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A Randomized Phase III Trial of Pre-Operative Compared to Post-Operative Stereotactic Radiosurgery in Patients with Resectable Brain Metastases

Principal Investigator:

Tony J. Wang, MD, FASTRO

Contact Number:

212-342-5162

NCT Number:

NCT05438212

Population:

Adult

Phase:

III

The purpose of this study is to compare the usual treatment of having SRS after surgery to receiving SRS before surgery (the study approach). Receiving SRS before surgery could increase the time without your cancer returning or worsening. If you decide to take part in this study, you will be assigned to one of two groups. Half the participants will be assigned to one group and half to a second group. Participants in both groups will get a type of radiation called stereotactic radiosurgery (SRS). SRS delivers a high dose of radiation only to the small areas of cancer in the brain and avoids...
A PHASE 1A/B OPEN-LABEL MASTER STUDY OF PF-07799544 AS ASINGLE-AGENT AND IN COMBINATION WITH OTHER TARGETED AGENTSIN PARTICIPANTS WITH ADVANCED SOLID TUMORS

Principal Investigator:

Aya Haggiagi, MD

Contact Number:

212-342-5162

NCT Number:

NCT05538130

Population:

Adult

Phase:

I

The purpose of this study is to learn about the safety (the impact of the study drug on your body) and the effects of study drug PF-07799544 for specific types of cancer on the body and to find the best dose for treating certain cancers. For BRAF (B-raf proto-oncogene serine/threonine kinase) mutated solid tumors, PF-07799544 may be combined with encorafenib, also known as BRAFTOVI® (an FDA approved cancer medication). The study drug PF-07799544 is an investigational drug because it is not FDA approved for use in this country. The study drug encorafenib is approved in this country and is...
ONC201 for the Treatment of Newly Diagnosed H3 K27M-mutant Diffuse Glioma Following Completion of Radiotherapy: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study

Principal Investigator:

Aya Haggiagi, MD

Contact Number:

212-342-5162

NCT Number:

NCT05580562

Population:

Adult

Phase:

III

The purpose of this study is to see if ONC201 is effective in treating participants with glioma when given following radiation therapy, how safe and tolerable ONC201 as compared to using placebo (a capsule that looks like ONC201 but does not contain any active drug), and to see how well ONC201 can improve quality of life and brain functioning in patients with glioma. ONC201 is a new drug that is being developed for treating people with glioma. ONC201 may help to remove tumor cells without affecting normal cells of the body. ONC201 is a first-in-class drug, which means it is a new drug having...
A Three-part, Phase I/II Dose-Escalation Study to Define the Safety, Tolerability, and Optimal Dose of Candidate GBM vaccine VBI-1901 with Subsequent Extension of Optimal Dose in Recurrent GBM subjects.

Principal Investigator:

Andrew B. Lassman, MD

Contact Number:

212-342-5162

NCT Number:

NCT03382977

Population:

Adult

Phase:

I/II

The purpose of this study is to test the safety of a new vaccine, VBI-1901, and to know more about it's ability to boost the response of the immune system against Cytomegalovirus. The reason for testing this vaccine in people with a brain tumor is that it might one day be used to boost the ability of the immune system to fight a certain type of brain tumor. This type of treatment for brain tumors is called immunotherapy. Are you Eligible? (Inclusion Criteria) Participants must: 1. Be 18 - 70 years of age 2. Have histologically confirmed WHO grade IV glioblastoma 3. Have unequivocal evidence...
A randomized, open-label, multicentric, two-arm pivotal trial of SonoCoud-9 combined with carboplatin (CBDCA) vs standard of care lomustine (CCNU) or temozolomide (TMZ) in patients undergoing planned resection for first recurrence glioblastoma

Principal Investigator:

Brian John Andrew Gill, MD

Contact Number:

212-342-5162

NCT Number:

NCT05902169

Population:

Adult

Phase:

III

The purpose of this study is to see if the implantable device, Sonocloud 9, is effective getting chemotherapy to better reach your tumor compared to receiving standard of care chemotherapy [Temozolomide and Lomustine] and to see how safe and tolerable the device is. Sonocloud 9 works by making the blood-brain barrier (BBB) more permeable(allowing liquids or gases to go through it) so chemotherapy can better reach your tumor. The BBB is a natural sealing of the blood vessels in the brain. This study is being done in participants whose brain tumor has returned and are eligible for surgery to...
CHRONIC CONVECTION ENHANCED DELIVERY OF TOPOTECAN FOR RECURRENT MALIGNANT GLIOMA

