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Clinical Trials

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

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

Last updated 2/14/12

Glioblastoma Multiforme

Newly Diagnosed

RTOG-0825: Phase III Double-Blind Placebo-Controlled Trial of Conventional Concurrent Chemoradiation and Adjuvant Temozolomide Plus Bevacizumab Versus Conventional Concurrent Chemoradiation and Adjuvant Temozolomide in Patients with Newly Diagnosed Glioblastoma
Principal Investigator: Mark Gilbert, M.D.

The goal of this clinical study is to find out if adding bevacizumab to the combination of temozolomide and radiation will help to control glioblastoma better than treatment with temozolomide and radiation alone. Researchers will study if the genetic pattern in the tumor cells is related to each participant's response to the bevacizumab and the overall outcome. The safety of these 2 combination treatments will also be studied.

2008-0059: A Phase I/II Study of Sorafenib with Radiation and Temozolomide in Newly Diagnosed Glioblastoma or Gliosarcoma
Principal Investigator: Howard Colman, M.D.

The goal of this clinical research study is to find the highest tolerable dose of sorafenib that can be given in combination with temozolomide. Sorafenib is designed to stop cell growth and to block the formation of new blood vessels that are involved in the growth and development of tumors.  Temozolomide is designed to kill cancer cells by damaging DNA. The damaged DNA may cause tumor cell death. The safety of this combination will also be studied.

2008-0318: Phase I/II Trial of Dasatinib (Sprycel) with Radiation Therapy and Concomitant and Adjuvant Temozolomide in Patients with Newly-Diagnosed Glioblastoma
Principal Investigator: John de Groot, M.D.

Dasatinib has been shown in laboratory studies to reduce tumor cell growth and invasion, and preliminary clinical studies showed the drug to be well tolerated, with preliminary reports of response. Other laboratory studies suggest that combining dasatinib and temozolomide may be effective. The Phase I portion of the study will define the maximum tolerated dose of dasatinib (Sprycel) when administered with radiotherapy and 6 weeks of concomitant temozolomide. The Phase II portion of the study will determine the effectiveness of dasatinib with radiotherapy and 6 weeks of concomitant temozolomide, followed by adjuvant temozolomide with concurrent dasatinib, in patients with newly-diagnosed glioblastoma.

NABTC 07-01: Aflibercept (VEGF Trap) with Radiation Therapy and Concomitant and Adjuvant Temozolomide in Patients with Malignant Glioma
Principal Investigator: John de Groot, M.D.

The goal of this clinical study is to find the highest tolerable dose of VEGF Trap that can be given in combination with temozolomide during and after radiation therapy. The safety of this combination will also be studied. In addition, this study will study response to VEGF Trap therapy in relation to various markers in the tumor molecular profile, and evaluate the effect of treatment with VEGF Trap, temozolomide, and radiation therapy on neurocognitive outcomes in patients.

2009-0476: A Phase 1 Dose Finding Study of the Safety and Pharmacokinetics of XL184 Administered Orally in Combination with Temozolomide and Radiation Therapy in the First Line Treatment of Subjects with Glioblastoma
Principal Investigator: John de Groot, M.D.

XL184 is a small molecule designed to inhibit c-MET and VEGFR2, which have been shown to contribute to brain tumor growth and the formation of blood vessels that support tumor growth. In combination with radiation and temozolomide, it may increase response, while reducing potential side effects of radiation therapy such as brain edema and late radiation necrosis. 

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.

BTTC08-01:  A Phase II study of Bevacizumab and Erlotinib after Radiation Therapy and Temozolomide in patients with newly diagnosed glioblastoma without MGMT promoter methylation
Principal Investigator: John de Groot, M.D.

Studies have shown that radiation therapy can activate certain growth factors, including EGFR and VEGF, that help cancer cells survive. EGFR and VEGF inhibitors may be effective after radiation therapy, when VEGF expression and EGFR activation may be greatest, to counteract this resistance. Patients whose MGMT promoter is not silenced were selected for this study, because they do not respond as well to temozolomide treatment, when compared to patients with silenced MGMT promoter. 

NABTC 04-03: Vorinostat (Suberoylanilide Hydroxamic Acid {SAHA}) in Combination with Temozolomide in Patients with Malignant Gliomas
Principal Investigator: Vinay Puduvalli, M.D.

The goal of this clinical study is to find the highest tolerated dose of vorinostat (SAHA) that can be given in combination with temozolomide, without causing severe side effects in most patients with malignant glioma. This study will also explore the association of response to treatment to the molecular profile of the tumor.

2009-0476: A Phase 1 Dose Finding Study of the Safety and Pharmacokinetics of XL184 Administered Orally in Combination with Temozolomide and Radiation Therapy in the First Line Treatment of Subjects with Glioblastoma
Principal Investigator: John de Groot, M.D.

XL184 is a small molecule designed to inhibit c-MET and VEGFR2, which have been shown to contribute to brain tumor growth and the formation of blood vessels that support tumor growth. In combination with radiation and temozolomide, it may increase response, while reducing potential side effects of radiation therapy such as brain edema and late radiation necrosis.

Recurrent

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. 

