Glioblastoma Multiforme - braintumor
Conditions
Interventions
The intervention will consist of intratumoral slow delivery by CED of the study
drug. For this the patient will be admitted during 6 days . In a surgical
procedure under general anesthesia 3 cathete
Braintumor
Glioblastoma
Sponsors
Stemgen
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Patients at least 18 years of age with malignant glioma (WHO grade IV) who have undergone conventional treatment, including surgery (gross total resection or unintentional partial resection with residual tumour) or biopsy (with residual tumour), and/or radiation therapy, and/or chemotherapy, and have progressive and/or multiple recurrent GBM.
Exclusion criteria
Exclusion criteria: Patients who had chemotherapy, radiotherapy or other anti-neoplastic therapy (within 4 weeks or 5x half-life whichever is shorter) prior to study treatment or those who have not recovered from toxicity to the last therapy. Patients in bad neurological condition, with a KPS lower than 70.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study will be to evaluate the feasibility and safety of intra-tumour and peri-tumour therapy with GMP hBMP4 in increasing doses in patients with progressive and/or multiple recurrent GBM, identify DLT, and to determine whether there is a maximum tolerated dose (MTD). | — |
Secondary
| Measure | Time frame |
|---|---|
| secondary endpoints are: tumor response measured on MRI scans, pharmacokinetics of hrBMP4 in blood and quality of life. | — |
Countries
Germany, Israel, Italy, Netherlands
Outcome results
None listed