Diffuse Intrinsic Pontine Glioma Clinical Trial
Official title:
Cilengitide (EMD121974) in Combination With Irradiation in Children and Young Adults With Newly Diagnosed Diffuse Intrinsic Pontine Glioma: Phase I Study
The aim of the study is to determine the safety of Cilengitide in combination with radiation therapy.
The prognosis of children and young adults with a malignant glioma in the brain stem or a
recurrent malignant glioma (in whatever site) is very poor. Over the last few decades, many
therapeutic trials have been performed but have failed to significantly improve survival in
these patients. There is thus a need to test new drugs in these indications. There is a
strong biological rationale for the use of anti-angiogenic drugs in high-grade glioma.
Cilengitide (EMD121974; Merck KgaA, Darmstadt, Germany), a cyclic pentapeptide containing
the sequence RGD (cyclo-[Arg-Gly-Asp-Dphe-(NmeVal)]) is a selective antagonist of integrins
αvβ3 and αvβ5, which are strongly involved in tumour angiogenesis. Positive results with
Cilengitide in preclinical models of glioblastoma, its particularly attractive safety
profile and its encouraging efficacy in phase I and II studies in adults and children make
it a potentially effective molecule for the treatment of malignant glioma in children.
Furthermore, its combination with radiotherapy to be appears synergistic, without any
apparent increase in toxicity.
In this study, Cilengitide will be evaluated when concurrently administered with
radiotherapy as a first-line treatment and then as a maintenance monotherapy in children and
young adults with malignant brain stem glioma. The main objective will be to determine the
maximum tolerated dose (MTD) of Cilengitide when administered twice weekly as a 60-minute
intra-venous infusion.
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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