Primary Brain and Spinal Cord Tumors Clinical Trials

12 trials identified.

PERFORMANCE for Glioblastoma
Principal Investigator: Ashley, David
Protocol Number: PRO00034208

Age Group: Adult
Scope: Local

Phase: I (Cancer Control)
Disease Site: Brain and Nervous System

Contact: DCI Clinical Research Team, Tisch Brain Tumor Center
Email:

What is the Condition Being Studied?
Newly diagnosed glioblastoma (brain cancer)
What is the Purpose of this Study?
We are doing this study to see if the study vaccine is safe for patients who are newly diagnosed with glioblastoma and to see which type of temozolomide schedule works best with the study vaccine.  
Who Can Participate in the Study?
Adults newly diagnosed with a type of brain cancer called glioblastoma who:
- Have had a complete or partial surgery for their brain cancer
- Are positive for antibodies to CMV
- Are on a stable or decreasing dose of steroids
What is Involved?
If you choose to be in this study, you will: 
- Have your blood tested for antibodies (substances produced by the body to fight infections) to a common virus called cytomegalovirus (CMV)
- Complete standard radiation and chemotherapy
- Be randomized (like the flip of a coin) to receive either: 
-- Group 1:  Standard additional treatment with temozolomide for 5 days of every month for 6-12 months
-- Group 2:  Temozolomide for 21 days of every month 
- Receive study vaccines every 2 weeks for the first 3 vaccines and then monthly.  Study vaccines are given by injections (shots) in the leg  
Participating Institutions:
  • Duke University Health System : Tisch Brain Tumor Center DCI Clinical Research Team
View this trial at ClinicalTrials.gov

D2C7 for Adult Patients with Recurrent Malignant Glioma
Principal Investigator: Randazzo, Dina
Protocol Number: PRO00053325

Age Group: Adult
Scope: Local

Phase: I (Cancer Control)
Disease Site: Brain and Nervous System

Contact: DCI Clinical Research Team, Tisch Brain Tumor Center
Email:

What is the Condition Being Studied?
Grade III or IV malignant glioma (brain tumor) that has progressed or recurred
What is the Purpose of this Study?
We are doing this study to learn how much drug (D2C7-immunotoxin) can be safely given to people with malignant gliomas that have progressed or recurred
Who Can Participate in the Study?
Adult men and women who:
- Are diagnosed with recurrent WHO Grade III or IV malignant glioma  
- Are able to have an MRI (magnetic resonance imaging) 
- Do not have an allergy to gadolinium contrast agents  
- Are not in active treatment for other, unrelated types of cancer, except for cervical cancer or squamous cell cancer.

Please contact the study team for more detailed information.
What is Involved?
If you agree to take part in this study, you will:  
- Have a brain biopsy to determine the type of recurrent tumor you have  
- Stay in the hospital and have a catheter inserted into the tumor location  
- Receive an investigational drug (D2C7-immunotoxin) delivered directly into your brain tumor
- Have several tests and procedures including medical history, physical exam, and blood tests  
- Have post-infusion clinic visits
Participating Institutions:
  • Duke University Health System : Tisch Brain Tumor Center DCI Clinical Research Team
View this trial at ClinicalTrials.gov

BMX-001 for Glioma
Principal Investigator: Peters, Katherine
Protocol Number: PRO00062660

Age Group: Adult
Scope: Local

Phase: I/II (Cancer Control)
Disease Site: Brain and Nervous System

Contact: DCI Clinical Research Team, Tisch Brain Tumor Center
Email:

What is the Condition Being Studied?
Newly diagnosed High Grade Glioma Brain Cancer (Grade III or Grade IV) 
What is the Purpose of this Study?
We are doing this study to test the effect (good or bad) of the study drug BMX-001 when given with radiation therapy and temozolomide.  