2010-0856: Phase I Study of MK-4827 in Combination with Temozolomide in Patients wtih Advanced Cancer 
Principal Investigator: Razelle Kurzrock, M.D.

The goal if the study is to find the highest tolerable does of the combination of MK-4827 and temozolomide that can be given to patients with advanced solid cancers. The effects of the MK-4827 at different dose levels and the safety of the drug will also be studied. Patients will also be asked to take part in optional procedures, which are described in a separate consent form.   

2006-0709: Phase I/II Adaptive Randomized Trial of Vorinostat, Isotretinoin and Carboplatin in Adults with Recurrent Glioblastoma Multiforme
Principal Investigator: Vinay K. Puduvalli, M.D.

The goal of this clinical study is to find the highest safe dose of vorinostat, a histone deacetylase inhibitor, when given with Accutane (isotretinoin) and carboplatin to patients with malignant gliomas.  Isotretinoin has shown activity against gliomas: vorinostat may interfere with the resistance to isotretinoin treatment that tumor cells often develop. The addition of carboplatin may also enhance antitumor activity. The safety and effectiveness of this drug combination will be studied.  The study design includes 'adaptive randomization', which adjusts the probability of a patient being assigned to a particular study arm to reflect the interim results of the trial.

2009-0759: A Phase 2 Open-Label Study of the Efficacy of TPI 287 in Patients with Glioblastoma Multiforme That Has Recurred or Progressed Following Prior Therapy with Radiation plus Temozolomide
Principal Investigator: Charles Conrad, M.D.

TPI 287 is a new agent that has been designed to overcome  tumor cell mechanisms of chemotherapy resistance. In laboratory animal it was more potent against cancer cells than previous similar drugs. The drug has been shown to penetrate the brain, and in phase I testing, patients experienced few or no side effects. This study is designed to determine the effectiveness of TPI 287 in patients with recurrent or progressive glioblastoma.

2006-0472: Irinotecan plus Lenalidomide in Adult Patients with Recurrent Glioblastoma Multiforme
Principal Investigator: Vinay K. Puduvalli, M.D.

Lenalidomide is similar to thalidomide, but is several times more potent as an anti-angiogenic agent without toxicities associated with thalidomide. The goal of the Phase I study is to find the highest safe dose of Irinotecan plus Lenalidomide in patients with malignant gliomas. The Phase II study will determine the effectiveness of this combination against gliomas.

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 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.

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. 

RTOG 0627: Dasatinib in Patients with Recurrent Glioblastoma Multiforme
Principal Investigator: Mark Gilbert, M.D.

The goal of this Phase II study is to learn if dasatinib can help to control glioblastoma multiforme that has come back after treatment with radiation therapy and temozolomide. The safety of this drug will also be studied.

Anaplastic Gliomas & Mixed Tumors

2006-0709: Phase I Adaptive Randomized Trial of Vorinostat, Isotretinoin and Carboplatin in Adults with Recurrent Glioblastoma Multiforme
Principal Investigator: Vinay K. Puduvalli, M.D.

The goal of this clinical study is to find the highest safe dose of vorinostat, a histone deacetylase inhibitor, when given with Accutane (isotretinoin) and carboplatin to patients with malignant gliomas.  Isotretinoin has shown activity against gliomas: vorinostat may interfere with the resistance to isotretinoin treatment that tumor cells often develop. The addition of carboplatin may also enhance antitumor activity. The safety and effectiveness of this drug combination will be studied.  The study design includes 'adaptive randomization', which adjusts the probability of a patient being assigned to a particular study arm to reflect the interim results of the trial.

NABTC 07-01: Aflibercept (VEGF Trap) with Radiation Therapy and Concomitant and Adjuvant Temozolomide in Patients with Malignant Glioma
Principal Investigator: John de Groot, M.D.

The goal of this clinical research study is to study the safety and find the highest tolerable dose of VEGF Trap that can be given in combination with temozolomide during and after radiation therapy. VEGF Trap is a protein that acts as a decoy receptor for VEGF and depletes circulating VEGF to inhibit angiogenesis.  In addition, this study will study response to VEGF Trap therapy by various markers in the tumor molecular profile, and evaluate the effect of treatment with VEGF Trap, temozolomide, and radiation therapy on neurocognitive outcomes in patients.

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

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.  

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 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.

Ependymoma

2008-0694: (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 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.

Meningioma

RTOG 0539: Phase II trial of observation for low-risk meningiomas and of radiotherapy for intermediate and high-risk meningiomas
Principal Investigator: John de Groot, M.D.

This study is designed to deliver the optimum standard of care for all patients, while extending the understanding of meningiomas that progress after surgery (intermediate risk), and meningiomas that progress after surgery and radiation (high risk). Over the course of the study, information will be gathered each for each of the three risk categories about tumor size after surgery, imaging characteristics of the tumor, and significant molecular characteristics.

Leptomeningeal Metastases

2009-0122: A Pilot Study of Systemically Administered Bevacizumab in Patients with Neoplastic Meningitis (NM)
Principal Investigator: Morris Groves, M.D.

The goal of this clinical research study is to learn if and how Avastin (bevacizumab) may affect cancer that has spread to the meninges of the brain or the spinal cord. The safety of this drug will also be studied.

Treatment at MD Anderson

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