Phase I Trial of IDH1 Peptide Vaccine in IDH1R132H-mutated Grade III-IV Gliomas (NOA-16)
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|ClinicalTrials.gov Identifier: NCT02454634|
Recruitment Status : Completed
First Posted : May 27, 2015
Last Update Posted : November 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Glioma||Drug: IDH1 peptide vaccine||Phase 1|
The patient population will be molecularly defined and include IDH1R132H mutant grade III and IV gliomas without co-deletion of 1p/19q and with loss of alpha-thalassemia/mental retardation syndrome X-linked (ATRX) expression.
Within this trial, the IDH1 peptide vaccine will be administered to 39 patients.
In treatment group 1 vaccination treatment will be done alone starting 4-6 weeks post radiotherapy. In treatment groups 2 and 3 vaccination treatment will be done in parallel with temozolomide (TMZ) chemotherapy starting at day 10 of the 4th TMZ cycle (treatment group 2) or at day 10 of the 1st TMZ cycle post concomitant radiochemotherapy (treatment group 3).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Targeting IDH1R132H in WHO Grade III-IV IDH1R132H-mutated Gliomas by a Peptide Vaccine - a Phase I Safety, Tolerability and Immunogenicity Multicenter Trial (NOA-16)|
|Actual Study Start Date :||June 2015|
|Actual Primary Completion Date :||September 19, 2017|
|Actual Study Completion Date :||September 19, 2017|
Experimental: IDH1 peptide vaccine
The IDH1 peptide vaccine is a 20mer peptide encompassing the IDH1R132H-mutated region emulsified in Montanide®. It is injected subcutaneously and administered in combination with topical imiquimod. The vaccine is administered 8 times every 2 or 4 weeks.
Drug: IDH1 peptide vaccine
- safety and tolerability of repeated fixed dose vaccinations of the IDH1 peptide vaccine administered with topical imiquimod (Aldara®) assessed by Regime Limiting Toxicity (RLT). [ Time Frame: 15 months ]Primary safety endpoint is the Regime Limiting Toxicity (RLT).
- immunogenicity of the IDH1 peptide vaccine [ Time Frame: 15 months ]The primary immunogenicity endpoint is the presence of an IDH1R132H-specific T-cell and/or antibody response at any time point during the trial measured by IFN-gamma ELISpot and ELISA, respectively (response Yes/No).
- immunogenicity by assessing the IDH1R132H-specific T-cell and antibody response [ Time Frame: 15 months ]
- progression-free survival (PFS) [ Time Frame: 15 months ]
- overall response rate (ORR) [ Time Frame: 15 months ]
- association between immunogenicity (IDH1R132H-specific T-cell and antibody response) and the clinical outcome parameters (ORR, PFS) [ Time Frame: 15 months ]assessed by Logistic regression and Proportional Hazard models
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02454634
|Charité Berlin, Neurosurgery|
|University Hospital Dresden, Neurosurgery|
|University Hospital Essen, Internal Medicine|
|University Hospital Frankfurt, Neurooncology|
|University Hospital Freiburg, Neurosurgery|
|University Hospital Heidelberg, Neurology Clinic|
|LMU, University Hospital Munich|
|University Hospital Tuebingen, Neurooncology|
|Principal Investigator:||Michael Platten, MD||University Hospital Heidelberg, Neurology Clinic; Neurooncology Program at the NCT|