(212) 434-3900

130 East 77th Street, 3 Black Hall
New York, New York 10075

Overview

The Department of Neurosurgery at Lenox Hill Hospital treats complex conditions of the brain, nervous system and spine that can have subtle and far-reaching effects on a patients life. Through research and clinical trials, the department is on the cutting edge of innovative surgical techniques and non-surgical treatment options that are safer and more effective.

During the treatment process, our doctors often see opportunities to advance patient care. Working closely with the research staff at the Feinstein Institute for Medical Research, they help develop new and improved diagnostic tools, medications, devices, treatment protocols and more.

Dedicated research centers

  • Brain Tumor Center - Our investigators work within our Brain Tumor Biotech Center, an interactive hub for scientists, clinicians, and biotech companies in the neuro-oncology space at the Feinstein Institute for Medical Research, to accelerate the delivery of novel drugs to patients living with brain tumors.
  • Center for Pituitary and Neuroendocrine Disorders - The center focuses on prolactinomas, acromegaly, Cushing's disease, Rathke's cleft cysts, craniopharyngiomas and other pituitary tumors, as well as hypothalamic tumors and meningiomas
  • Cerebrovascular and Endovascular Neurosurgery Center - Working with investigators at the Feinstein Institute for Medical Research, Dr. Langer has published and presented several studies on carotid revascularization, NOVA flow measurements in AVM patients, and aneurysm clipping outcomes.
  • Spine Center - The laboratory conducts research on stem cell behavior in the disc environment in both healthy and diseased states and examines the role of inflammation and mechanical stress in disc degeneration.

Clinical Trials

For information please contact:

  • Tamika Wong, MPH
  • Clinical Research Manager
  • P: 212.434.4836
  • F: 212.434.3899
  • E: [email protected]

Enrolling


Efficacy and Safety Evaluation of Osilodrostat in Cushing's Disease

PI: John Boockvar, MD

The purpose of this research study is to confirm the effectiveness and safety of osilodrostat in treating patients with Cushing’s disease. Osilodrostat is an investigational drug that has not yet been approved by the Food and Drug Administration (FDA). The safety of the osilodrostat is being tested at different dose levels. Twelve patients with Cushing’s disease have been treated with this study drug for 10 weeks and nineteen patients have been treated for 22 weeks. Results showed that osilodrostat was effective in reducing the cortisol level in all of them. In addition, another large study is ongoing, in which patients will receive osilodrostat for up to 96 weeks.

Osilodrostat is a potent, oral inhibitor of 11β-hydroxylase (CYP11B1), the enzyme that catalyzes the last step in the biosynthesis of cortisol. The current development activity of osilodrostat is focused on the treatment of patients with Cushing’s disease (hypercortisolism due to a pituitary corticotroph adenoma), because it is the most common cause of Cushing’s syndrome and it is a relatively homogeneous patient group. This drug also inhibits aldosterone synthase (CYP11B2), and therefore is a dual inhibitor of both cortisol and aldosterone synthesis. This study is sponsored by the pharmaceutical company named Novartis. Around 69 patients will join this study in approximately 35 centers located in different countries (around 12) across the world.

A Study to Evaluate the Safety, Tolerability and Immunogenicity of EGFR(V)-EDV-Dox in Subjects With Recurrent Glioblastoma Multiforme (GBM) (CerebralEDV)

PI: John Boockvar, MD

The purpose of this research study is to test the safety and tolerability of a new investigational study drug called EGFR(V)-EDV-Dox in the treatment of recurrent glioblastoma multiforme (GBM). EGFR(V)-EDV-Dox is made up of three parts:

  1. The EnGeneIC Delivery Vehicle (EDV). The EDVs are particles made from modified Salmonella bacteria. The type of Salmonella used to make EDVs is one that does not cause disease.
  2. Chemotherapy, in this case doxorubicin, is packaged inside the EDVs.
  3. The EDVs are then coated with a protein called anti-EGFR bispecific antibody. The anti-EGFR bispecific antibody is based on part of the Vectibix® antibody sequence.

EDVs are a new way of delivering drugs for the treatment of cancer because they can be delivered directly to the tumor site. The EDVs attach to epidermal growth factor receptor (EGFR) on the cancer cells. After attaching to the EGFR receptor, the EDVs are taken up inside the cancer cells, and the chemotherapy is delivered directly into the cancer itself. EGFR(V)-EDV-Dox is not approved by the Food and Drug Administration (FDA). Doxorubicin is approved by the FDA for the treatment of more than 10 different types of cancers. It is not approved for use in GBM. Vectibix® is approved by the FDA for the treatmentof some forms of colorectal cancer. It is not approved for use in GBM. The FDA is allowing the use of doxorubicin and a bispecific antibody based on the Vectibix® antibody sequence in this study. A study of EGFR(V)-EDV-Dox in humans has been completed in Australia, and overall the study drug was well tolerated. In this study we want to see if multiple doses of the study drug at two dose levels are safe, and to monitor the side effects (if there are any) at each of these 2 dose levels.