We also want to look at the effect (good or bad) of BMX-001 in how it protects your brain from the worsening of cognitive (thinking) abilities and quality of life that is sometimes experienced when undergoing treatment with radiation therapy and temozolomide for high grade glioma.
Who Can Participate in the Study?
Adults who:
- Have been diagnosed with Grade III or Grade IV Glioma brain cancer
- Are within 12 weeks of the surgery for their brain cancer
- Have not had radiation for any brain cancer
What is Involved?
This study is now in the phase II portion of the study. 

If you join the study, you will:
- Be randomized (Like a flip of a coin) to get either:
-- Arm A: The study drug BMX-001 injected under the skin with standard of care treatment (six weeks of daily radiation therapy and oral chemotherapy [temozolomide])
---The first dose of BMX-001 is given a couple of days before radiation therapy starts, and then you will get 2 injections a week for 8 weeks. 

OR

-- Arm B: Standard of care treatment (six weeks of daily radiation therapy and oral chemotherapy [temozolomide])

- Give information on your quality of life, side effects of the treatment, survival and neurocognitive (your ability to think) effects before and after temozolomide and radiation therapy is given
Participating Institutions:
  • Duke University Health System : Tisch Brain Tumor Center DCI Clinical Research Team
View this trial at ClinicalTrials.gov

Phase 1B: PVSRIPO in Children with Glioma
Principal Investigator: Thompson, Eric
Protocol Number: PRO00071228

Age Group: Children
Scope: Local

Phase: I (Cancer Control)
Disease Site: Brain and Nervous System

Contact: DCI Clinical Research Team, Tisch Brain Tumor Center
Email:

What is the Condition Being Studied?
Brain Cancer (World Health Organization [WHO] Grade III or IV)
What is the Purpose of this Study?
We are doing this study to make sure that the dose of PVSRIPO we have chosen is safe to give to children and young adults and to see if PVSRIPO will work against Grade III and IV brain cancer.
Who Can Participate in the Study?
Children 12 to 18 years old or adults 19 to 21 years old who have been diagnosed with brain cancer (WHO Grade III or IV) that has progressed or recurred.
What is Involved?
If you or your child choose to join this study, you or your child will:
- Get a polio immunization booster shot 
- Have a blood test to make sure your body is protected against polio, both before and after the booster shot
- Be admitted to the hospital for a surgical biopsy of the tumor the following morning
-- If the biopsy is positive for Grade III or IV brain cancer, a catheter will be placed in the location of the biopsy
- Get an infusion of PVSRIPO, which is s form of the live polio virus vaccine that has been changed by removing a piece of the virus and replacing it with a piece from a common cold virus
-- The infusion is given through the catheter and takes about 6 and a half hours.  The catheter is then removed
- Be watched overnight in the hospital
- Be followed in the clinic by the study team for at least 1 year
Participating Institutions:
  • Duke University Health System : Tisch Brain Tumor Center DCI Clinical Research Team
View this trial at ClinicalTrials.gov

Phase II Rolapitant-Varubi (Newly diagnosed Glioma)
Principal Investigator: Affronti, Mary
Protocol Number: PRO00076418

Age Group: Adult
Scope: Local

Phase: II
Disease Site: Brain and Nervous System

Contact: Maxey, Cheryl
Phone:

What is the Condition Being Studied?
Newly diagnosed with Malignant Glioma Brain Cancer  
What is the Purpose of this Study?
We are doing this study to look at how well Rolapitant and Ondansetron works to help control nausea and vomiting in malignant glioma patients receving radiation therapy and chemotherapy (temozolomide).
Who Can Participate in the Study?
Adults who:
- Are diagnosed with malignant glioma (brain cancer) 
- Are scheduled to get radiation therapy in combination with chemotherapy (temozolomide)
- Are not currently taking a medication to help prevent nausea and vomiting
What is Involved?
If you join this study, you will:
- Be randomized (put into one of two groups by chance like a flip of a coin) to get:
-- Group A: Ondansetron daily for 6 weeks with 1 dose of Rolapitant on day 22 
-- Group B: Ondansetron daily for 6 weeks with 1 dose of Rolapitant on day 1
- Be asked to complete questionnaires, keep a medication log and track any nausea and vomiting that you may have while you are on the study
- Be in this study for the 6 weeks of radiation and will have one follow-up contact 2 weeks after you finish the study
Participating Institutions:
  • Duke University Health System : Tisch Brain Tumor Center DCI Clinical Research Team, Cheryl Maxey, William Morrissey
View this trial at ClinicalTrials.gov

