Overview

Safety and Imaging Study of GC1008 in Glioma

Status:
Completed
Trial end date:
2012-11-01
Target enrollment:
Participant gender:
Summary
Brain tumors account for only 2% of all cancers but result in a disproportionate share of cancer morbidity and mortality. The five-year survival rates for the most common histologic subtypes, anaplastic astrocytoma and glioblastoma (glioblastoma multiforme, GBM), are 30% and 10%, respectively. Drugs affecting transforming growth factor-β (TGF-β) might be of great interest for malignant glioma treatment. TGF-β is an oncogenic factor in advanced tumors where it induces proliferation, angiogenesis, invasion, and metastasis as well as suppresses the antitumoral immune response. In addition TGF-β and its TGF-β receptors, TβRI and TβRII, are overexpressed in GBMs. TGF-β signaling is involved in multiple steps of GBM development. GC1008 is an antibody that is capable of neutralizing TGF-β and may therefore offer a new treatment option for patients with malignant glioma. For therapeutic success, it may be essential for GC1008 to reach the target site, in this case located in the brain. We will be able to prove this with 89Zr-GC1008 PET imaging. This imaging method also allows quantification of the amount of GC1008 reaching the tumor. This study consists of 2 parts. In part 1, patients with a suspicion of a malignant glioma undergo an 89Zr-GC1008 PET scan before standard (surgical)treatment. In part 2, patients with relapsed malignant glioma will undergo an 89Zr-GC1008 PET scan and will be treated with GC1008 in a phase II study as there is no standard treatment for these patients. We hypothesize that GC1008 uptake in brain tumors can be visualized and quantified using the 89Zr-GC1008 PET scan and GC1008 might offer a new treatment option for patients with relapsed malignant gliomas.
Phase:
Phase 2
Details
Lead Sponsor:
University Medical Center Groningen
Collaborator:
Genzyme, a Sanofi Company
Treatments:
Antibodies, Monoclonal