Dendritic Cell Cancer Vaccine for High-grade Glioma

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

A randomised, open-label, 2-arm, multi-centre, phase II clinical study with one group receiving standard therapy with Temozolomide, radiotherapy, and Trivax; and a control group receiving standard therapy with Temozolomide and radiotherapy only; after tumour resection of at least 70% in both groups. The hypothesis is based on the assumption that time to progression will be doubled in the treatment group.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Activartis Biotech
• Treatments: Dacarbazine; Interleukin-12; Temozolomide

Criteria

Inclusion Criteria:

• Female or male, paediatric or adult patients of 3 to 70 years of age at time of diagnosis that qualify for standard treatment including surgery, Temozolomide and radiotherapy.

• GBM (WHO IV), confirmed by histology.

• Total, subtotal, or partial resection of more then 70% of tumour mass defined by MRI.

• Supratentorial tumour localisation.

• ECOG performance status 0, 1, or 2 (for study patients older 18 years).

• Life expectancy of at least 12 weeks by assessment of the attending physician.

• Written informed consent of patient and/or legal guardian in case of children or adolescents.

Exclusion Criteria:

• Less than 100 µg of tumour protein obtained from the resected tissue.

• Anti-neoplastic chemotherapy or radiotherapy during 4 weeks before entering the study, e.g. in another therapeutic phase I, II, or III study.

• Positive pregnancy test or breast-feeding.

• Patients unwilling to perform a save method of birth control.

• Known hypersensitivity to temozolomide.

• HIV positivity.