BTTC Clinical Trials

Team Studying Three Treatment Regimens

 
An open trial follows a predefined protocol so that the research team and the patient have a complete understanding of the details of the program. Specifically regarding the BTTC, current studies are investigating the effectiveness and safety of three treatment regimens involving malignant gliomas, the most common and most aggressive type of adult brain tumors. The three-year survival rate of glioblastoma multiforme patients is less than 2 percent.
 

Open BTTC Clinical Trials

Pazopanib/Topotecan Study

The study’s primary objective is to learn if pazopanib when given in combination with topotecan can help to control glioblastoma. The safety of this drug combination will also be studied. A phase II trial of pazopanib and topatecan in adult patients with recurrent glioblastoma.

Vimpat vs. Placebo Study

This study’s primary objective is to determine if prophylactic administration of lacosamide reduces the risk of seizures in patients with a high-grade glioma. Newly diagnosed, post-operative patients are tested during the first year after tumor diagnosis.

Everolimus/Sorafenib Study

This study will evaluate the occurrence of symptoms and their relations to disease progression, as well as the tolerance to treatment regimen. A phase I-II trial everolimus and sorafenib in patients with recurrent high-grade gliomas.

Bevacizumab/Vorinostat Study

This study will look at evaluating the occurrence of symptoms and their relations to disease progression, as well as the tolerance to the treatment regimen. Phase I/II adaptive randomized trial of bevacizumab versus bevacizumab plus vorinostat in adults with recurrent glioblastoma.

 

Completed BTTC Clinical Trials

Avastin/Tarceva Study

The study evaluated the effects and determined overall survival rates of newly diagnosed malignant glioma patients when administering a combination of bevacizumab (Avastin) and erlotinib (Tarceva) following the completion of radiation therapy with temozolomide (Temodar).

Temodar Combination Study

The study determined if temozolomide (Temodar) administered alone or in combination with thalidomide (Thalomid™), isotretinion (Accutane) and/or celecoxib (Celebrex) was effective in the continued treatment of newly diagnosed glioblastoma multiforme patients who already had incurred radiation therapy. Also, the toxicity of this adjuvant treatment was studied.

 

Participation and Screening Process

The clinical trial, which includes doctors, nurses and other health care professionals, involves an initial review of the patient’s condition or overall health, monitoring the patient during the trial, and maintaining post-trial contact with the patient.

Before performing any of the study’s related procedures, the research team provides the patient with the complete information necessary to make a proper decision about participating in the study. The process is known as the informed consent. It is mandatory that a patient sign an informed consent form (ICF) before the research team performs any procedures.

After the ICF is signed, the patient begins the screening process, which determines participation eligibility. Each study includes a list of inclusion and exclusion criteria and a unique list tailored to the respective treatment being studied.