The Long Island Brain Tumor Center at Neurological Surgery, P.C., is participating in the trials listed below.
To view additional information visit clinicaltrials.gov.
For more information, please contact R. Kimberly Prabhu, MA, CCRP or Kerry McConie RN, OCN at (516) 478-0010
Sponsor: Neurological Surgery, P.C.
Hyperbaric Hyperoxygenation With Radiotherapy and Temozolomide in Adults With Newly Diagnosed Glioblastoma (HBO)
- Standard treatment for glioblastomas includes radiation and chemotherapy with a drug called temozolomide (Temodar); however, glioblastomas frequently develop resistance to standard treatment and recur or progress. Glioblastomas are known to have decreased levels of oxygen compared to normal tissues. There is evidence that these lower oxygen levels in glioblastomas may contribute to their ability to resist treatment effects of radiation and chemotherapy. In this study we will look to increase the oxygen concentration within the glioblastoma by adding hyperbaric treatments (the experimental part of this study) to standard treatment with radiation and temozolomide in order to see whether increasing the oxygen concentration within the tumor increases the tumor-killing ability of standard radiation and chemotherapy.
- In addition, the investigators are interested to evaluate the effect of this treatment protocol on a person's quality of life and level of stress, and, therefore, the investigators will ask subjects to complete several brief questionnaires while they are on-study.
Sponsor: Geron Corporation
A Phase II, Multi-center, Open-label Study Evaluating GRN1005 Alone or in Combination with Trastuzumab in Breast Cancer Patients with Brain Metastases.
- The purpose of this study is to assess the efficacy, safety, and tolerability of GRN1005 in patients with brain metastases from breast cancer. For patients with HER2 positive metastatic breast cancer, GRN1005 will be assessed in combination with Trastuzumab (Herceptin®) as per standard-of-care practice.
Sponsor: Geron Corporation
A Phase II, Multi-center, Open-label Study Evaluating the Efficacy and Safety of GRN1005 in Non-small Cell Lung Cancer Patients with Brain Metastases.
Sponsor: Merck Sharp & Dohme Corp. (Merck)
A Phase III Randomized, Placebo-Controlled, Clinical Trial to Study the Safety and Efficacy of V212 in Adult Patients with Solid Tumor or Hematologic Malignancy
- This is a randomized, double-blind, placebo-controlled study to assess the safety and tolerability of V212 when administered to adults with solid tumor malignancy (STM) or hematologic malignancy (HM) and to determine whether V212 reduces the incidence of herpes zoster (HZ) in adults with STM or HM, as compared to placebo.
Sponsor: Northwest Biotherapeutics, Inc
A Phase II Clinical Trial Evaluating DCVax-Brain, Autologous Dendritic Cells Pulsed with Tumor Lysate Antigen for the Treatment of Glioblastoma Multiforme
- The purpose of the study is to determine the safety and efficacy of an investigational therapy called DCVax(R)-L in patients with newly diagnosed GBM for whom surgery is indicated. Patient must enter screening at a participating site prior to surgical resection of the tumor. Patients will receive standard of care, including radiation and Temodar therapy and two out of three will additionally receive DCVax-L and the remaining one third will receive placebo. Patients randomized to placebo will have the option to receive DCVax-L in a crossover arm upon documented disease progression. (note: DCVax-L when used for patients with brain cancer is sometimes also referred to as DCVax-Brain)
Sponsor: Arno Therapeutics, Inc.
A Phase 2 Study of AR-67 (7-t-butyldimethylsiltyl-10-hydroxycamptothecin) in Adult Patients with Recurrence of Glioblastoma Multiforme (GBM) or Gliosarcoma
- The primary objective of this study is to determine the 6-month Progression free survival (PFS) when intravenous (IV) AR-67 is administered in adults with confirmed recurrence of GBM who have not recently (> 90 days) recurred after treatment bevacizumab (including patients who've received temazolamide, but no bevacizumab). The primary objective in the rapid bevacizumab failure group (< 90 days) is to determine the 2-month PFS.
Sponsor: ImmunoCellular Therapeutics, Ltd.
A Randomized, Double blind, Controlled Phase IIb Study of the Safety and Efficacy of ICT 107 in Newly Diagnosed Patients with Glioblastoma Multiforme Following Resection and Chemoradiation
- This is a phase 2, multicenter study to determine the safety and efficacy of ICT-107 in treating a type of brain tumor called Glioblastoma Multiforme (GBM). ICT-107 is an immunotherapy in which the patient's immune response will be stimulated to kill the tumor cells. Patients must be newly diagnosed with GBM and not yet received chemoradiation. Some of the patient's white blood cells (WBC) will be removed and cultured in a laboratory with purified antigens, similar to those on GBM cells. The patient's own WBC/DC that have been exposed to the tumor antigens will then be given back to the patient as a vaccine over several months. The goal is for the ICT-107 vaccine to stimulate the patient's immune response to kill the remaining GBM tumor cells after surgery and chemotherapy.
Sponsor: Celldex Therapeutics, Inc. CDX110-04
An International, Randomized, Double-Blind, Controlled Study of Rindopepimut/GM-CSF with Adjuvant Temozolomide in Patients with Newly Diagnosed, Surgically Resected, EGFRvIII-positive Glioblastoma(The “ACT IV” Study)
- This 2-arm, randomized, phase III study will investigate the efficacy and safety of the addition of rindopepimut (an experimental cancer vaccine that may act to promote anti-cancer effects in patients who have tumors that express the EGFRvIII protein) to the current standard of care (temozolomide) in patients with recently diagnosed glioblastoma, a type of brain cancer.
- All patients will be administered temozolomide, the standard treatment for glioblastoma. Half the patients will be randomly assigned to receive rindopepimut and half the patients will be randomly assigned to receive a control called keyhole limpet hemocyanin.
- Patients will be treated in a blinded fashion (neither the patient or the doctor will know which arm of the study the patient is on). Patients will be treated until disease progression or intolerance to therapy and all patients will be followed for survival.
Sponsor: Celldex Therapeutics, Inc. CDX110-06
A Phase II Study of Rindopepimut/GM-CSF in Patients with Relapsed EGFRvIII-Positive Glioblastoma
- The purpose of this research study is to find out whether adding an experimental vaccine called rindopepimut (also known as CDX-110) to the commonly used drug bevacizumab can improve progression free survival (slowing the growth of tumors) of patients with relapsed EGFRvIII positive glioblastoma.
Dr Jonathan Brisman and Dr John Pile-Spellman have produced a journal representing six articles in peer-reviewed journals and textbook chapters that have been published by the
NSPC neurovascular team in the last few years. Both Dr. Brisman and Dr. Pile-Spellman have continued in the strong academic
tradition of research and scientific publication because they believe that the complexity of cerebrovascular disease demands it.
In order to continue to advance the field, it is their belief, these illnesses must be studied in depth, the data recorded, analyzed,
reviewed and put down on paper.