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The Sidney Kimmel Comprehensive Cancer Center

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Clinical Trials

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.

More information.

Current Available Clinical Trials

Newly Diagnosed High Grade - Radiation Trials

Subventricular Zone (SVZ) and Temozolomide in Glioblastoma Multiforme

Objective: To see if the tumor is controlled for a longer period of time in patients treated with this modified radiation technique than it is in patients treated with standard radiation therapy plus temozolomide chemotherapy
Eligibility Criteria: Adults with newly-diagnosed glioblastoma (GBM)
Principle Investigator: Dr. Kristin Redmond
Contact: Danielle Wendler, R.N. (410-502-9243 or dschul15@jhmi.edu)

Newly Diagnosed High Grade - Therapeutic Trials

Study of the Effect NT-I7 on CD4 Counts in Patients With High Grade Gliomas

Objective: To find out the side effects and best dose of NT-I7 in treating patients with high-grade glioma.
Eligibility Criteria: Adults with high grade glioma (HGG)
Principle Investigator: Dr. Stuart Grossman
Contact: Michaella Iacoboni, RN (410-955-8837 or msheeh13@jhmi.edu)

Microtubule-Targeted Agent BAL101553 and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma

Objective: To find out the side effects and best dose of BAL101553 and radiaiton therapy in treating patients with gliobastoma.
Eligibility Criteria: Adults with newly-diagnosed glioblastoma (GBM)
Principle Investigator: Dr. Matthias Holdhoff
Contact: Michaella Iacoboni, RN (410-955-8837 or msheeh13@jhmi.edu)

Recurrent High-Grade - Radiation Trials

Low Dose Radiation Therapy for Glioblastoma Multiforme

Objective: To find out the side effects and how well low dose radiation and temozolomide work in treating patients with high grade gliomas that have come back
Eligibility Criteria: Adults with High Grade Glioma (HGG)
Principle Investigator: Dr. Kristin Redmond
Contact: Danielle Wendler, R.N. (410-502-9243 or dschul15@jhmi.edu)

Recurrent High-Grade - Therapeutic Trials

Trial of Anti-Tim-3 in Combination With Anti-PD-1 and SRS in Recurrent GBM

Objective: To find out the side effects of PDR001 and MBG453 given with stereotactic radiosurgery (SRS) in treading patients with glioblastoma that has come back.
Eligibility Criteria: Adults with glioblastoma (GBM) that has come back
Principle Investigator: Dr. Lawrence Kleinberg
Contact: Kelly Szajna, RN, BSN (410-502-4081 or kszajna@jhmi.edu)

AXL Inhibitor BGB324 in Treating Participants With Recurrent Glioblastoma Undergoing Surgery

Objective: To find out how well AXL inhibitor BGB324 works in treating participants who are undergoing surgery for glioblastoma that has come back
Eligibility Criteria: Adults under going surgery for glioblastoma (GBM) that has come back
Principle Investigator: Dr. Chetan Bettegowda
Contact: Michaella Iacoboni, RN (410-955-8837 or msheeh13@jhmi.edu)

Study of Binimetinib With Encorafenib in Adults With Recurrent BRAF V600-Mutated HGG

Objective: To find out how well encorafenib and binimetinib work in treating recurrent high-grade primary brain tumors.
Eligibility Criteria: Adults with high-grade tumors with BRAF-V600 E or K mutation
Principle Investigator: Dr. Karisa Schreck
Contact: Michaella Iacoboni, RN (410-955-8837 or msheeh13@jhmi.edu)

Terameprocol in Treating Patients With Recurrent High Grade Glioma

Objective: To find out the side effects and best dose of terameprocol in treating patients with high-grade glioma that has come back.
Eligibility Criteria: Adults with high grade glioma (HGG) that has come back
Principle Investigator: Dr. Stuart Grossman
Contact: Michaella Iacoboni, RN (410-955-8837 or msheeh13@jhmi.edu)

BGB-290 and Temozolomide in Treating Patients With Recurrent Gliomas With IDH1/2 Mutations

Objective: To find out the side effects and how well BGB-290 and temozolomide work in treating patients with gliomas (brain tumors) with IDH1/2 mutations that have come back
Eligibility Criteria: Adults with gliomas (brain tumors) that have come back
Principle Investigator: Dr. Stuart Grossman
Contact: Michaella Iacoboni, RN (410-955-8837 or msheeh13@jhmi.edu)