Brain Tumor Clinical Trials

The following clinical trials for the treatment of various brain cancer conditions are available for your participation. Click the study number to view details of eligibility criteria.

Clinical trials are grouped by tumor type, and within each tumor type by course of treatment:

Glioblastoma Multiforme (newly diagnosed, after radiation therapy, recurrent)
Anaplastic Gliomas & Mixed Tumors (newly diagnosed, recurrent)
High-Grade Gliomas
Ependymoma
Meningioma
Leptomeningeal Metastases

Last updated 03/20/13

Glioblastoma Multiforme

Newly Diagnosed

2011-1124: A Phase I, Two-Stage, Multi-Center, Open-Label Dose-Escalation Study of BKM120 in Combination with Adjuvant Temozolomide and with Concomitant Radiation Therapy and Temozolomide in Patients with Newly Diagnosed Glioblastoma
Principal Investigator: John F. de Groot, M.D.

To estimate the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of BKM120 in three sequential treatment phases (C, A1 and A2), when combined with the approved first line treatment of temozolomide-radiotherapy in patients with newly diagnosed glioblastoma(GBM).

Newly Diagnosed - After Radiation Therapy

2011-0374: A Phase I lead-in to a 2x2x2 Factorial Trial of Dose Dense Temozolomide, Memantine, Mefloquine, and Metformin as Post-Radiation Adjuvant Therapy of Glioblastoma Multiforme
Principal Investigator: Marta Penas-Prado, M.D.

The goal of the study is to find the highest tolerable dose of temozolomide in combination with memantine, mefloquine and/or metformin that can be given to patients with glioblastoma who have already been given radiation and chemotherapy in combination. Temozolomide is designed to kill cancer cells by damaging DNA (the genetic material of cells). The damaged DNA may cause tumor cell death. Memantine id designed to block the activity of a protein found on the surface of cells that may control tumor growth and survival. This may stop further spread of tumor cells. Mefloquine is designed to block a protein that helps to clean the waste in the cells and to destabilize the cell membrane. Blocking this protein may cause tumor cell death. Metformin is designed to block a protein in tumor cells that is important in tumor growth and blood vessel development. This may cause cell death or reduce the spread of the disease. The safety of these drug combinations will also be studied.

Recurrent

2012-0256: Initial Phase I Study of WT2725 Dosing Emulsion in Patients with Advanced Malignancies
Principal Investigator: Siqing Fu, M.D, Ph.D

The goal of this clinical research study is to find the highest tolerable dose of WT2725 that can be given to patients with advanced cancer. The safety of WT2725 will also be studied.

WT2725 is a vaccine designed to help your immune system to fight against the cancer cells by targeting a protein found in cancer cells called WT1. It is hoped that this may slow down the growth of or kill cancer cells. This is the first study using WT2725 in humans.

2011-0746: A Phase I/Ib, Open-label Study in Patients with Recurrent Glioblastoma to Assess the Safety and Tolerability of Macitentan in Combination with Dose-dense Temozolomide
Principal Investigator: Charles A. Conrad, M.D.

The goal of this clinical research study is to find the highest tolerable dose of macitentan combined with temozolomide that can be given to patients with glioblastoma or gliosarcoma. Researchers also want to learn quickly how the study drug spreads through the body once it has been given. The safety of these drugs given together will also be studied.

Macitentan is designed to block several proteins on the surface of the cells that are important to the growth and division of cancer cells and the growth of blood vessels, which may cause the cancer cells to di3e.

Temozolomide is designed to damage the DNA cancer cells. The damaged DNA may cause tumor cell death.

2011-0307: A Phase II Study of BKM120 for Patients with Recurrent Glioblastoma and Activated PI3K Pathway
Principal Investigator: W. K. Alfred Yung, M.D.

The goal of this clinical research study is to learn if BKM120 can help to control glioblastoma and/or gliosarcoma. BKM120 is designed to block a protein that is important to the growth and division of cancer cells, which may cause cells to die. Researchers also want to learn more about how much BKM120 is in different areas of the body at different points of time. The safety of the drug will also be studied.

BTTC11-02: Phase I/II Adaptive Randomized Trial of Bevacizumab versus Bevacizumab plus Vorinostat in Adults with Recurrent Glioblastoma
Principal Investigator: Marta Penas-Prado, M.D.

The goal of this Phase II part of this clinical research study is to learn if bevacizumab when given with or without vorinostat can help to control malignant gliomas. The safety of these drug combinations will also be studied.

BTTC09-01: A Phase I-II trial everolimus and sorafenib in Patients with Recurrent High-Grade Gliomas
Principal Investigator: Marta Penas-Prado, M.D.

The goal of Phase 1 of this clinical research study is to find the highest tolerable dose and best schedule of the combination of everolimus and sorafenib that can be given to patients with malignant glioma.

The goal of Phase 2 of this study to learn if the combination of everolimus and sorafenib can help to control malignant glioma. The safety of this combination will also be studied in both phases.

2009-0597: Randomized Phase II Trial of Standard Dose Bevacizumab Versus Low Dose Bevacizumab plus Lomustine (CCNU) In Adults with Recurrent Glioblastoma Multiforme
Principal Investigator: John F. de Groot, M.D.

Bevacizumab targets the ability of tumor cells to promote the increased blood flow that is necessary to tumor growth (angiogenesis). In previous clinical trials, bevacizumab was shown to improve early response rates and clinical benefit in patients with recurrent glioblastoma. Other clinical trials have shown that angiogenic agents can be combined with traditional chemotherapies safely and with greater effectiveness. This randomized trial will test whether the addition of lomustine might improve and prolong response.in recurrent glioblastoma.

