Neuro Clinical Trials
Newly Diagnosed
Phase I/II - Study of the Poly (ADP-ribose) Polymerase-1 (PARP-1) Inhibitor BSI-201 in Patients with Newly Diagnosed Malignant Glioma. MCC 15412/ABTC 0703
Summary: PARP-1 (BSI-201) is an enzyme that regulates DNA repair after injury from alkylating agents or ionizing radiation, and also regulates several cellular processes such as proliferation, differentiation and cell death, which are reported to contribute to glioma growth. While the PARP family of proteins is overexpressed in malignant gliomas, it appears to be expressed at low levels in normal tissues, making it an attractive target for glioma therapy. Inhibition of PARP is expected to increase chemoradiation-induced cell death and is administered by IV infusion twice per week for 2 days in a row, for at least 6 months. Patients enrolled in this trial must have their IV infusions given at Moffitt Cancer Center.
PI: Ed Pan, MD
Coordinator: Pam Smith 813-745-3951
Phase II - Clinical Trial Evaluating DC Vax-Brain, Autologous Dendritic Cells Pulsed with Tumor Lysate Antigen for the Treatment of Glioblastoma Multiforme. MCC 15160/Northwest Biotherapeutics
Summary: This study uses personalized immunotherapy designed to stimulate a patient's own immune system to attack the glioblastoma cells. Dendritic cells (DC) from the patient's peripheral blood mononuclear cells (PBMC) obtained by leukapheresis, are mixed with the resected tumor in a lab to expose and 'educate' them to biomarkers in the patient's tumor. The vaccine (combination of DC and tumor lysate) is then injected back into the patient which mobilizes their immune system to recognize and destroy remaining glioblastoma cells. The vaccine injections are given intradermally (up to 10 doses) in the upper arm, in combination with temozolomide (TMZ) and radiation therapy (XRT).
PI: Steven Brem, MD
Coordinator: Shirley Entis 813-745-3929
Comments: Temporarily closed to accrual
Phase III - Cilengitide for Subjects with Newly Diagnosed Glioblastoma Multiforme and Methylated MGMT Gene Promoter - A Multicenter, Open-label, Controlled Phase III Study, Testing Cilengitide in Combination with Standard Treatment (Temozolomide with Concomitant Radiation Therapy, followed by Temozolomide Maintenance Therapy) Versus Standard Treatment Alone (CENTRIC). MCC 15635/Serono 121974-011
Summary: New cancer treatments based on better understanding of the biology are continuously being developed. One such new drug, cilengitide is targeting not only the tumor cells, but also and in particular the blood vessels supplying the tumor with nutrients and oxygen. This new agent has shown some promising activity in preliminary studies in patients with recurrent brain tumors as well as in combination with standard chemo- and radiotherapy in patients newly diagnosed glioblastoma. This study aims at determining whether the addition of cilengitide in combination with standard treatment prolongs life in patients with glioblastoma. Similarly, the duration of response of the cancer to this treatment, the side effects of the therapy and the impact on your quality of life will be analyzed. In addition further data on how well cilengitide is tolerated by the body and how the body deals with this substance will be collected.
PI: Ed Pan, MD
Coordinator: Pam Smith 813-745-3951
Phase I/II - Trial of Hydroxychloroquine in Conjunction with Radiation Therapy and Concurrent and Adjuvant Temozolomide in Patients with Newly Diagnosed Glioblastoma Multiforme. MCC 15281/NABTT 0603
Summary: Hydroxychloroquine (HCQ) is being evaluated as an inhibitor of therapy-induced autophagy. Autophagy is a cancer cell's adaptive response to cytotoxic and radiation treatment therapies. Blocking autophagy makes the glioma cells more sensitive to these treatments, therefore improving the outcomes for patients. HCQ is given in combination with temozolomide (TMZ) and radiation (XRT). HCQ is an FDA-approved drug that has been used for decades to treat patients with rheumatoid arthritis and systemic lupus erythematosis, without significant adverse effects. HCQ is an oral drug given daily so long as patients tolerate it and there is no tumor progression. Patients enrolled in this trial must receive the HCQ therapy through the pharmacy at Moffitt Cancer Center.