Safety, Tolerability and Efficacy of Disulfiram and Copper Gluconate in Recurrent Glioblastoma

PI: John Boockvar, MD

The purpose of this study is to test the safety, tolerability and efficacy of disulfiram and copper gluconate, in combination with temozolomide in the treatment of recurrent glioblastoma multiforme (GBM). Disulfiram (DSF) is a FDA-approved oral medication that has been used for treating alcoholism since 1951. It inhibits aldehyde dehydrogenase (ALDH), which leads to accumulation of acetaldehyde in the blood after ingestion of alcohol. It has well-known safety profile for up to 3000 mg per day in the absence of alcohol consumption and has been shown to readily cross the blood-brain barrier. Copper gluconate is a dietary food supplement.  The combination of the two drugs, in combination with temozolomide (TMZ), is investigational. Preclinical studies have identified DSF-Cu as having promising activity against GBM cells and can potentially re-sensitize TMZ-resistant cells and orthoptic tumors to TMZ again. A special formulation of both disulfiram and copper gluconate are being produced for Cantex, the Sponsor of the study. Temozolomide (Temodar) will be prescribed by oncologists. This clinical trial of TMZ with the addition of DSF-Cu for TMZ-resistant GBM will provide valuable single-agent efficacy data regarding DSF-Cu and could prospectively validate its potential to re-sensitize GBM to TMZ.

Phase I/II Study of Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM

PI: John Boockvar, MD

The purpose of this study is to evaluate the safety and efficacy of administering the medication capecitabine along with temozolomide for the treatment of your newly diagnosed glioblastoma multiforme (GBM).  Capecitabine is an FDA-approved oral chemotherapy for refractory or relapsed metastatic breast cancer, metastatic colon cancer, and in stage III colon cancer.  Research has been done to show the combination of capecitabine and temozolomide has successfully treated neuro-endocrine tumors with acceptable side effects. Those studies suggest that capecitabine, when given 10 days ahead of temozolomide, helps the temozolomide work better against the cancer cells. The study will evaluate whether the dosage of 1500 mg/m2 of capecitabine is tolerable after radiation, when taken along with temozolomide.  It will also try to determine if the medication capecitabine helps patients respond to treatment for a longer period of time compared to just temozolomide alone, which is the standard of care.

Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma Multiforme (INTRAGO-II)

PI: John Boockvar, MD

The purpose of this study is to find out whether intraoperative radiotherapy (IORT) is more effective at preventing tumor re-growth than standard therapy.  The technique called "intraoperative radiotherapy" (IORT) to treat the tumor cavity with radiotherapy (x-rays) during surgery is investigational. IORT allows high doses of radiation to be delivered directly to the site of the tumor following craniotomy. IORT delivers a large dose of radiation in a single treatment session, while also working to preserve more healthy tissue. This may reduce side effects and the need to return to the hospital for radiation treatments. Subjects will be randomized into two groups: 1) craniotomy only or 2) craniotomy and IORT. In group 2, craniotomy will be followed by the application of a radiation-emitting device that will deliver a 20-30 Gy dose of x-rays into the tumor cavity. The primary objective of the study will examine progression free survival rate following treatment. Secondary endpoints include important aspects of loco-regional and global efficiency (OS, patterns of relapse), prognostic factors (age, KPS, MGMT, etc.), as well as quality of life and safety parameters.

Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma

PI: John Boockvar, MD

The purpose of this study is to evaluate the safety and efficacy of administering repeated doses of cetuximab into the femoral artery when combined with standard of care oral temozolomide for the treatment of newly diagnosed glioblastoma multiforme.  Cetuximab belongs to a class of drugs called epidermal growth factor receptor (EGFR) inhibitors. A percentage of malignant brain tumors, such as glioblastoma multiforme and anaplastic astrocytoma, contain amplified and over-expressed EGFR. There have been few previous studies performed at other institutions using cetuximab for malignant brain tumors. This study is unique in that we are delivering cetuximab through a novel delivery method called Superselective Intra-arterial Cerebral Infusion (SIACI). We hope this allows us to deliver a higher dose of cetuximab to the tumor site, while limiting systemic exposure.

