675 Clinical Trials for Various Conditions
This trial aims at investigating the diagnostic ability of a combined diagnostic panel including systematic endoscopic evaluation (SEE), blood-based ctDNA assay, and urine-based cfDNA assay to predict the presence of residual tumor remaining in the bladder at cystectomy. Patients who are planned for cystectomy due to bladder cancer will be considered for enrollment based on inclusion and exclusion criteria.
RATIONALE: Photodynamic therapy uses a drug, such as HPPH, that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. This may be an effective treatment for laryngeal cancer. PURPOSE: This phase I trial is studying the side effects and best dose of laser light therapy when given together with HPPH in treating patients with dysplasia, cancer in situ, or invasive cancer of the larynx.
This trial studies how well dynamic susceptibility contrast-magnetic resonance imaging (MRI) works in determining radiation necrosis and tumor progression in participants with cancer that has spread to the brain and are being treated with radiation therapy. Diagnostic procedures, such as dynamic susceptibility contrast-MRI, may improve the ability to determine indeterminate post-treatment changes seen on imaging after radiation therapy.
Phase 2, open-label study of AVB-620 in women with primary, nonrecurrent and nonmetastatic breast cancer undergoing surgery.
This trial studies how well an interactive survivorship program works in improving healthcare resources in adolescent and young adult cancer survivors. By improving access to survivorship resources, health literacy, self-management skills, and support, an interactive survivorship program may help to improve adherence to adolescent and young adult healthcare guidelines and reduce cancer-related distress.
In this study we will collect granular information on cancer patients infected with COVID-19, as rapidly as possible. The mechanism for collection of this information is a de-identified centralized registry housed at Vanderbilt University Medical Center, with data donations from internal and external health care professionals.
Balancing Method for Pain Related to Advanced Cancer seeks to confirm the benefit of acupuncture for patients with pain related to advanced cancer.
This research study involves pre-operative therapy that is specifically targeted for breast cancer in individuals with BRCA and PALB2 mutations. The names of the study drugs involved in this study are: * Niraparib (Zejula) * Dostarlimab
This study is a phase I, single arm, open-label trial of PD0332991 in combination with Paclitaxel in patients with Rb-expressing metastatic breast cancer. Up to 20 patients are anticipated to be enrolled to reach the Maximum Tolerated Dose (MTD) of PD0332991 in combination with Paclitaxel. Once the MTD is established, an additional expanded cohort of 10 patients will be enrolled at that dose to establish the Recommended Phase 2 Dose (RP2D), obtain additional safety data and perform exploratory biomarker studies.
The goal of this part (Part 1) of this clinical research study is to learn about the safety of giving 2 doses of SCH 72105 (also known as rAd-IFN) directly into the bladder to patients with bladder cancer that has come back. The goal of Part 2 of this study is to learn about the safety of giving 2 more doses of SCH 72105 directly into the bladder of Part 1 participants who had no sign of bladder cancer after Week 12. The level of effectiveness of SCH 72105 will also be studied by measuring the interferon (IFN) levels in the urine.
Phase 2 Study of TYRA-300 in FGFR3 Altered Low Grade, Intermediate Risk NMIBC
The purpose of this study is to compare the effectiveness of different FDA-approved/NCCN-recommended drug treatments for NMIBC. In particular, the FDA-approved drug nadofaragene firadenovec will be compared to usual care with other NCCN-recommended standard treatments for NMIBC (gemcitabine with or without docetaxel, mitomycin, re-treatment with BCG, or pembrolizumab).
This expanded access protocol is designed to provide Recombinant Mycobacterium BCG (rMBCG) to patients with Non-muscle invasive bladder cancer (NMIBC) who are eligible to receive TICE® BCG, may benefit from its use, and who are ineligible to participate in a clinical trial using rMBCG, or for other reasons cannot participate (eg, geographically unable to access a study site).