Phase 3 Study for Eflornithine and Lomustine in Brain Cancer Patients
Principal Investigator: Desjardins, Annick
Protocol Number: PRO00076758

Age Group: Adult
Scope: National

Phase: III (Cancer Control)
Disease Site: Brain and Nervous System

Contact: DCI Clinical Research Team, Tisch Brain Tumor Center
Email:

What is the Condition Being Studied?
Brain Cancer (WHO [World Health Organization] Grade 3 Anaplastic Astrocytoma)
What is the Purpose of this Study?
We are doing this study to find out if eflornithine is safe and will work when it is taken with lomustine when compared to taking lomustine alone for patients diagnosed with anaplastic astrocytoma.
Who Can Participate in the Study?
Adults who have been diagnosed with WHO Grade 3 anaplastic astrocytoma that progressed or recurred for the first time after standard radiation and chemotherapy
What is Involved?
If you choose to be in this study, you will: 

- Be randomly (like a flip of a coin) assigned to one of two groups:
 
-- Group A will get eflornithine and lomustine
--- Complete a 6-week cycle and will repeat this cycle for a total of 2 years
--- Come to the clinic about every 3 months during the 2nd year

and

-- Group B will get lomustine only
--- Lomustine will be taken once every 6 weeks for up to 1 year
-- Come to the clinic about every 6 weeks for 6 months and then about every 10 weeks thereafter during the 1st year

Participating Institutions:
  • Duke University Health System : Tisch Brain Tumor Center DCI Clinical Research Team
View this trial at ClinicalTrials.gov

Multicenter Ph.2 PVSRIPO
Principal Investigator: Ashley, David
Protocol Number: PRO00077024

Age Group: Adult
Scope: Local

Phase: II (Cancer Control)
Disease Site: Brain and Nervous System

Contact: DCI Clinical Research Team, Tisch Brain Tumor Center
Email:

What is the Condition Being Studied?
Brain Cancer (WHO [World Health Organization] Grade 4 Glioma)
What is the Purpose of this Study?
We are doing this study to look at if PVSRIPO is safe and will work for patients diagnosed with Grade 4 glioma that has recurred or progressed.
Who Can Participate in the Study?
Adults who:
- Have been diagnosed with WHO Grade 4 glioma that progressed or recurred for the first or second time 
- Have a tumor that meets size and location in brain requirements
- Are not pregnant or breastfeeding
What is Involved?
If you choose to be in this study, you will: 
- Get a polio immunization booster shot 
- Have a blood test to make sure your body is protected against polio, both before and after the booster shot
- Be admitted to the hospital for a surgical biopsy of the tumor.
-- If the biopsy is positive for Grade 4 glioma, a catheter will be placed in the location of the biopsy.
- Get an infusion of PVSRIPO, which is a form of the live polio virus vaccine that has been changed by removing a piece of the virus and replacing it with a piece from a common cold virus.  
-- The infusion is given through the catheter and takes about 6 and a half hours.  The catheter is then removed.
- Be observed for at least a night in the hospital
- Are followed in the clinic by the study team for at least 1 year
Participating Institutions:
  • Duke University Health System : Tisch Brain Tumor Center DCI Clinical Research Team
View this trial at ClinicalTrials.gov

The PRiME Study for Brain Cancer
Principal Investigator: Thompson, Eric
Protocol Number: PRO00079843

Age Group: Children
Scope: Local

Phase: I (Cancer Control)
Disease Site: Brain and Nervous System

Contact: DCI Clinical Research Team, Tisch Brain Tumor Center
Email:

