Kenneth R. Peak Brain & Pituitary Treatment Center Research Labs Clinical Trials

Peak Center Director’s Clinical Trials
A number of clinical trials have been conducted and are available at the Peak Center. David S. Baskin, MD is the Principal Investigator in these trials, along with our Peak Center Neuro-Oncololgist, Ivo Tremont, MD. These trials include national multicenter trials with great promise, as well as Center and Investigator initiated trials, as a result of efforts in the Peak Center Laboratories.

Many other projects in the Peak Center Laboratories are near clinical trials, as our motto is to bring treatments from the bench to the bedside. What follows is a list of each trial with a brief description of that it entails.  If it is active and enrolling, a link to clinicaltrials.gov is included.  If there is no link, inquiries can be made about these evolving research efforts to dbaskin@houstonmethodist.org

Clinical Trials
The Kenneth R. Peak Brain & Pituitary Tumor Treatment and Research at Houston Methodist Hospital provides world-class personalized neurosurgical and oncological treatments for patients with brain, spine and pituitary tumors in a compassionate environment geared toward scientific advances, education and research. Virtually all tumors of the pituitary gland can be removed surgically or reduced in size with other means, and prognosis for patients is excellent.

Glioblastoma (GBM), on the other hand, is very different and there are not many treatment options available. The standard treatment for glioblastoma involves a combination of removing as much of the tumor as possible during surgery, followed by radiation therapy (radiotherapy) and chemotherapy (namely temozolomide). Unfortunately, even after these treatments, the tumor almost universally recurs. The Peak Center for Brain & Pituitary Tumors is dedicated to finding a more effective treatment for all brain tumors than the options that are currently available.
A phase 2/3 randomized, open label study of Toca 511, a retroviral replicating vector, combined with Toca FC versus standard of care in subjects undergoing planned resection for recurrent glioblastoma or anaplastic astrocytoma NCT02414165

Principal Investigator(s)
David S. Baskin, MD, FACS, FAANS

Sponsor
Tocagen Inc.

Summary
This study is a phase 2/3 multicenter, randomized, open-label, gene therapy study to evaluate Toca 511 (the treatment that will be injected into the brain around the place where the tumor was removed) and Toca FC, which is a daily pill. Subjects in this research study are enrolled because they have decided to have surgery to remove a brain tumor that has recurred or progressed after treatment. During this study, subjects are randomized to receive the experimental treatment or standard of care. The purpose of this study is to determine if treatment with Toca 511 and Toca FC will increase overall survival rate in subjects, compared to patients treated with standard of care therapy. Toca FC, also known as flucytosine (5-FC) is a drug approved by FDA to treat fungal infections. Toca 511 is a live murine leukemia virus that has been built to carry the cytosine deaminase gene into cancer cells. This is called gene transfer. This gene carries instructions that cause the cancer cells to make cytosine deaminase, which converts the Toca FC that study subjects will be given into 5 FU, a potent chemotherapeutic agent that kills the cancer cells. Participants will have Toca 511 injected into the wall of the tumor resection site (40 separate injections) and then take Toca FC orally. The study will follow participants for up to 15 years after the initial treatment. This study will compare Toca 511 with Toca FC to standard of care for treatment of recurrent glioblastoma or recurrent anaplastic astrocytoma.

A registry of Caris Life Sciences® Molecular Intelligence™ Service (biomarker assessment results) intended for correlation with cancer clinical outcomes

Principal Investigator(s)
David S. Baskin, MD, FACS, FAANS

Sponsor
Caris Life Science Inc.

Summary
The purpose of this study is to increase our understanding of, and evaluate the clinical outcomes of brain tumor patients who have had the Caris Molecular Intelligence™ Services. This is a data collection study in which we characterize the DNA of the tumor, looking at almost 600 genes known to be associated with brain cancer. The study participants will be asked to provide follow-up information on their progress every nine months for up to five years. A sample of the participant’s tumor tissue collected for diagnostic purposes as part of the standard of care will be sent to undergo the Caris Molecular Intelligence™ Services, which will characterize that status of almost 600 genes known to play an important role in brain and other cancers. The results will be used to determine the best chemotherapeutic options for disease treatment for a specific type of tumor for each subject. These research studies will hopefully result in a change in disease treatment and provide improvement of care by providing personalized medicine and tailoring a patient’s treatment to the specific changes in DNA seen in their tumor.