Principal Investigator:

Jeffrey N Bruce, MD

Contact Number:

212-342-5162

Population:

Adult

Phase:

I

The purpose of this study is to determine the safety of directly injecting a chemotherapy drug called Topotecan and a contrast agent called Gadolinium into malignant brain tumors. Currently there is no effective treatment for recurrent malignant brain tumors, which means the brain tumor has returned after the original tumor has been treated. Most systemic chemotherapy drugs have toxic side effects, which make them difficult to use for brain tumors. However, we are doing this study to find out if using an experimental method of directly infusing the drug into the tumor, allows research...
A Feasibility Study Examining the Use of Non-Invasive Focused Ultrasound (FUS) with oral Etoposide Administration in Children, Adolescents, and Young Adults with Progressive Diffuse Midline Glioma (DMG)

Principal Investigator:

James Hinkley Garvin Jr, MD

Contact Number:

212-342-5162

NCT Number:

NCT05762419

Population:

Pediatrics/Adult

Phase:

I

Children and young adults with diffuse midline glioma will be treated with Focused Ultrasound (FUS) with DEFINITY® microbubbles and neuro-navigator-controlled sonication. The overall goal of this study is to see if the study treatment plan will improve the outcome of participants with diffuse midline glioma, for which no known cure exists, and determine whether there are any clinical benefits of the study treatment. Children with progressive diffuse midline gliomas (DMGs) have very poor outcomes and have very limited options. One of the main obstacles in the effectiveness of medical...
A Phase 2 Study of Erdafitinib in Patients with Recurrent or Progressive IDH-Wild Type Glioma with an FGFR-TACC Gene Fusion

Principal Investigator:

Aya Haggiagi, MD

Contact Number:

212-342-5162

NCT Number:

NCT05859334

Population:

Adult

Phase:

II

This study is being done to answer the following question: Will erdafitinib treatment be able to shrink or slow the growth of brain cancer that has returned or gotten worse after treatment? This study is being done to find out if treatment with erdafitinib is better or worse than the usual approach for your brain cancer. The usual approach is defined as care most people get for brain cancer: treatment with surgery, radiation, or FDA-approved drugs such as lomustine or bevacizumab. Sometimes, combinations of these treatments are used. Are you Eligible? (Inclusion Criteria) Are you 18 years of...
A Phase III Trial of Lomustine-Temozolomide Combination Therapy Versus Standard Temozolomide in Patients with Methylated MGMT Promoter Glioblastoma

Principal Investigator:

Fabio M. Iwamoto, MD

Contact Number:

212-342-5162

NCT Number:

NCT05095376

Population:

Adult

Phase:

III

The purpose of this study is to compare the usual radiation therapy and usual chemotherapy, temozolomide, to using the usual radiation therapy and usual chemotherapy plus the chemotherapy drug lomustine (Gleostine). Lomustine (Gleostine) is already approved by the FDA for use in brain tumors but it is usually used alone and is not the first-line choice for methylated MGMT tumors. Adding a second chemotherapy drug, lomustine (Gleostine), to usual chemotherapy and radiation therapy could extend your life or shrink or stabilize your cancer. But, it could also cause side effects, which the study...
A Phase I/II Study of Nivolumab Plus or Minus Ipilimumab in Combination with Multi-Fraction Stereotactic Radiosurgery for Recurrent High-Grade Radiation-Relapsed Meningioma

Principal Investigator:

Aya Haggiagi, MD

Contact Number:

212-342-5162

NCT Number:

NCT03604978

Population:

Adult

Phase:

I/II

Phase 2, Treatment A: This study is being done to see if your recurrent brain tumor may respond to a combination of radiosurgery (a type of radiation therapy) with nivolumab (a type of immunotherapy drug). A small number of patients have already received this combination previously and have tolerated the treatment relatively well. However, we would like to see if the combination treatment may be better or worse than the standard approach of radiosurgery alone. We would also want to learn more about the side effects associated with giving nivolumab with radiosurgery. Phase 2, Treatment B: This...

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