What is the Condition Being Studied?
Brain Cancer (World Health Organization [WHO] Grade III or IV glioma or medulloblastoma)
What is the Purpose of this Study?
We are doing this study see if the PEP-CMV vaccine can help the immune system fight brain cancer.
Who Can Participate in the Study?
Children aged 3 to 17 years old with:
- WHO Grade III or IV glioma that has progressed or recurred.
- Medulloblastoma that has progressed or recurred

and

Adults aged 18 to 35 years old with:
- Medulloblastoma that has progressed or recurred
What is Involved?
If you or your child choose to join this study, you or your child will: 
- Have your blood tested for antibodies (substances produced by the body to fight infections) to a common virus called cytomegalovirus (CMV) 
- Have standard radiation therapy with temozolomide chemotherapy before beginning study procedures
- Have blood drawn that is routine and blood drawn for research that will look at your immune system
- Get a Tetanus-diphtheria (Td) immunization shot before beginning study vaccines (given as a shot in the leg)
- Get PEP-CMV study vaccines every 2 weeks for the 1st 3 vaccines and then monthly thereafter
Participating Institutions:
  • Duke University Health System : Tisch Brain Tumor Center DCI Clinical Research Team
View this trial at ClinicalTrials.gov

ECOG-ACRIN EAF151 for Glioblastoma
Principal Investigator: Crawford, Jeffrey
Protocol Number: PRO00084094

Age Group: Adult
Scope: National

Phase: N/A
Disease Site: Other

Contact: DCI Clinical Research Team, Tisch Brain Tumor Center
Email:

What is the Condition Being Studied?
Brain cancer (glioblastoma or gliosarcoma)
What is the Purpose of this Study?
We are doing this study to test whether the advanced perfusion MRI done prior to starting bevacizumab and a few weeks after starting bevacizumab can determine your response to the treatment better than the standard MRI performed at typical time points. The researchers want to see if this type of advanced MRI is better or the same as what is usually used for monitoring your brain cancer.

Bevacizumab is considered standard of care, meaning it is the normal approach to treating this kind of cancer. 
Who Can Participate in the Study?
Adults over 18 years of age who
- Have histologically proven intracranial glioblastoma or gliosarcoma at initial surgery
- Have progression of disease assessed by local site using RANO criteria
- Are not pregnant or breast-feeding
What is Involved?
If you agree to be in this study:
All research study participants will be treated for recurrent brain cancer with bevacizumab and will have two advanced perfusion MRI scans. 
-- The first advanced MRI will be done just before your treatment starts with bevacizumab, 
-- The second advanced MRI will be done between 12 and 25 days after you start your treatment with bevacizumab, within three days prior to your second dose. 
Participating Institutions:
  • Duke University Health System : Tisch Brain Tumor Center DCI Clinical Research Team
View this trial at ClinicalTrials.gov

ATTAC-II for Glioblastoma
Principal Investigator: Peters, Katherine
Protocol Number: PRO00084478

Age Group: Adult
Scope: National

Phase: II (Cancer Control)
Disease Site: Brain and Nervous System

Contact: DCI Clinical Research Team, Tisch Brain Tumor Center
Email:

What is the Condition Being Studied?
Brain Cancer (newly diagnosed glioma)
What is the Purpose of this Study?
We are doing this study to learn if the study vaccine is effective against a type of brain cancer called glioblastoma when it is given with stronger doses of normal chemotherapy.
Who Can Participate in the Study?
Adults 18 years old or older who have been newly diagnosed with glioblastoma.
What is Involved?
If you agree to be in this study: 
-You will be randomly (like drawing numbers from a hat) assigned to one of three groups.   
--Group 1 will receive the short preparation of the pp65 DC vaccine,
--Group 2 will receive the long preparation of the pp65 DC vaccine,
--Group 3 will receive a placebo that will look like and be given in the same way as the pp65 DC vaccine

- You will undergo a leukapheresis procedure in which blood is collected into a machine that removes white blood cells and then returns the remainder of the blood back to you.  The white blood cells removed from the blood are used to make a study vaccine.  