PI: Ed Pan, MD
Coordinator: Pam Smith 813-745-3951
Phase Pilot - Single Arm Pilot Study of intrathecally Administered DepoCyt with Systemic Sorafenib in the Treatment of Neoplastic Meningitis from Solid Tumors. MCC 15783/Bayer ISS000266
Summary:
PI: Ed Pan, MD
Coordinator: Pam Smith 813-745-3951
Recurrent
Phase II - Trial of Sutent (Sunitinib; SU011248) for Recurrent Anaplastic Astrocytoma and Glioblastoma Multiforme. MCC 14916/Pfizer 2005-1136
Summary: Sutent (sunitinib) is a small molecule, multi-targeted tyrosine kinase inhibitor (PDGFR, VEGFR, KIT, FLT3). Tyrosine kinases are enzymes involved with several cellular processes and are known to be activated in cancer cells to drive growth. Sutent is administered orally.
PI: Ed Pan, MD
Coordinator: Pam Smith 813-745-3951
Affiliates: Moffitt South
Phase I - Trial of Vorinostat in Combination with Bevacizumab and Irinotecan in Recurrent Glioblastoma. MCC 15629/Merck
Summary: Vorinostat, a small molecule histone deacetylase (HDAC)-inhibitor, has been shown to have activity in glioblastoma cell lines. Preclinical data suggests the potential for HDAC-inhibitors to enhance the cytotoxic effects of topoisomerase I/II and angiogenesis inhibitors. This molecule is being evaluated in combination with bevacizumab (Avastin; anti-VEGF antibody) and irinotecan (CPT-11; topoisomerase-1 inhibitor). Vorinostat is given orally, while bevacizumab and irinotecan are administered IV.
PI: Prakash Chinnaiyan, MD
Coordinator: Pam Smith 813-745-3951
Metastases
Phase II - Multicenter Exploratory Study Evaluating the Treatment Effect of Surgery Plus GLIADEL® Wafers in Patients with Metastatic Brain Cancer. MCC 15272/GLIA-001 MGI
Summary: This study will evaluate the use of GLIADEL® wafers in patients with a single, resectable metastatic brain tumor. Gliadel wafers are small, dime-sized biodegradable polymer wafers designed to deliver carmustine (BCNU) directly into the surgical cavity created when a brain tumor is surgically removed. Once implanted, GLIADEL®slowly dissolves, releasing high concentrations of BCNU into the tumor site. The specificity of GLIADEL® minimizes drug exposure to other areas of the body.
PI: Steven Brem, MD
Coordinator: Shirley Entis 813-745-3929
Phase I - Study of Bendamustine with Concurrent Whole Brain Radiation Therapy in Patients with Brain Metastases from Solid Tumors . MCC 15690/NCCN
Summary: ... coming soon
PI: Ed Pan, MD
Coordinator: Pam Smith 813-745-3951
Affiliates: Moffitt South
Spine
No studies available at this time...
Surgical
Phase II - An Exploratory Study Evaluating the Efficacy and Safety of Fibrin Sealant, Vapor Heated, Solvent/Detergent Treated (FS VH S/D) 500 s-apr for the Sealing of Dura Defect Sutures in Posterior Fossa Surgery. MCC 15714/Baxter 550701
Summary: The space between the dura and the brain is filled with cerebral spinal fluid called CSF. The use of a sealant on top of the sutures (the stitches) used to close the opening in the dura may help control CSF leakage after your surgery. The product to be studied, Fibrin Sealant, Vapor Heated, Solvent/Detergent 500 s-apr (FS VH S/D 500 s-apr), is a fibrin sealant known as a surgical “glue” made out of two substances naturally found in the human body, thrombin and fibrinogen. When mixed together, they form a clot. The human body naturally absorbs the clot over a period of about 14 days. The main purpose of this study is to see if FS VH S/D 500 s-apr works in controlling CSF leakage after brain surgery. This study will also look at the occurrence of infection, adverse events, and procedures required to treat CSF leakage after surgery. FS VH S/D 500 s-apr is already licensed in the USA for use in heart, spleen and bowel surgery and marketed under the name TISSEEL. An earlier form of FS VH S/D 500 s-apr is called TISSEEL VH and it is used in Canada for heart, musculoskeletal, abdominal, chest, urinary surgeries. FS VH S/D 500 s-apr is not licensed in Canada. In several other countries, FS VH S/D 500 s-apr is already approved for sealing of dura sutures(the stitches). Because FS VH S/D 500 s-apr is not approved by the FDA for sealing dura sutures in the USA and not approved by Health Canada for sealing dura sutures(the stitches) in Canada, it is only available by participating in this study.
PI: Frank D Vrionis, MD
Coordinator: Shirley Entis 813-745-3929
For more detailed information on these trials, and to determine eligibility, please contact the Clinical Research Coordinator responsible for the specific trial.
updated 8/20/2009