The BRIDGES Clinical Trial (GTM-105) is a phase 3 clinical trial for people who have been newly diagnosed with a glioblastoma (GBM) brain tumor and need surgery. The purpose of this study is to find out if adding GammaTile® during surgical removal of a brain tumor improves survival outcomes compared to standard of care treatment. GammaTile is an FDA-cleared, implantable radiation therapy device placed directly in the surgical cavity at the time of tumor removal surgery. Each GammaTile is made of a 2 cm × 2 cm collagen square that contains four radioactive sources (about the size of a grain of rice). Once implanted, GammaTile begins delivering radiation immediately, right where the tumor was removed. Participants will be randomized into one of two groups (like flipping a coin), with 2 participants being randomized to receive GammaTile for every 1 participant receiving standard care. Participants randomized into the standard care arm will undergo tumor removal surgery followed by 6 weeks of external beam radiation therapy (EBRT) and oral chemotherapy (temozolomide, TMZ), followed by additional cycles of TMZ. Participants in the GammaTile arm will have the GammaTile placed into their surgical site, and also receive all the standard care treatments. However, the radiation course will be four weeks instead of six weeks, because GammaTile will deliver part of the radiation dose. Participants can expect to be enrolled in this trial for up to three years. The most common side effects from the procedures in this trial include radiation brain injury, surgical complications, infections and fatigue.
Both external radiation and GT are FDA cleared for the treatment of malignant (cancerous) brain tumors and available to patients. The experimental part of the study is comparing standard of care to standard of care plus GT for this type of brain tumor.
This study is to compare the usual treatment (radiation plus temozolomide alone) to using the study treatment (usual treatment plus the study drug, vorasidenib). The addition of the study drug, vorasidenib, to the usual treatment could shrink or stabilize your cancer. The study drug is FDA (Food and Drug Administration approved. The study drug will be given orally. The study will randomize (the computer will pick the group that the participant will be enrolled in) participant to Group 1 or Group 2. Participants can expect to be on the trial for 10 years or more. There will 4 participants enrolled locally.
Cancer caregivers in emerging and young adulthood (ages 18-35) are an underresearched and unsupported group of caregivers, and yet they are not uncommon. To address this critical support gap, the goal of this study is to develop and pilot test a caregiving support intervention specifically tailored for emerging and young adults caring for a parent with cancer. This phase of the study is intended to capture feedback on the intervention via focus groups with emerging and young adult caregivers of a parent with cancer.
This is a Phase 3 study. Phase 3 studies can involve testing a study drug in hundreds to thousands of people over several years. The main purpose of this study is to see if the study drug, Niraparib, works better than the comparator drug in people who have just been diagnosed with glioblastoma. The comparator drug is a type of chemotherapy commonly used to treat newly diagnosed glioblastoma.
This study includes:
• Phase 1, where subjects will take either the study drug or comparator drug. All participants will also receive radiotherapy in this phase. In this phase, there will be about 45 visits to the study center. The duration for this phase will last as long as the cancer does not get worse.
• Phase 2, where subjects will continue with the same drug given in Phase 1 without radiotherapy. In this phase there will be about 53 visits to the study center and participation in the study will last for 42 weeks.
There are four periods of the study, the screening period (last about 1 month), study treatment period (as long as desired or up to 8 months), safety follow-up period (1 month), and long-term follow up period (up to 5 years).
Some procedures in this study are blood tests, memory, speech and thinking test, ECG, tissue sample, bone marrow biopsy, and imaging test. Some risks include the cancer could get worse and there are risks associated with the study drugs (for example, low appetite, difficulty speaking, headaches, vomiting, nausea, diarrhea, etc.)
This study is for adult patients with large brain metastases. The purpose of this study is to compare two different radiation therapy dose treatments: staged stereotactic radiosurgery (SSRS) and fractionated stereotactic radiotherapy (FSRT). Both treatment options are currently used as standard of care. Participation in this study will include standard of care visits along with questionnaires completed for research purposes.
This study is for patients that have been diagnosed with relapsed/refractory neuroblastoma. The investigational drug given is eflornithine (DFMO) along with etoposide. DFMO is the investigational drug being used along with etoposide for treatment of neuroblastoma. Participants will undergo a number of standard tests and research-related procedures before being able to enroll in this study. Some risks include but are not limited to: fewer red and white blood cells, diarrhea, abdominal pain, loss of appetite, skin rash, seizure, difficulty swallowing and blurred vision. Participants can expect to be on this study for approximately 2 years. Participants will then be followed for up to 5 years after study completion.
This study is for newly diagnosed or previously untreated low-grade glioma (LGG). The overall goal of this study is to see if selumetinib works just as well as the standard treatment using carboplatin and vincristine (called CV) for subjects with LGG. Selumetinib is a drug that works by blocking a protein (a basic building block of the human body) that lets cancer cells grow without stopping. Participants can expect to receive treatment on this study for about 1–2 years. After study completion, participants will continue to be followed for up to 10 years.
This study is for participants that have been diagnosed with Medulloblastoma. The purpose of this study is to test the effectiveness of using an investigational agent called DFMO for Medulloblastoma. An investigational drug is one that has not been approved by the U.S. Food and Drug Administration (FDA). This study will look at the ability of this study drug to either keep participants tumor in remission or if they have active tumor, for their tumor to respond to the treatment and will also look at the safety and tolerability of DFMO. After this first day participants will be seen in clinic once every 30 days for the first 6 months of the study, after that they will be seen once every 90 days for the remainder of the study. These visits will last about 2 hours.
This study is for patients who have been diagnosed with a neuroblastoma (NBL). The purpose of this study is to find out if we can improve the treatment for subjects with high-risk NBL by adding the experimental drug 131I-MIBG or the experimental drug Crizotinib to recommended therapy. The secondary purpose is to find out if we can reduce the number of stem cell transplants from two to one if we give the experimental drug 131I-MIBG during Induction, and use different drugs as part of the transplant chemotherapy given prior to stem cell infusion during Consolidation. Participants can expect to be in this study for up to 2 years. Researchers would like to continue to follow participants health for up to 10 years.