A phase III clinical trial evaluating DCVax®-L, autologous dendritic cells pulsed with tumor lysate antigen for the treatment of glioblastoma multiforme (GBM)

Principal Investigator(s)
David S. Baskin, MD, FACS, FAANS

Sponsor
Northwest Biotherapeutics Inc.

Summary
This trial, involving approximately 350 subjects, is aimed at gaining further understanding of, and at developing new treatments for brain cancer. The DCVax®-L treatment is a dendritic cell vaccine designed to increase the immune system’s response to cancer, which may lead to new treatment options. In addition to tumor sample, dendritic cells (DC, a type of white blood cell) will be shipped to a laboratory where the DCs will be purified and grown to prepare a tumor vaccine. The cells are then administered to the patient via injection. DCs may be able to teach the immune system to recognize and destroy cancer cells. When the vaccine is injected back into the body it may activate the immune system to destroy brain cancer cells. The study has the potential to improve outcome for glioblastoma patients.

Identification of nutrient energy sources for cancer growth


Principal Investigator(s)
Kumar Pichumani, PhD

Sub-Investigator
David S. Baskin, MD, FACS, FAANS

Sponsor
Kenneth R. Peak Brain & Pituitary Treatment Center at Houston Methodist Hospital

Summary
The primary objective of this study is to determine the sources of energy for the growth of pituitary and brain tumors. Participants in the study have been recommended to undergo surgery to remove a tumor. Glucose and acetate are naturally present compounds in human body metabolism. In order to detect the fate of these two compounds in cancer, these compounds are enriched with carbon-13C, nonradioactive, stable naturally occurring isotope and given to patients intravenously before the surgery in the preoperative surgery area. The infusion will take place continuously (approximately for three hours) until the tumor is removed. The labelled compounds of glucose and acetate can be detected and tracked by MR spectroscopy when the piece of tumor that was removed and frozen is later analyzed. The results of this study will characterize the metabolism of glucose and acetate in brain tumors. The outcome of this study will provide knowledge that will help design drugs targeted at these molecules.

A randomized, multicenter, Phase 2 study of DSP-7888 Dosing Emulsion in combination with Bevacizumab versus Bevacizumab alone in patients with recurrent or progressive glioblastoma following initial therapy

Principal Investigator(s)
David S. Baskin, MD, FACS, FAANS

Co-Investigator
Ivo Tremont, MD

Sponsor
Boston Biomedical Inc.

Summary
The purpose of this study is to compare DSP-7888 Dosing Emulsion plus Bev versus Bev alone in patients with recurrent or progressive GBM following treatment with first line therapy consisting of surgery and radiation with or without chemotherapy. Patients may have undergone a second surgery at the time of recurrence or progression, but may not have received any other anti-neoplastic therapy. Patients will be randomized 1:1 to treatment with DSP-7888 Dosing Emulsion plus Bev or Bev alone. This study includes the use of a novel molecule to kill recurrent glioblastomas. It has undergone interim analysis and the results are encouraging.  It will therefore continue to enroll patients.

METIS: Pivotal, open-label, randomized study of radiosurgery with or without Tumor Treating Fields [TTFields] for 1-10 brain metastases from non-small cell lung cancer [NSCLC].

Principal Investigator(s)
Ivo Tremont, MD

Co-Investigator
David S. Baskin, MD, FACS, FAANS

Sponsor 
Novocure Ltd.