Super Selective Intra-arterial Repeated Infusion of Cetuximab (Erbitux) With Reirradiation for Treatment of Relapsed/Refractory GBM, AA, and AOA

PI: John Boockvar, MD

The purpose of this study is to evaluate the safety and efficacy of administering repeated doses of cetuximab into the femoral artery for the treatment of relapsed or refractory glioblastoma multiforme, anaplastic astrocytoma, or anaplastic oligoastrocytoma. This study will try to determine the proposed regimen of cetuximab administered into arteries repeatedly with re-irradiation is effective.  A superselective intra-arterial dose of cetuximab at 250 mg/m2 will be given on day 1, followed by hypo-fractionated re-radiation 3-5 days later.  A second and third dose of superselective intra-arterial cetuximab at 250 mg/m2 will be given around 21 and 90 days respectively. Cetuximab belongs to a class of drugs called epidermal growth factor receptor (EGFR) inhibitors. A percentage of malignant brain tumors, such as glioblastoma multiforme (GBM) and anaplastic astrocytoma (AA), contain amplified and over-expressed EGFR. There have been few previous studies performed at other institutions using cetuximab for malignant brain tumors. This study is unique in that we are delivering cetuximab through a novel delivery method called Superselective Intra-arterial Cerebral Infusion (SIACI). We hope this allows us to deliver a higher dose of cetuximab to the tumor site, while limiting systemic exposure.

Study of Management of Pasireotide-induced Hyperglycemia in Adult Patients With Cushing's Disease or Acromegaly

PI: John Boockvar, MD

Co-PI: Caroline Messer, MD

The purpose of this research study is to determine the best treatment for hyperglycemia that may occur from receiving the study drug, pasierotide, which is being provided for the treatment of Cushing’s disease or acromegaly. In Cushing’s disease, the tumor of the pituitary gland causes the adrenal glands to secrete an excess of cortisol, leading to many of the disease’s harmful effects. Pasireotide reduces the amount of cortisol produced by the adrenal glands. Pasireotide is approved in Europe and in the USA as a subcutaneous formulation (injected beneath the skin) under the trade name Signifor® s.c. for the treatment of people with Cushing’s disease. Acromegaly is characterized by the overproduction of growth hormone (GH) by the pituitary gland. In over 95% of patients with acromegaly, the disease is caused by a GH-secreting pituitary adenoma (benign or non-cancerous tumor in the pituitary gland). Pasireotide has also been developed as a long-acting release formulation (LAR) for the treatment of acromegaly, which acts by reducing the level of growth hormone in the blood. Pasireotide LAR has been approved by the Food and Drug Administration as an intramuscular injection (injected into the muscle) under the trade name Signifor® LAR for the treatment of people with acromegaly. Hyperglycemia was a frequently observed adverse drug reaction during the pasireotide clinical studies. This study is designed to evaluate the safety and effectiveness of incretin based anti-diabetic therapy (sitagliptin followed by liraglutide) compared to insulin following treatment with pasireotide.

Repeated Super-Selective Intraarterial Cerebral Infusion of Bevacizumab (Avastin) for Treatment of Newly Diagnosed GBM
PI: John Boockvar, MD

This phase I/II clinical research trial will test the hypothesis that repeated dosing of of intra-arterial Bevacizumab at 15 mg/kg can be safely administered to enhance survival of subjects with newly diagnosed Glioblastoma multiforme while they receive standard of care. We expect that this project will provide important information regarding the utility of repeated SIACI Bevacizumab therapy for newly diagnosed malignant glioma, and may alter the way these drugs are delivered to our patients in the future.

Repeated Super-selective Intraarterial Cerebral Infusion of Bevacizumab (Avastin) for Treatment of Relapsed GBM and AA
PI: John Boockvar, MD

This phase I/II clinical research trial will test the hypothesis that repeated direct intraarterial infusion Bevacizumab (15mg/kg) can be safely administered to enhance survival of patients with relapsed/refractory Glioblastoma Multiforme and Anaplastic Astrocytoma. The current standard of care for recurring GBM is for patients to receive Bevacizumab (Avastin) intravenously (IV) at 10mg/kg every two weeks until their tumor grows more than 25%. This study will help investigators determine if IV therapy with Bevacizumab should be combined with repeated selected intra-arterial Bevacizumab to improve progression free and overall survival.

