Treatment of relapsed or refractory high grade gliomas and diffuse intrinsic pontine gliomas in paediatric patients = 3 years and < 18 years of age. MedDRA version: 16.1 Level: PT Classification code 10002224 Term: Anaplastic astrocytoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 16.1 Level: LLT Classification code 10030288 Term: Oligodendroglioma malignant System Organ Class: 10029104 - Neoplasms benign, malignant and uns
Conditions
Interventions
Trade Name: Temodal
Product Name: Temodal
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: TEMOZOLOMIDE
CAS Number: 85622-93-1
Other descriptive name: 4-Methyl-5-oxo-2,3,4,6,8-pentazabicyclo[4.
Sponsors
Martin-Luther-Universität Halle-Wittenberg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of high-grade malignant glioma confirmed by central neuropathological review (last MRI diagnosis not older than 4 weeks) - including glioblastoma multiforme (WHO IV), anaplastic astrocytoma (WHO III), anaplastic oligodendroglioma (WHO III), anaplastic oligoastrocytoma (WHO III), anaplastic pilocytic astrocytoma (WHO III), anaplastic ganglioglioma (WHO III), anaplastic pleomorphic xanthoastrocytoma (analogous to WHO III), giant cell glioblastoma (WHO IV), and gliosarcoma (WHO IV) - or diagnosis of diffuse intrinsic pontine glioma confirmed by central neuroradiological review - refractory to standard treatment, or relapsed or progressive after first-line therapy. 2. Patient aged 3 years and older but under 18 years at time of relapse diagnosis 3. Written informed consent of the patient (mandatory from 15 years of age) or the parents (mandatory till 18 years of age). Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity or contraindication to any study drugs 2. Other (simultaneous) malignancies 3. Pregnancy and / or lactation 4. Patients who are sexually active refusing to use effective contraception (oral contraception, intrauterine devices, barrier method of contraception in conjunction with spermicidal jelly or surgical sterile) 5. Current or recent (within 30 days prior to start of trial treatment) treatment with another investigational drug or participation in another investigational trial 6. Severe concomitant diseases (e.g. immune deficiency syndrome) or HIV infection 7. Severe psychological disease or neurological damage without possibility to communicate 8. Clinical signs of intracranial pressure 9. Intracerebral hemorrhage or history of intracerebral hemorrhage 10. Following laboratory test results (not older than 2 weeks before patient´s inclusion): •Platelets < 100 000/µl (< 100 Gpt/l) •PT, INR and PTT above normal range •Absolute neutrophil count = 1 500/µl (< 1,5 Gpt/l) •Hemoglobin < 10g/dl (< 6,4 mmol/L) •Serum creatinine = 1,5 x upper limit of normal range or creatinine clearance rate = 60 ml/min/m2 (corrected for body surface area) •Total bilirubin = 1,5 x upper limit of normal range •SGOT (ASAT) and SGPT (ALAT) = 2,5 x upper limit of normal range •Alkaline phosphatase = 2,5 x upper limit of normal range 11. Hereditary Intrinsic Platelet Disorders 12.Ongoing irradiation or chemotherapy (within the last 4 weeks) 13. Estimated life expectancy of less than 2 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of a combined treatment with Cilengitide and metronomic oral Temozolomide in children and adolescents with relapsed or refractory high-grade malignant glioma and diffuse intrinsic pontine glioma, as indicated by 6 months overall survival (OS) after diagnosis of relapse or tumour progression, in comparison to a historical control group of paediatric HGG relapse patients from the HIT-GBM/HIT-HGG data base.;Secondary Objective: 1. To evaluate the safety and toxicity of the study treatment by common toxicity criteria (CTC; version 4.0). 2. To assess - the response rates at 6 months (continuous complete response = CCR, complete response = CR, partial response = PR, stable disease = SD, progressive disease = PD) and - progression-free survival (PFS) at 6 months, and - response rates, OS, and PFS at 12 months after relapse diagnosis or diagnosis of tumor progression. Response will be presented including histopathological variants. 3. To assess the pharmacokinetics of cilengitide administered as part of the study treatment. ;Primary end point(s): 6 month OS rate after diagnosis of relapse or tumour progression | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Safety and toxicity according to NCI CTC, version 4.0) 2. Response rates (CCR, CR, PR, SD, PD) and PFS at 6 months and response rates, PFS, and OS at 12 months after diagnosis of relapse or tumour progression 3. Pharmacokinetics of cilengitide in the study population | — |
Countries
Germany
Contacts
Public ContactHIT-HGG-Studienzentrale
Universitätsmedizin Göttingen
Outcome results
None listed