glioma Antigen-Peptides with Poly-ICLC||Phase 2|
Patients will be treated with subcutaneous injections of GAA/TT-vaccines starting on Week 0 and every 3 weeks thereafter for up to 8 cycles or until Off-treatment criteria are met (Section 4.6). I.m. poly-ICLC will be administered (30ug/kg i.m.) immediately following the vaccine. Poly-ICLC should be administered i.m. within 3 cm of the peptide-injection site.
To allow for flexibility with scheduling, the peptide vaccine and Poly-ICLC dose may be given within one week of the date that the vaccine and poly-ICLC administration are due.
Patients will be evaluated for any possible adverse event, regimen limiting toxicity (RLT) as well as clinical/radiological responses by clinical visits and MRI scanning. Follow-up MRIs will be performed (Weeks 6, 15 and 24).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Vaccinations With HLA-A2 Restricted Glioma Antigen Peptides in Combination With Poly-ICLC for Children With Recurrent Unresectable Low-Grade Gliomas (LGG)|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
Experimental: HLA-A2 Restricted Glioma Antigen-Peptides with Poly-ICLC
All subjects will receive vaccine plus Poly-ICLC. Injections will be given every 3 week for a total of 8 vaccines.
Biological: Experimental: HLA-A2 Restricted Glioma Antigen-Peptides with Poly-ICLC
Poly-ICLC is administered intramuscularly (i.m.) using sterile technique, as supplied from the vial, and in the amount prescribed for the participant's weight. Patients should receive a dose of acetaminophen (15 mg/kg up to a max of 1000 mg) 30-60 minutes before each poly-ICLC administration. The poly-ICLC treatments will be administered immediately following the vaccine. Patients/parents will be asked to report any temperature elevations and side effects after each treatment.
- Tumor shrinkage or stable disease [ Time Frame: Week 24 ]Participants who demonstrate radiological evidence of tumor shrinkage or stable disease without regimen-limiting toxicity (RLT) after the initial 8 vaccines will be eligible to receive additional vaccinations beginning week 24 and every 6 weeks thereafter for up to two years.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02358187
|Contact: Alberto Broniscer, MD||412 692-5055|
|Contact: Carole Rimer, RN||412 firstname.lastname@example.org|
|United States, Pennsylvania|
|Children's Hospital of Pittsburgh of UPMC||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15224|
|Contact: Carole Rimer, RN 412-692-7336 email@example.com|
|Principal Investigator:||Alberto Broniscer, MD||Children's Hospital of Pittsburgh of UPMC|