Cilengitide Imaging Trial in Glioblastoma
|ClinicalTrials.gov Identifier: NCT01558687|
Recruitment Status : Terminated (Discontinuation of development program)
First Posted : March 20, 2012
Last Update Posted : February 4, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Supratentorial Newly Diagnosed Inoperable Gliobastoma||Drug: Drug (including placebo) Other: Standard therapy||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||A Multi-center, Open-label, Randomized, Controlled Phase I Trial to Investigate the Effects of Cilengitide (EMD 121974) Using Dynamic MR and FET-PET Imaging as a Pharmacodynamic Measure of Response in Subjects With Newly Diagnosed Glioblastoma|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
Experimental: Group A = Cilengitide Group
Cilengitide + SoC (Temolozomide + Radiotherapy)
Drug: Drug (including placebo)
Subjects will receive cilengitide monotherapy for 2 weeks (Weeks 1 and 2); thereafter, cilengitide will be given in combination with the standard treatment regimen during Weeks 3 to 36. The standard combination treatment of radiotherapy (RTX) plus Temolozomide (TMZ) will be administered for a maximum of 6 weeks (Weeks 3 to 8), followed by TMZ maintenance treatment starting 4 weeks after RTX (i.e., Week 13) for up to 6 cycles, 4 weeks per cycle.
Cilengitide monotherapy treatment will be given to subjects in Group A for another 10 months as maintenance treatment (Weeks 37 to 78). Subjects in Group A may continue to receive cilengitide maintenance treatment beyond 10 months (beyond Week 78) until occurrence of progressive disease (PD) or unacceptable toxicity, or withdrawal for any other reason. A 28-day safety follow-up will be performed after the last dose of cilengitide.
Active Comparator: Group B = Control Group
SoC (Temolozomide + Radiotherapy)
Other: Standard therapy
In the first two weeks, treatment of subjects in Group B will be in line with the SoC. Thereafter the standard combination treatment of radiotherapy (RTX) plus Temolozomide (TMZ) will be administered for a maximum of 6 weeks (Weeks 3 to 8), followed by TMZ maintenance treatment starting 4 weeks after RTX (i.e., Week 13) for up to 6 cycles, 4 weeks per cycle.
- Rate constant for passive contrast agent plasma/interstitium transfer (ktrans) [ Time Frame: 2 weeks ]Any change in tumor kinetic model parameter (maximum increase in ktrans) to assess the tumor microvasculature structure and function
- Fractional blood plasma volume (vp) [ Time Frame: 2 weeks ]Any change in tumor kinetic model parameter (maximum change in vp) to assess the tumor microvasculature structure and function
- Maximum tumor to brain ratio (TBRmax) [ Time Frame: 2 weeks ]Assessment of tumor amino acid (FET) uptake (tumor viability)
- Total tumor volume and enhancing tumor volume [ Time Frame: 2 weeks ]Change in total tumor volume and enhancing tumor volume as a measure of the overall level of tumor perfusion during the first 2 weeks of treatment with Cilengitide monotherapy
- Interstitial space volume fraction (putative contrast agent distribution volume) (=ve) [ Time Frame: 2 weeks ]Change in the tumor extravascular extracellular space volume during the first 2 weeks of treatment with Cilengitide monotherapy
- Apparent Diffusion coefficient (ADC) [ Time Frame: 2 weeks ]Change in perfusion parameter ADC during the first 2 weeks of treatment with Cilengitide monotherapy
- Fractional anisotropy (FA) [ Time Frame: 2 weeks ]Change in FA during the first 2 weeks of treatment with Cilengitide monotherapy
- Kinetic behavior of [18F]FET uptake [ Time Frame: 2 weeks ]Change in tumor amino acid (FET) uptake kinetics during the first 2 weeks of treatment with Cilengitide monotherapy
- Mean spin-lattice relaxation time of unbound protons in water [ Time Frame: 2 weeks ]Change in Absolute T1(mean spin-lattice relaxation time of unbound protons in water) during the first 2 weeks of treatment with Cilengitide monotherapy
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01558687
|Merck KGaA Communication Center located in|
|Study Director:||Ute Klinkhardt, MD||Merck KGaA|