ID01-310: Phase I Trial of Conditionally Replication-Competent Adenovirus (Delta-24-RGD) for Recurrent Malignant Gliomas
Principal Investigator: Frederick Lang, M.D., FACS

Delta 24-RGD is a virus that has been engineered to 'infect' only cells that lack the Rb tumor suppressor gene, a condition unique to tumor cells. Animal testing showed that the virus does not appear to infect normal cells, no observable toxicities were seen, and 60% of animals treated with the virus were long-term survivors.

2011-0705: Phase I/II Adaptive Randomized Trial of Bevacizumab versus Bevacizumab plus TPI 287 in Adults with Recurrent Glioblastoma
Principal Investigator: Charles A. Conrad, M.D.

The goal of Part I of this clinical research study is to find the highest tolerable dose of TPI 287 that can be given with bevacizumab to patients with glioblastoma. The goal of Part II is to learn if TPI 287 when given with
bevacizumab can help to control glioblastoma better than when bevacizumab is given alone. The safety of the drug combination will also be studied.

TPI 287 is designed to block a protein that causes cancer cells to become resistant to the effects of chemotherapy. By blocking the protein, the drug may be able to cause the cancer cells to shrink or stop growing.

Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels.

Anaplastic Gliomas & Mixed Tumors

Newly Diagnosed

2012-0441: Prospective Assessment of Correlative and Tissue Biomarkers in Glioma Patients
(The PROACTIVE-Glioma Program) - A biomarker-driven program for clinical trial development for newly diagnosed and recurrent glioma patients
Principal Investigator: John F. de Groot, M.D.

The goal of this clinical research study is to collect blood and tumor tissues for biomarker testing from patients with glioma. Biomarkers are found in the blood and tissues and may be related to the body's reaction to the disease
and/or treatment.

Researchers will use these biomarkers to look for and understand factors that may play a role in the development of glioma. Researchers also want to learn about possible genetic changes that may be related to glioma.

RTOG 0834: Phase III trial on Concurrent and Adjuvant Temozolomide chemotherapy in non - 1p/19q deleted anaplastic glioma. The CATNON Intergroup trial
Principal Investigator: John F. de Groot, M.D.

This study is for patients whose tumors do not show co-deletion of chromosome arms 1p and 19q. The study is designed to determine if these patients have improved outcomes if they are treated with radiation therapy together with temozolomide, as compared to patients who do not receive temozolomide during radiation therapy, and if patients receiving temozolomide after radiation therapy have better outcomes than patients who do not receive temozolomide after radiation therapy. Patients must have tumor tissue from a surgery to confirm co-deletion of 1p/19q.

Recurrent

ECOG-E3F05: Phase III Study of Radiation Therapy with or without Temozolomide for Symptomatic or Progressive Low-Grade Gliomas
Principal Investigator: John F. de Groot, M.D.

The goal of this clinical research study is to learn if adding temozolomide to radiation therapy can help to control low-grade glioma better than treatment with standard radiation therapy alone. The safety of this treatment combination will also be studied.

The radiation therapy in this study is designed to stop the reproduction and repair of cancer cells by damaging the DNA (the genetic material of cells). The damaged DNA may cause tumor cell death. Radiation therapy is the commonly used standard of care for low-grade glioma.

Temozolomide is also designed to damage the DNA of cancer cells. The damaged DNA may cause tumor cell death.

ID01-310: Phase I Trial of Conditionally Replication-Competent Adenovirus (Delta-24-RGD) for Recurrent Malignant Gliomas
Principal Investigator: Frederick Lang, M.D., FACS

High-Grade Gliomas

BTTC 11-01: Lacosamide for Seizure Prophylaxis in High-Grade Gliomas
Principal Investigator: Mark R. Gilbert, M.D.

The goal of this clinical research study is to learn if an antiepileptic (anti-seizure) treatment will prevent seizures in patients with brain tumors who have not yet had a seizure. Anti-seizure drugs are designed to decrease abnormal electrical activity in the brain that plays a role in developing seizures.

In this study, lacosamide will be used as an anti-seizure medication. Lacosamide will be compared to a placebo.

A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect. (View PDF of trial information.)

BTTC09-01: A Phase I-II trial everolimus and sorafenib in Patients with Recurrent High-Grade Gliomas
Principal Investigator: Marta Penas-Prado, M.D.

Ependymoma

CERN 08-02: A Phase II Study of Dose-Dense Temozolomide and Lapatinib for Recurrent Low-Grade and Anaplastic Supratentorial , Infratentorial and Spinal Cord Ependymoma
Principal Investigator: Mark R. Gilbert, M.D.

Temozolomide has an established track record and a good safety profile in the treatment of patients with primary brain tumors. The addition of lapatinib will target the ERBB1 (EGFR) and ERBB2 pathways, which are active in a high percentage of ependymomas. This study will also analyze tumor tissue from patients to determine relevant molecular abnormalities.

CERN09-02: Phase II trial of carboplatin and bevacizumab for the treatment of recurrent low-grade and anaplastic supratentorial, infratentorial and spinal cord ependymoma in adults
Principal Investigator: Mark R. Gilbert, M.D.

The goal of this clinical research study is to learn if the combination of bevacizumab and carboplatin can help to control recurrent ependymoma. The safety of this drug combination will also be studied.

ID01-310: Phase I Trial of Conditionally Replication-Competent Adenovirus (Delta-24-RGD) for Recurrent Malignant Gliomas
Principal Investigator: Frederick Lang, M.D., FACS