- After the leukapheresis, you will have standard treatment for your brain cancer (radiation therapy and chemotherapy) before you get the study vaccines.  Vaccines are given as a shot in the leg.
Participating Institutions:
  • Duke University Health System : Tisch Brain Tumor Center DCI Clinical Research Team
View this trial at ClinicalTrials.gov

LGG-14C03 for Low Grade Glioma
Principal Investigator: Ashley, David
Protocol Number: PRO00088729

Age Group: Both
Scope: National

Phase: III
Disease Site: Other

Contact: DCI Clinical Research Team, Tisch Brain Tumor Center
Email:

What is the Condition Being Studied?
Brain cancer (low grade glioma)
What is the Purpose of this Study?
We are doing this study to learn and understand if the chemotherapy drug called carboplatin works as well as the standard therapy. The standard therapy for low grade glioma in children and young adults is using a combination of carboplatin and vincristine.  

This study will try to understand if treatment with carboplatin alone improves quality of life for patients with low grade glioma and their families.
Who Can Participate in the Study?
Patients who:
- Are less than 21 years old
- Are newly or previously diagnosed with a low grade brain tumor, such as glioma
What is Involved?
If you choose to join this study, you will:
-Be randomly assigned (like the flip of a coin) to get one of two treatments: 
-- A combination of the chemotherapy drugs carboplatin and vincristine
-- The chemotherapy drug carboplatin by itself
View this trial at ClinicalTrials.gov

UM1 10186 Nivo +/- Ipi with SRS in Meningioma
Principal Investigator: Abbruzzese, James
Protocol Number: PRO00101451

Age Group: Adult
Scope:

Phase: I/II
Disease Site: Brain and Nervous System

Contact: DCI Clinical Research Team, Tisch Brain Tumor Center
Email:

What is the Condition Being Studied?
Meningioma
What is the Purpose of this Study?
We are doing this study to see if it is safe to combine nivolumab with or without ipilimumab (two different types of immunotherapy drugs) with radiosurgery (a type of radiation therapy) for your type of recurrent brain tumor.  We are looking at the side effects of giving patients nivolumab (with or without ipilimumab) along with radiosurgery.

Who Can Participate in the Study?
Adults with meningioma that have been previously treated with radiation. 
What is Involved?
If you choose to join this study, you will:
- Get either the study drug nivolumab for up to 12 months along with a type of radiation therapy called stereotactic radiosurgery at the beginning of the study (3 radiation treatments)
OR 
- Get nivolumab and stereotactic radiosurgery plus another study drug, ipilimumab 

- Have routine MRI and blood tests
- Have thyroid testing done every 8 weeks
Participating Institutions:
  • Duke Cancer Center Cary : Tisch Brain Tumor Center DCI Clinical Research Team
  • Duke Center for Living/Sarah Stedman Nutrition : Tisch Brain Tumor Center DCI Clinical Research Team
  • Duke Primary Care : Tisch Brain Tumor Center DCI Clinical Research Team
  • Duke Private Diagnostic Clinic (PDC) : Tisch Brain Tumor Center DCI Clinical Research Team
  • Duke Raleigh Hospital : Tisch Brain Tumor Center DCI Clinical Research Team
  • Duke Regional Hospital : Tisch Brain Tumor Center DCI Clinical Research Team
  • Duke University Health System : Tisch Brain Tumor Center DCI Clinical Research Team
  • Duke Women's Cancer Care Raleigh (Macon Pond) : Tisch Brain Tumor Center DCI Clinical Research Team
  • Johnston Health (Smithfield) : Tisch Brain Tumor Center DCI Clinical Research Team
  • Maria Parham Health (Henderson) : Tisch Brain Tumor Center DCI Clinical Research Team
  • Scotland Health Care System (Laurinburg) : Tisch Brain Tumor Center DCI Clinical Research Team
  • Southeastern Regional Medical Center (Lumberton) : Tisch Brain Tumor Center DCI Clinical Research Team
View this trial at ClinicalTrials.gov