Summary 
The purpose of this study is to test the efficacy, safety and neurocognitive outcomes of advanced NSCLC patients, following stereotactic radiosurgery (SRS) for 1 inoperable brain metastasis or 2-10 brain metastases, treated with NovoTTF-100M and supportive treatment compared to supportive treatment alone. Patients with brain metastases from NSCLC will be randomized to 1 of 2 treatment arms within 21 days of diagnosis:

HSV-tk + Valacyclovir + SBRT + Chemotherapy for Recurrent GBM

Principal Investigator(s)
David S. Baskin, MD, FACS, FAANS

Co-Investigator(s)
Ivo Tremont, MD
E. Brian Butler, MD, Radiation Oncology
Bin Teh, MD, Radiation Oncology

Sponsor
Kenneth R. Peak Brain & Pituitary Treatment Center at Houston Methodist Hospital

Summary
This is a prospective phase I-II study to assess the efficacy and toxicity of HSV-tk + valacyclovir gene therapy in combination with radiotherapy in recurrent glioblastoma multiforme or anaplastic astrocytoma. This study is comprised of patients who have failed standard of care treatment (maximal safe resection followed by chemoradiation).
Clinical response will be evaluated by neurological evaluation, neuropsychological testing, and imaging studies as well as by histological examination wherever a re-operation is clinically indicated. Blood samples will be taken for systemic immunological response, blood counts and liver functions tests.

 

A randomized controlled study to evaluate the efficacy and safety of fibrin sealant, vapour heated, solvent/detergent treated (FS VH S/D 500 s-apr) compared to DuraSeal Dural Sealant as an adjunct to sutured dural repair in cranial surgery

Principal Investigator(s) 
David S. Baskin, MD, FACS, FAANS

Co-Investigator(s)
Ivo Tremont, MD

Sponsor
Baxter Healthcare Corporation

Summary
The purpose of this study is to provide data on the safety and efficacy of FS VH S/D 500 s-apr compared to DuraSeal Dural Sealant as an adjunct to sutured dural closure in patients who are undergoing elective cranial surgery for the treatment of a pathological condition (eg, benign/malignant tumors, vascular malformations, or Chiari type 1 malformations) specifically in the PF or ST region. This study has recently been completed and new and novel tissue glue has been tested and found effective. More studies of this compound are underway.

HSV-tk and XRT and Chemotherapy for Newly Diagnosed GBM

Principal Investigator(s)
David S. Baskin, MD, FACS, FAANS

Co-Investigator(s)
Ivo Tremont, MD
E. Brian Butler, MD, Radiation Oncology
Bin Teh, MD, Radiation Oncology

Sponsor
Kenneth R. Peak Brain & Pituitary Treatment Center at Houston Methodist Hospital

Summary
This is a prospective, phase I-II study to assess the efficacy and toxicity of HSV-tk + valacyclovir gene therapy in combination with radiotherapy and standard of care chemotherapy for anaplastic astrocytoma (AA) or glioblastoma multiforme (GBM). This study is comprised of newly diagnosed patients with AA or GBM.

Clinical response will be evaluated by neurological evaluation, neuropsychological testing, and imaging studies as well as by histological examination. Blood samples will be taken for systemic immunological response, blood counts, and liver functions tests. Genetic testing of tumor tissue will be performed, including genetic analysis and cell cultures.

Patients receive a series of injections of the viral construct into the tumor bed during tumor resection.  They are then treated with the anti-viral drug Valacyclovir, and also receive standard of care treatment with radiation therapy and chemotherapy.  We have promising results with this trial.  



Mathew Futer had a similar treatment thirteen years ago using a much lower dose and he has no residual glioblastoma. 



Stratton Muhmel received this treatment and has gone on to graduate from Texas A&M Galveston with plans of starting a career and getting married.

CMV-specific Cytotoxic T Lymphocytes Expressing CAR Targeting HER2 in Patients With GBM (HERT-GBM)

Principal Investigator(s)
Nabil Ahmed, MD, MPH, Baylor College of Medicine

Co-Investigator(s)
David S Baskin, MD, FACS, FAANS

Sponsor
Baylor College of Medicine

Summary
This study is for patients that have a type of brain cancer called glioblastoma multiforme (GBM).

The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting cancer: antibodies and T cells. Antibodies are types of proteins that protect the body from infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. Both antibodies and T cells have been used to treat patients with cancers. They have shown promise, but have not been strong enough to cure most patients.

