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RESEARCH

OPEN CLINICAL TRIALS

The Long Island Brain Tumor Center at Neurological Surgery, P.C.
Neuro-Oncology Research

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

Newly Diagnosed Glioblastoma

  • 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. 
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  • Sponsor: Northwest Biotherapeutics
    A Phase III 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®-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)
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  • Sponsor: ImmunoCellular Therapeutics, Ltd. (Closed for new enrollments)
    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 II, 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.
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  • Sponsor: Celldex Therapeutics CDX110-04 (Closed for new enrollments)
    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.
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Recurrent Glioblastoma

  • Sponsor:  Cortice Biosciences, Inc
    Phase II Dose-Escalation Study of TPI 287 in Combination with Bevacizumab in Adults with Recurrent Glioblastoma Safety and Efficacy Study of TPI 287 in Combination With Avastin (Bevacizumab) to Treat Glioblastoma

    The purpose of this study is to determine the safety, maximum tolerated dose (MTD), and efficacy of TPI 287 in combination with Avastin (bevacizumab) in subjects who have glioblastoma multiforme (GBM) that has recurred or progressed following prior radiation therapy and temozolomide (TMZ).
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  • Sponsor:  NovoCure Ltd.
    A Prospective, Non-Randomized, Concurrent Control, Open Label, Post-Approval Study of NovoTTF-100A in Recurrent GBM Patients - Post Approval Study for PMA Approval P100034

    This is a non-randomized, concurrent control study, designed to confirm that the efficacy of the NovoTTF-100A System in patients with recurrent GBM treated in a real life settings following approval is comparable to that of BSC chemotherapy patients. The device is a portable, battery operated device that was approved for the treatment of adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM), following histologically- or radiologically-confirmed recurrence in the supra-tentorial region of the brain after receiving chemotherapy. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted.
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  • Sponsor: Celldex Therapeutics CDX110-06 (Closed for new enrollments)
    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.
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All Solid Tumors

  • 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.            
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Recurrent Brain Metastases

  • Sponsor:  Angiochem Inc.
    A Phase II, Open-Label, Multi-Center Study of ANG1005 in Breast Cancer Patients with Recurrent Brain Metastases.

This is a Phase II study to see if an investigational drug, ANG1005, can shrink tumor cells in breast cancer patients with recurrent brain metastases.            
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Expanded Access

(COMPASSIONATE USE)
  • Sponsor:  Northwest Biotherapeutics
    An Expanded Access Protocol for the Treatment of Glioblastoma Multiforme in Patients with Already Manufactured DCVax®-L, Autologous Dendritic Cells Pulsed with Tumor Lysate Antigen Who Have Screen-Failed Protocol 020221

The study is an open-label expanded access study for patients for whom vaccine was manufactured during the Northwest Biotherapeutics' 020221 DCVax®-L for GBM screening process, but who subsequently failed to meet specific enrollment criteria. Patients will receive therapy per investigator discretion (standard of care) as well as active vaccine per the 020221 protocol administration schedule. It is estimated that approximately 99 patients will enroll in this study.   
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  • Sponsor: Celldex Therapeutics, Inc
    TREATMENT PROTOCOL-RINDOPEPIMUT (CDX-110-05)

The study is an open-label expanded access study for patients who do not qualify for Celldex currently enrolling studies.

 

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