Cilengitide and Metronomic Temozolomide for Relapsed or Refractory High Grade Gliomas or Diffuse Intrinsic Pontine Gliomas in Children and Adolescents - A Phase II Study - HIT-HGG-CilMetro

Phase 1

• Conditions: 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: 16.1Level: PTClassification code 10002224Term: Anaplastic astrocytomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 16.1Level: LLTClassification code 10030288Term: Oligodendroglioma malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 16.1Level: PTClassification code 10065443Term: Malignant gliomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 16.1Level: PTClassification code 10006143Term: Brain stem gliomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 16.1Level: PTClassification code 10060971Term: Astrocytoma malignantSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 16.1Level: PTClassification code 10017701Term: GangliogliomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 16.1Level: PTClassification code 10018337Term: Glioblastoma multiformeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 16.1Level: LLTClassification code 10003572Term: Astrocytoma malignant NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 16.1Level: PTClassification code 10018336Term: GlioblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2009-011898-33-DE
• Lead Sponsor: Martin-Luther-Universität Halle-Wittenberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-06-10
• Study Completion: 2014-03-07
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified