Autologous Dendritic Cells, Metronomic Cyclophosphamide and Checkpoint Blockade in Children With … (NCT03879512) | Clinical Trial Compass
CompletedPhase 1/2
Autologous Dendritic Cells, Metronomic Cyclophosphamide and Checkpoint Blockade in Children With Relapsed HGG
Germany24 participantsStarted 2018-02-07
Plain-language summary
This phase I/II trials evaluates the feasibility, safety and efficacy of an individualized cancer vaccine, based on autologous, tumor-lysate loaded dendritic cells in children and adolescents with relapsed high-grade gliomas. In addition, regulatory T cells are depleted by a short cycle of metronomic cyclophosphamide upfront of the vaccine in order to facilitate induction of immune responses.
Therapeutic DC vaccines are followed by four cycles of Nivo/Ipi double checkpoint blockade and a Nivolumab monotherapy maintenance in order to optimize the induced T-cell response.
Who can participate
Age range3 Years – 21 Years
SexALL
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Inclusion criteria
✓. Diagnosis of relapsed high-grade malignant glioma confirmed by central neuropathological and neuroradiological review (last magnetic resonance imaging diagnosis not older than 4 weeks) - including glioblastoma multiforme (WHO IV), anaplastic astrocytoma World Health Organization (WHO III), anaplastic oligodendroglioma (WHO III), anaplastic oligoastrocytoma (WHO III), anaplastic pilocytic astrocytoma (WHO III), anaplastic ganglioglioma (WHO III), anaplastic pleomorphic xanthoastrocytoma (analogous to WHO III), giant cell glioblastoma (WHO IV), and gliosarcoma (WHO IV) relapsed after first-line therapy.
✓. Patients aged 3 years and older but under 21 years at time of relapse diagnosis
✓. Written informed consent of the patient (mandatory from 14 years of age) or the parents (mandatory till 18 years of age).
✓. Prospect of resection of relapse tumour by neurosurgery (total, subtotal or partial)
Exclusion criteria
✕. Known hypersensitivity or contraindication to cyclophosphamide
✕. Known hypersensitivity or contraindications to Nivolumab or Ipilimumab.
✕. Other malignancies, either simultaneous or within the last 2 years
✕. Active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
✕. Pregnancy and / or lactation
✕. Patients who are sexually active refusing to use effective contraception (oral contraception, intrauterine devices, barrier method of contraception in conjunction with spermicidal jelly or surgical sterile)
✕. Current or recent (within 4 weeks prior to start of trial treatment) treatment with another investigational drug or participation in another investigational trial
✕. Severe concomitant diseases (e.g. immune deficiency syndrome)