The antibody used in this study is called anti-HER2 (Human Epidermal Growth Factor Receptor 2). This antibody sticks to GBM cells because of a substance on the outside of these cells called HER2. Up to 80% of GBMs are positive for HER2. HER2 antibodies have been used to treat people with HER2-positive cancers. For this study, the HER2 antibody has been changed so that instead of floating free in the blood it is now attached to T cells. When an antibody is joined to a T cell in this way it is called a chimeric receptor. These chimeric receptor-T cells seem to be able to kill tumors like GBM, but they don't last very long and so their chances of fighting the cancer are limited. Therefore, developing ways to prolong the life of these T cells should help them fight cancer.

We found that T cells work better if we also attach a protein called CD28 to the HER2 chimeric receptor (HER2-CAR). In this study we placed this HER2-CAR into T cells that were pre-selected for their ability to recognize Cytomegalovirus (CMV). This virus exists in most people. These CMV-specific cytotoxic T cells (CMV-T cells) will be more active since they will react to the virus as well as to tumor cells. These HER2-CD28 CMV-T cells are an investigational product not approved by the Food and Drug Administration.

The purpose of this study is to find the largest safe dose of HER2-CD28 CMV-T cells, to learn what the side effects are, and to see whether this therapy might help patients with GBM.

 

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

Summary
This is a multicenter, randomized, open-label phase 2/3 study of Toca 511 and Toca FC versus standard of care that comprises Investigator's choice of single agent chemotherapy (lomustine or temozolomide) or bevacizumab administered to subjects undergoing resection for first or second recurrence (including this recurrence) of GBM or AA. Subjects meeting all of the inclusion and none of the exclusion criteria will be randomized prior to surgery in a 1:1 ratio to receive either Toca 511 and Toca FC (Experimental arm, Arm T) or control treatment with one option of standard of care (Arm SOC). Stratification will be done by IDH1 mutation status. A second stratification factor is based on the patient's Karnofsky Performance Score (KPS) (70-80 vs 90-100). Further, to account for potential differences in treatment choices for the control arm in regions, the trial will be stratified by geographical region during the randomization process.

Expanded Access Program Study Evaluating Oncomagnetic Therapy


Summary
This is an Expanded Access Program for Oncomagnetic therapy in combination with radiotherapy and standard of care chemotherapy in supratentorial Grade IV astrocytoma or glioblastoma (GBM). This study is comprised of a patient who failed initial standard of care treatment (maximal safe resection followed by chemoradiation) and whose tumors have recurred. The Patient was enrolled in a previous clinical trial.

Patients will be treated with Oscillating Magnetic fields generated by magnets mounted on a helmet.  In preclinical work, this is a powerful treatment that obliterates glioblastoma cells completely and is thought to be much more powerful than Optune, a commercially available treatment system that uses alternating electrical fields.  The first patient to receive this in the world is doing well.

A Pivotal Clinical Trail Evaluationg the Safety and Effectiveness of Adherus Autospray and Adherus Autospray ET Dural Sealant in Spinal Procedures


Summary
This is a prospective, randomized, controlled, single-blind, multicenter, pivotal trial that will evaluate the safety and effectiveness of Adherus Dural Sealant when used in conjunction with standard methods of dural repair in spinal procedures. This trial uses the commercially available DuraSeal Exact (P080013b) as an active control. The trial is designed to demonstrate non-inferiority of Adherus Dural Sealant to DuraSeal Exact. 

Subjects who have consented to participate in this study prior to undergoing spinal surgery and experience a durotomy, will be considered for study enrollment. Following a two-tiered inclusion/exclusion consideration, subjects will be randomized intraoperatively using a 1:1 randomization ratio. Up to 256 subjects will be enrolled and randomized to be treated with either Adherus Dural Sealant or DuraSeal Exact with a target of at least 50% of subjects undergoing a procedure at a lumbar or lumbosacral location. Up to 30 investigational sites within the United States will participate in this trial. 
 

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