Super-Selective Intraarterial Infusion of Cetuximab (Erbitux) With or Without Radiation Therapy for the Treatment of Unresectable Recurrent Squamous Cell Carcinoma of the Head and Neck
PI: John Boockvar, MD

Co-PI: Peter Costantino, MD and Dennis Kraus, MD

This is an open-label, non-randomized, two arm, Phase I research study of superselective intraarterial Cetuximab (Erbitux) with or without radiation therapy for treatment of recurrent unresectable squamous cell carcinoma of the head and neck (HNSCC). Cetuximab has recently emerged as a promising biological agent in the management of HNSCC. It is an epidermal growth factor receptor (EGFR) inhibitor which increases the radiosensitivity of tumors to radiotherapy (RT), and has been proven to be effective. A large body of evidence supports the theoretical attractiveness of intra-arterial chemotherapy, related to the first pass of the drug through the tumor bed and to the possibility of increasing the doses of the chemotherapeutic agent, thus minimizing systemic toxic side effects. Theoretically, a higher dose of Cetuximab saturating the tumor tissue’s EGFR receptor will increase its responsiveness with or without concurrent radiation therapy.

Super-selective Intra-arterial Cerebral Infusion of Trastuzumab for the Treatment of Cerebral Metastases of HER2/Neu Positive Breast Cancer
PI: John Boockvar, MD

Co-PI: Jonathan Knisely, MD

The purpose of this study is to evaluate the safety of administering a single dose of trastuzumab into your artery for the treatment of your brain metastasis(es) from HER2/neu positive breast cancer. This study will try to determine the best tolerated single dosage of trastuzumab administered into arteries by gradually increasing the dosage given to participants as the study progresses. Early participants will receive a dosage of 1 mg/kg. As more participants enroll into the study, this single dosage will be increased at designated levels up to 8 mg/kg, if it’s determined to be safe to increase. Trastuzumab is a type of antibody, which is a protein used by the body’s immune system to fight against pathogens such as bacteria and viruses. This antibody binds to cell receptors known as the HER2/neu tyrosine kinase receptor. These receptors are expressed in certain cancer subtypes such as breast cancer. By blocking signaling through this HER2/neu receptor, trastuzumab can slow down or stop the over-expression of the HER2/neu protein. Over-expression of HER2/neu has been shown to play a role in the development and progression of certain types of breast cancer. Therefore, by slowing down or stopping the expression of HER2/neu, we hope to slow down or stop the growth of your metastasis(es) and increase the responsiveness to therapy.

The Toca 5 Trial: Toca 511 & Toca FC Versus Standard of Care in Patients With Recurrent High Grade Glioma (Toca5)

PI: John Boockvar, MD

The purpose of this study is to determine if the investigational products, Toca 511 and Toca FC, as a combination treatment is effective (works) and safe, compared to a selected number of approved treatments for brain tumors, called a control treatment. Toca 511 is a live virus that has been built to carry a gene into cancer cells.  This gene carries instructions that cause the cancer cells to turn Toca FC into a drug that may kill the cancer cells.  Toca FC is an investigational extended-release form of flucytosine (5-FC).  Flucytosine is a drug approved to treat fungal infections; however, it is not approved for the treatment of brain tumors.  This study will examine progression free survival with treatment with either Toca 511 and Toca FC combination treatment or the control treatment, and overall survival.

Closed For Enrollment


Super-Selective Intraarterial Cerebral Infusion of Cetuximab (Erbitux) for Treatment of Relapsed/Refractory GBM and AA
PI: John Boockvar, MD

Pivotal Study of the FRED Stent System in the Treatment of Intracranial Aneurysms
PI: Avi Setton, MD
Co-I: David Langer, MD and Rafael Ortiz, MD

Edge Phase 1/2a Multicenter, Controlled, Randomized, Open Label, Dose-Escalation, Safety, Tolerability, and Pharmacokinetic Study Comparing EG-1962 and Nimodipine in Patients with Aneurysmal Subarachnoid Hemorrhage
PI: John Boockvar, MD

Phase I Trial of Super-Selective Intraarterial Cerebral Infusion of Temozolomide (Temodar) for Treatment of Newly Diagnosed Glioblastoma Multiforme and Anaplastic Astrocytoma
PI: John Boockvar, MD

Phase I Trial of Super-Selective Intraarterial Cerebral Infusion of Cetuximab (Erbitux) for Treatment of Relapsed/Refractory Glioblastoma Multiforme and Anaplastic Astrocytoma
PI: John Boockvar, MD

Lenox Hill Neurosurgery

The Feinstein Institute for Medical Research

The researchers at the world-renowned Feinstein Institute for Medical Research are continually making advances in medicine.

Neuro-oncology biotech industry progress report

The Brain Tumor Biotech Center at the Feinstein Institute for Medical Research, in collaboration with Voices Against Brain Cancer, hosted the Brain Tumor Biotech Summit in New York City, June 2015.

Experimental drug treatment offers hope to man with brain cancer

CBSNews.com features Dr. Boockvar’s novel clinical trials for malignant brain tumor.

130 East 77th Street , 3 Black Hall
New York, New York 10075
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