Patients with MIBC will receive 3 cycles (C1-C3) of induction enfortumab vedotin plus pembrolizumab followed by restaging including MRI of the bladder, urine cytology, and cystoscopy with TURBT of any visible tumor and/or resection site plus random biopsies using a recommended template. Patients achieving a stringently defined cCR (clinical complete response) will receive 14 cycles of "maintenance" treatment. Enfortumab vedotin will be administered during the first 6 cycles (C4-C9) of "maintenance" treatment and pembrolizumab will be given all 14 cycles (C4-C14). Patients with any residual disease at clinical restaging (i.e., \>cTa disease) will undergo cystectomy.
This phase II trial is being done to develop and test a healthy eating program to reduce cancer recurrence (cancer that has come back after a period of improvement) and/or progression (cancer that is growing, spreading, or getting worse) in patients with non-muscle invasive bladder cancer (NMIBC). Researchers want to better understand how incorporating more cruciferous vegetables in the diet may reduce the risk of cancer recurrence or progression in men and women who were diagnosed with early-stage bladder cancer and compare whether extending the program can further improve bladder cancer outcomes. POW-R Health is a behavioral dietary intervention designed to modestly increase cruciferous vegetable (cruciferae) intake in patients. Cruciferous vegetables, such as cabbage, kale and broccoli, arugula, contain phytochemicals known as isothiocyanates (ITCs). Dietary ITCs exert potent anticancer activities against bladder cancer and can be rapidly metabolized, delivered to the bladder, and concentrated in the urine. Participating in the healthy eating program may reduce bladder cancer recurrence or progression in NMIBC survivors.
This is a research study to evaluate the effectiveness of 3 different types of routine pain management regimens used during clinically indicated, minimally invasive oncologic (cancer) surgery. This project is considered "Research" and participation is voluntary. Upon enrollment in this study, the research team will collect data from the patient's medical records. The patient will undergo all of the normal testing and procedures required pre-operatively (standard of care). The study team will then randomly assign the patient (like a flip of a coin) to one of three different study arms for pain management during surgery: 1. Laparoscopic Transversus Abdominis Plane Block (LapTAP) with Local Anesthetic (LA) 2. Laparoscopic Transversus Abdominis Plane Block (LapTAP) only 3. Local Anesthetic (LA) only The patient will receive standard pre- and post-operative care according to clinical guidelines (routine care). The study team will collect information from the patient's medical record for the first 24 hours after their surgery and upon discharge. This information will include pain scores, amount of medication required, any side effects the patient may have experienced, and satisfaction with pain control. Participation in the study will end upon discharge from the hospital.
This phase III trial compares the effect of low dose tamoxifen to usual hormonal therapy, including aromatase inhibitors, in treating post-menopausal women with hormone positive, HER2 negative early stage breast cancer. Tamoxifen is in a class of medications known as antiestrogens. It blocks the activity of estrogen (a female hormone) in the breast. This may stop the growth of some breast tumors that need estrogen to grow. Aromatase inhibitors, such as anastrozole, letrozole, and exemestane, prevent the formation of estradiol, a female hormone, by interfering with an aromatase enzyme. Aromatase inhibitors are used as a type of hormone therapy to treat postmenopausal women with hormone-dependent breast cancer. Giving low dose tamoxifen may be more effective compared to usual hormone therapy in treating post-menopausal women with hormone-positive, HER2 negative early stage breast cancer.
The goal of this clinical trial is to learn if gemcitabine/cisplatin plus cemiplimab with or without fianlimab works to treat bladder cancer in adults. The main question it aims to answer is: Can gemcitabine, cisplatin, and cemiplimab with or without fianlimab treat bladder cancer? Participants will be randomly selected (like the loss of a coin) to treatment with gemcitabine, cisplatin, cemiplimab, and fianlimab or gemcitabine, cisplatin, and cemiplimab. Participants will: * Undergo transurethral resection of bladder tumor (TURBT) followed by the start of treatment, receive 4 cycles of treatment (21 day cycles) * After 4 cycles of treatment, patients will undergo repeat maximal TURBT with imaging * Participants with a complete response will continue maintenance cemiplimab or cemiplimab/fianlimab for 13 more cycles with imaging every 3 months * Participants without a complete clinical response will undergo cystectomy (bladder surgery).
