Clinical Trials

Clinical trials are research studies to test new ways to treat cancer. You may be eligible to join a trial, but ask your doctor about the benefits and risks. There are four phases of clinical trials.

Phases of Clinical Trials

Clinical Phase Description Number of Patients
Examines the safety of a product in a very small group of healthy volunteers or patients afflicted with a specific disease, this phase also helps determine appropriate dose ranges 20-80 patients
Evaluates the safety and efficacy of the product at a pre-determined dose in comparison to the standard care treatment (i.e. commercially available therapies commonly used to treat the same disorder or disease) 100-300 patients
Tests the product in comparison to the standard care treatment with a large and diverse population to determine efficacy and usage guidelines 1000-3000 patients
Determines the long-term effects of a drug after the FDA has approved it for public use All patients prescribed the drug by a treating physician

Before Joining a Trial

There are a few things that you should consider before joining a clinical trial. First is that once you start chemotherapy and radiation you may become ineligible for a significant number of trials. So if possible evaluate the clinical trial options with your doctor before you start chemo and radiation.

All clinical trials treatments can have different side effects depending on what treatment is being tested, so it is vital to discuss this with your doctors. If researchers learn that a treatment harms you, you will be taken off the study right away. You may then receive other treatments.

Remember: you have the right to leave a study at any time.

Possible side effects should also be enumerated in the release that you sign to in your agreement to participate in the trial. By nature of the trial, you also may be put in the placebo group that does not receive the experimental treatment.

Not all trials are about finding new drugs. Non-therapeutic clinical trials involve monitoring some aspect of a patient’s health throughout the course of his or her care without adding a new investigational agent to the patient’s current treatment. This could be something like a diet, for example. They can be a lower-risk way to help add to science’s body of knowledge on cancer.

Finding Clinical Trials

You can research clinical trials yourself online or with the help of a nurse advocate.  The National Cancer Institute web site has a section on clinical trials and includes detailed information about specific ongoing studies of brain tumors. NCI's Information Specialists at 1-800-4-CANCER (1-800-422-6237) and at LiveHelp can answer questions and provide information about clinical trials.

The Brain Tumor Network (BTN) will conduct a personalized clinical trial sort for you, taking into consideration your brain tumor diagnosis and treatment history, your geographic location, and ability/desire to travel.  The BTN staff will equip you with information so you can discuss options with your physician. Call 1.844.286.6110

ABC2-Supported Trials Currently Recruiting Participants

Phase 1 Study Using Toca 511
This is a multicenter, open-label, ascending-dose trial of the safety and tolerability of increasing doses of Toca 511, a Retroviral Replicating Vector (RRV), administered to subjects with recurrent high grade glioma (rHGG) who have undergone surgery followed by adjuvant radiation therapy and chemotherapy.
Who Is Eligible: 
Patients With Recurrent High Grade Glioma
Phase 1 Study Using Personalized NeoAntigen Vaccine With Radiotherapy
This trial is studying a new type of vaccine as a possible treatment for patients with MGMT-unmethylated glioblastoma. The trial is being conducted at Dana-Farber Cancer Institute in Boston, MA.
Who Is Eligible: 
Patients With MGMT Unmethylated, Newly Diagnosed Glioblastoma
Phase III Study Using DCVax®-L
The primary purpose of the study is to determine the efficacy of an investigational therapy called DCVax(R)-L in patients with newly diagnosed GBM for whom surgery is indicated.
Who Is Eligible: 
Newly Diagnosed Glioblastoma Patients
Phase 1 Study of Orally Administered AG-120
The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-120 in advanced solid tumors, including glioma, that harbor an IDH1 mutation.
Who Is Eligible: 
Patients With Advanced Solid Tumors, Including Glioma, With an IDH1 Mutation