Cilengitide Imaging Trial in Glioblastoma

Merck KGaA (EMD Serono)

Status and phase

Terminated

Phase 1

Conditions

Supratentorial Newly Diagnosed Inoperable Gliobastoma

Treatments

Drug: Drug (including placebo)

Other: Standard therapy

Study type

Interventional

Funder types

Industry

Identifiers

NCT01558687

EMR062041-017

2011-003794-29 (EudraCT Number)

Details and patient eligibility

About

The main purpose of this clinical trial is to find out if cilengitide has an effect on brain tumor cells but also particularly on the blood vessels supplying the tumor with nutrient and oxygen in patients newly diagnosed with non-resectable (inoperable) glioblastoma.

In addition, this clinical trial will investigate if the addition of cilengitide in combination with standard treatment prolongs life in patients with non-resectable glioblastoma. Similarly, the duration of response of the cancer to this treatment and the side effects of the therapy will be analyzed. Furthermore, additional data on how the body deals with this substance will be collected (this is called pharmacokinetics or pharmacokinetic (PK) analysis). In this clinical trial the investigators would also like to learn more about the disease and the response to the experimental medication by measuring certain "markers".

This imaging trial will investigate the biological effects of cilengitide monotherapy on the tumor microvascular function and tumor viability in a homogenous non-pretreated subject population with newly diagnosed Gliobastoma (GBM). The purpose of this clinical trial is to study the effect that cilengitide may have on certain markers of cancer in your tumor and/or blood and to learn if there are any disease-related markers that could help in predicting how subjects respond to the administration of cilengitide.

The investigators anticipate that approximately 30 subjects will participate in this clinical trial. The clinical trial will be conducted in approximately 4 medical centers in the following countries: Germany, Poland, and Switzerland. The investigators anticipate the clinical trial will last until the end of 2013. Your participation in the trial may last up to 86 weeks.

Enrollment

1 patient

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female subject aged ≥ 18 to ≤ 70 years at the time of informed consent signature
Tumor tissue specimens taken from multimodal imaging-guided stereotactic biopsy must be available for histopathological confirmation of GBM and potential subsequent analysis of tissue molecular markers
Newly diagnosed histologically proven supratentorial GBM (World Health Organization [WHO] Grade IV)
Subject with non-resectable GBM
Available dynamic MRI and FET-PET scan prior to randomization
Available Gd-MRI performed prior randomization
ECOG Performance status of 0-2
Stable or decreasing dose of steroids for >= 5 days prior to randomization
Given written informed consent

Exclusion criteria

Prior chemotherapy within the last 5 years
Prior RTX of the head (except for low-dose radiotherapy for Tinea capitis)
Gross total resection/partial resection (GBM surgery), placement of Gliadel® wafer
Receiving concurrent investigational agents or receipt of an investigational agent within the past 30 days prior to the first day of intensified imaging (W1D1)
Prior systemic antiangiogenic therapy
Inability to undergo dynamic MR or FET-PET imaging
History of allergic reactions attributed to Gadolinium-based contrast agents for MRI, compounds of similar chemical or biological composition
Planned major surgery for other diseases
History of recent peptic ulcer disease (endoscopically proven gastric ulcer, duodenal ulcer, or esophageal ulcer) within 6 months prior to enrollment
History of other malignant disease or acute malignant disease. Subjects with curatively treated cervical carcinoma in situ or basal cell carcinoma of the skin, or subjects who have been free of other malignancies for ≥ 5 years are eligible for this study
Current or history of bleeding disorders and/or history of thromboembolic events
Clinically manifest myocardial insufficiency (NYHA III, IV) or history of myocardial infarction during the past 6 months prior to enrollment, uncontrolled arterial hypertension