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.
(updated 9/1/2009)
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)
- Ependymoma
- Brain Metastases
- Leptomeningeal Metastases
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, MD
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, MD
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.
NABTC 07-01: Aflibercept (VEGF Trap) with Radiation Therapy and Concomitant and Adjuvant Temozolomide in Patients with Malignant Glioma
Principal Investigator: John de Groot, MD
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.
After Radiation Therapy
2004-0662: Temozolomide Alone and In Combination with Possible Premutations of Thalidomide, Isotretinoin and/or Celecoxib as Post-Radiation Adjuvant Therapy of Glioblastoma Multiforme.
Principal Investigator: Mark Gilbert, MD
Research Nurse: Kathy Hunter, RN
The goal of this clinical study is to learn if Temodar (temozolomide), when given alone or in combination with THALOMIDTM (thalidomide), Accutane (isotretinoin), and/or Celebrex (celecoxib), is effective in treating newly diagnosed glioblastoma multiforme in patients who have already received radiation therapy. The safety of these treatments 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.
NABTC 04-03: Vorinostat (Suberoylanilide Hydroxamic Acid {SAHA}) in Combination with Temozolomide in Patients with Malignant Gliomas
Principal Investigator: Vinay Puduvalli, MD
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.
Recurrent
2006-0709: Phase I/II Adaptive Randomized Trial of Vorinostat, Isotretinoin and Carboplatin in Adults with Recurrent Glioblastoma Multiforme
Principal Investigator: Vinay K. Puduvalli, MD
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.
2007-0931: Phase 1 Open-Label Dose Excalation Study of ANG1005 in Patients with Malignant Glioma
Principal Investigator: Morris Groves, MD, JD
ANG1005 is a combination of paclitaxel (Taxol) and Angiopep2. Angiopep2 is a peptide designed to help drugs cross the brain blood barrier. When ANG1005 is transported across the brain blood barrier and reaches the cancer cells, it is internalized to release paclitaxel. ANG1005 has been shown to inhibit tumor cell proliferation, and block progression of tumor cells through the cell cycle. This clinical study will confirm the safety and maximum tolerated dose of ANG1005, study how well ANG1005 reaches tumor cells and whether it produces an immune response.
2006-0472: Irinotecan plus Lenalidomide in Adult Patients with Recurrent Glioblastoma Multiforme
Principal Investigator: Vinay K. Puduvalli, MD
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.
RTOG 0627: Dasatinib in Patients with Recurrent Glioblastoma Multiforme
Principal Investigator: Mark Gilbert, MD
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.
NABTC 05-02: BAY 43-9006 (sorafenib) in Combination with OSI-774 (erlotinib), R115777 (tipifarnib) or CCI-779 (temsirolimus) in Patients with Recurrent Glioblastoma Multiforme or Gliosarcoma
Principal Investigator: Mark Gilbert, MD
The goal of this Phase I/II study is to study the safety and effectiveness of combinations of BAY 43-9006 and either OSI-774 (erlotinib), R115777 (tipifarnib), or CCI-779 (temsirolimus), that can be given to treat patients with brain glioblastoma or gliosarcoma that has come back after treatment. Researchers also will study the relationship between tumor biomarkers in blood and tumor tissue, as well as patient responses to the treatment combinations.
2007-0671: A Phase III, Randomised, Parallel Group, Multi-Centre Study in Recurrent Glioblastoma Patients to Compare the Efficacy of Cediranib [RECENTIN™, AZD2171] Monotherapy and the Combination of Cediranib with Lomustine to the Efficacy of Lomustine Alone
Principal Investigator: John de Groot, M.D.
Cediranib is a small molecule inhibitor of VEGF signaling, and preliminary data from a phase II study showed biological activity against glioblastoma. This study will compare its effectiveness as a single agent to the effectiveness of lomustine alone and the effectiveness of the two agents used in combination.
2007-0491: CT-322 (Angiocept™) monotherapy and combination therapy with irinotecan in patients with recurrent glioblastoma multiforme
Principal Investigator: John de Groot, MD
CT-322 is a high-affinity blocker of VEGFR-2 and blocks all known ligands of this critical tumor angiogenesis receptor, including VEGF-A, C, and D. CT-322 also has limited toxicity in clinical and preclinical studies. Bevacizumab does not bind to or block the action of VEGF-C and D, and which suggests a potential for enhanced efficacy with CT-322.
2007-0816: XL184 in Subjects with Progressive or Recurrent Glioblastoma Multiforme in First or Second Relapse
Principal Investigator: John de Groot, MD
The goal of this clinical research study is to learn if XL184 can help to control glioblastoma. The safety of XL184 will also be studied.
2007-0286: Recurrent/Relapsed Glioblastoma Multiforme with MPC-6827 in Combination with Carboplatin
Principal Investigator: John de Groot, MD, JD
MPC-6827 is a small molecule inhibitor of microtubule assembly. In animal models it readily crosses the blood-brain barrier and disrupts tumor blood vessels. The goal of this clinical research study is to find the highest tolerable dose of a combination of drugs (MPC-6827 and carboplatin) for brain glioblastoma. The safety of this combination of drugs 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.
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.
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, MD
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, MD
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.
2007-0931: Phase 1 Open-Label Dose Excalation Study of ANG1005 in Patients with Malignant Glioma
Principal Investigator: Morris Groves, MD, JD
ANG1005 is a combination of paclitaxel (Taxol) and Angiopep2. Angiopep2 is a peptide designed to help drugs cross the brain blood barrier. When ANG1005 is transported across the brain blood barrier and reaches the cancer cells, it is internalized to release paclitaxel. ANG1005 has been shown to inhibit tumor cell proliferation, and block progression of tumor cells through the cell cycle. This clinical study will confirm the safety and maximum tolerated dose of ANG1005, study how well ANG1005 reaches tumor cells and whether it produces an immune response.
Ependymoma
2008-0694: 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, MD
Brain Metastases
ID00-377: Comparing Radiosurgery with vs. without Whole Brain Radiotherapy for 1-3 Newly Diagnosed Brain Metastases
Principal Investigator: Eric Chang, M.D.
Research Nurse: Leni A. Mathews, RN
This prospective Phase III randomized trial is designed to address the question of whether patients with 1-3 brain metastases treated with radiosurgery should receive immediate or delayed WBRT. In addition, the trial will seek to determine the optimum strategy for salvage therapy in the group of patients treated with SRS alone who have recurred within the brain by performing a secondary randomization which will compare freedom from progression in patients treated with salvage local therapy (SRS and/or surgery) versus salvage WBRT.
Leptomeningeal Metastases
2009-0122: A Pilot Study of Systemically Administered Bevacizumab in Patients with Neoplastic Meningitis (NM)
Principal Investigator: Morris Groves, MD
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.