Clinical trials are scientific studies in which new treatments (drugs, diagnostic procedures and other therapies) are tested in patients to determine if they are safe and effective. Nearly all of the cancer drugs in use today were tested and made available to patients through clinical trials.
Who Can Participate in a Clinical Trial?
To qualify for a particular clinical trials, participants must meet a carefully defined set of criteria. These criteria usually relate to age and gender, cancer type and stage, and the types of treatments they have already received. Before agreeing to participate, patients will learn about the possible risks and benefits of the therapy being studied. Participants may withdraw from the trial at any time.
How Are Patients Protected?
Before any clinical trial begins, it must be approved by the institution's Institutional Review Board (IRB). This review board includes researchers and physicians. The IRB considers whether proposed studies are safe and well planned and whether they will advance patient care. It also reviews studies to ensure patients are adequately informed about the risks of participating in clinical research. In all studies, the health of the patient is closely monitored during the course of the trial.
What Are the Phases of Clinical Trials?
Cancer Clinical Trials are divided into three distinct stages. Only when the third stage has been successfully completed, and the Food and Drug Administration has given its approval, can a new treatment become part of standard therapy.
- Phase I Trials: These first studies evaluate how a new drug should be given (by mouth, injected into the blood, or injected into the muscle), how often, and what dose is safe. A phase I trial usually enrolls only a small number of patients, sometimes as few as a dozen.
- Phase II Trials: A phase II trial provide information about how well the new drug works and continues to evaluate the safety of the drug. Phase II studies usually focus on a particular type of cancer.
- Phase III Trials: These studies test a new drug, a new combination of drugs, or a new surgical procedure in comparison to the current standard. A participant will usually be assigned to the standard group or the new group at random (called randomization). Phase III trials often enroll large numbers of people and may be conducted at many doctors' offices, clinics and cancer centers nationwide.
Newly Diagnosed High-Grade - Therapeutic Trials
N1201 - Phase I (MK-1775) - Phase I Study of MK-1775 with Radiation and Temozolomide in patients with newly diagnosed glioblastoma and evaluation of intratumoral drug distribution in patients with recurrent glioblastoma.
This research is being done to test the best dose of MK-1775 to give to patients with glioblastoma's when taking temozolomide every day during the 6 weeks of radiation therapy.
Contacts: Stuart Grossman, MD, Silvia Petrik, RN - 410-502-5343
J1195 - Phase I (Mebendazole) - Phase I Study of mebendazole in newly diagnosed high-grade glioma patients receiving treatment.
To determine the maximum tolerated dose of mebendazole in combination with temozolomide given after surgery and standard radiation / TMZ treatment in patients with newly diagnosed GBM.
Contacts: Gary Gallia, MD, Sue Zhen, RN - 410-502-4081
J1345 - Quantitative MRSI to Predict Early Response to Standard RT/Temozolomide+ Corinostat Vorinotat Therapy in Newly Diagnosed Glioblastoma
The first part of the study will involve we will be doing only MRSI Scans, then Vorinostat will be add it.
Contacts: Matthias Holdhoff, MD, Silvia Petrik, RN - 410-502-5343.
J1444 - The Feasibility and Biologic Effect of a Modified Atkins-based Intermittent Fasting Diet in Patients with Glioblasoma (GBM)
The purpose is to determine whether a new diet that is low in sugar and calories called the GLAD diet (Glioma Atkins-based Diet) is safe and feasible in people with brain tumors.
Contacts: Jaishri Blakeley, MD, Lindsay Blair, NP - 410-955-8009.
Newly Diagnosed High-Grade - Radiation Trials
J1426 - Phase II - A Randomized Phase II Study of Subventricular Zone (SVZ) Irradiation Plus Temozolomide in Newly Diagnosed Glioblastoma Multiforme
This research is being done to see if an investigational (drugs have not been approved by the US Food and Drug Administration for marketing. However, the FDA is allowing the drug to be used in a limited number of people in this study) method of giving radiation to adults with glioblastoma multiforme (GBM) can improve the local control and increase the time it may take for your brain cancer from coming back.
Contacts: Kristin Redmond, MD, Kelly Szajna, RN - 410-614-3950.
Newly Diagnosed High-Grade - Blood Trials
J14108- The Association Between Lymphopenia in Patients with Cancer Receiving External Beam Radiation and the Ability of Their Lymphocytes to Repair Radiation-Related DNA Double-Strand Breaks.
Single blood draw.
Contacts: Anna Piotrowski, MD, Silvia Petrik, RN - 410-502-5343
Recurrent High-Grade - Therapeutic Trials
N1302 - Phase I - ON HOLD - Drug Distribution and Pharmacodynamic Study of Pulsatile Lapatinib in Surgically Accessible EGFR-Amplified Recurrent High-Grade Glioma
The purpose of this study is to determine how much of the study drug, called Iapatinib, reaches the brain tumor. This study is only for people who require surgery for their brain tumor. Lapatinib is not FDA-approved to treat brain cancer but it has been FDA-approved to use in other types of tumors in humans.
Contacts: Stuart Grossman, MD, Silvia Petrik, RN - 410-502-5343
J14155 - Brain Interstitium Temozolomide Concentration Pre and Post Regadenoson Administration
To measure brain interstitium temozolomide concentration pre and post Regadenoson using intracerebral microdialysis in recurrent high grade glioma patients.
Contacts: Sadhana Jackson, MD, Stuart Grossman, MD, Silvia Petrik, RN - 410-502-5343
J1404 - Phase II B - A Randomized Phase IIB Open Label Study of Nivolumab or Nivolumab in Combination with Ipilimumab versus Bevacizumab in Adult Subjects with Recurrent Glioblastoma (GBM)
The study is divided into two cohorts (groups). The purpose of Cohort 1 is to test the safety and tolerability of nivolumab, either alone or in combination with a drug called ipilimumab (alson known as Yervoy) in patients diagnosed with glioblastoma.
Contacts: Michael Lim, MD, Sue Zhen, RN - 410-502-4081
N1301 - Pilot Study - Pilot Study of MLN0128 in Preoperative Recurrent GBM pts
Two part study: Part 1: Pre-surgery treatment - evaluate penetration of drug across BBB Part 2: Pre-surgery treatment vs no pre-surgery treatment - ability of drug to inhibit TORC1/2.
Contacts: Stuart Grossman, MD, Silvia Petrik, RN - 410-502-5342.
Recurrent High-Grade - Radiation Trials
J11120 - Phase II - A Phase II Trial of Low Dose Fractionated Radiation Therapy as a Chemo-potentiator of Salvage Temozolomide for Recurrent Glioblastoma Multiforme
This study is to see if an investigational (drugs that have not been approved by the US Food and Drug Administration for marketing. However, the FDA is allowing the drug to be used in a limited number people in this study) manner of delivering very low doses of radiation therapy makes the chemotherapy pill temozolomide work better.