Personalized Vaccination in Fusion+ Sarcoma Patients (PerVision)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age2-40
SponsorUniversity Hospital Tuebingen
About this trial
The PerVision trial utilizes an approach of a patient-individual cancer vaccine with sarcoma-specific peptides in metastasized fusion-driven sarcoma patients determined by next generation whole exome sequencing of tumor and normal tissue as well as RNA sequencing of the tumor.
This approach is applicable to all patients independent of the expression of distinct tumor associated antigens, and independent of their human leukocyte antigen-typing (HLA-typing). The results of this study can directly be translated to other tumor entities.
It is an interventional, multicenter, open-label, phase I/II feasibility and early proof of concept study evaluating a personalized peptide vaccine.
Primary objective is to evaluate safety and success of treatment, the latter be defined as vaccination-induced T-cell response without unacceptable toxicity.
Eligibility criteria
Qualifiers
Confirmed metastatic fusion-driven rhabdomyosarcoma, Ewing- and synovial sarcoma in first or second complete remission (CR) or partial response (PR) after local therapy and intensive standard chemotherapy protocols.
Whole exome sequencing and RNA sequencing data of the gene fusion (fusion-breakpoint RNA sequence) must be available by registration to the INFORM (Individualized therapy for relapsed malignancies in childhood), MASTER (Register study Molecularly Aided Stratification for Tumor Eradication) or HEROES-AYA networks (Heterogeneity, evolution and resistance of fusion-driven sarcomas in AYA) or similar evaluation.
Design and production of the patient-individual vaccine cocktail was successful
Patients have reached a complete or stable partial remission (CR or PR) the end of adjuvant and/or maintenance cytotoxic treatment. Cytotoxic treatment as per standard or trial recommendations has been completed. Definition of PRplus: Partial remission(plus) implicates that all remaining tumor residua including all metastases have received local therapy by this time point: Either surgical removal or local irradiation. The assessment of which therapy modality and, in the case of irradiation, which radiation dose is selected, lies with the treating physician. Whether PRplus is achieved will be decided finally by the investigator after review of the patient records.
Disqualifiers
Ejection fraction < 25%
Creatinine-clearance < 40ml/min
Bilirubin > 4mg/dl
Alanine aminotransferase (ALT) > 400 units (U)/l and/or aspartate aminotransferase (AST) > 400 U/l
Trial design
Treatments tested in this trial
- Peptide vaccine IPX
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
University Hospital Tuebingen
Lead sponsor
Deutsches Konsortium fürTranslationale Krebsforschung (DKTK)
Collaborator
Cooperative Ewing Sarkom Studiengruppe
Collaborator
Cooperative Weichteilsarkom Study Group
Collaborator
Source ClinicalTrials.gov