The pivotal phase 3 trial (rAd-IFN-CS 003) evaluating the efficacy of nadofaragene firadenovec showed that 55 (53.4%) of 103 subjects with CIS ± high-grade Ta/T1 achieved a complete response (CR) at 3 months. In this trial, the safety and efficacy of intravesical instillation of nadofaragene firadenovec alone or in combination with chemotherapy or immunotherapy will be evaluated in participants with NMIBC CIS (± high-grade Ta/T1).
Comparing white-light cystoscopy (WLC) and blue-light cystoscopy (BLC) in TURBT for high risk (HR) non-muscle invasive bladder cancer (NMIBC) patients is crucial to determine the most effective method for reducing residual disease burden and improving recurrence-free survival. Enhanced visualization with BLC may lead to more accurate resections, potentially decreasing recurrence rates and improving long-term outcomes for bladder cancer patients. Patients will be randomized to either WLC TURBT or BLC TURBT, and outcomes will be measured using standard-of-care testing with cystoscopy and cytology, along with minimal residual disease (MRD) burden evaluation using urine next-generation sequencing.
A phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC)
This is a phase 2 open-label two cohort study of durvalumab plus monalizumab in patients with BCG-unresponsive or BCG-exposed CIS NMIBC. Arm A will enroll 43 participants who have cancer in situ (CIS) with or without high grade papillary urothelial cancer. Arm B will enroll 17 participants who do not have cancer in situ (CIS) but do have high grade papillary urothelial cancer. Eligible patients will be enrolled to receive up to 13 cycles of monthly combination of monalizumab and durvalumab. Both monalizumab and durvalumab will be administered intravenously (IV) every 28 days.
This is a phase II, single arm, Simon two-stage design, trial, enrolling patients with cisplatin ineligible MIBC and/or those patients who decline cisplatin based NAC. Assess rates of pathologic downstaging and quality of life in MIBC cisplatin-ineligible/declined patients when IVC is added to gemcitabine-carboplatin NAC.
This phase Ib/II trial studies the side effects, best dose, and effectiveness of enfortumab vedotin (EV) in combination with pembrolizumab and radiation therapy for treating patients with muscle invasive bladder cancer. Standard of care treatment for muscle invasive bladder cancer is chemotherapy, to shrink the tumor before the main treatment is given (neoadjuvant), followed by surgery to remove all of the bladder as well as nearby tissues and organs (radical cystectomy). In cases where patients are not candidates for the standard of care approach or prefer a bladder sparing option, tri-modality therapy with transurethral resection of bladder tumor (TURBT) followed by combined chemotherapy and radiation therapy is used. Enfortumab vedotin is a monoclonal antibody, enfortumab, linked to an anticancer drug called vedotin. It works by helping the immune system to slow or stop the growth of tumor cells. Enfortumab attaches to a protein called nectin-4 on tumor cells in a targeted way and delivers vedotin to kill them. It is a type of antibody-drug conjugate. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Intensity-modulated radiation therapy is a type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Giving enfortumab vedotin with pembrolizumab and radiation therapy may work better in treating patients with muscle invasive bladder cancer.
This is a Phase II, single cohort study designed to evaluate outcomes in patients with muscle invasive bladder cancer (MIBC) with variant histology who receive neoadjuvant chemotherapy (NAC) with or without immunotherapy (IO) followed by trimodal therapy (TMT). Enrolled patients will undergo at least 3 cycles of NAC +/- IO (oncologist's choice) followed by a four- or six-week course of concurrent standard of care chemotherapy and radiation therapy. These patients will be compared with historical controls of patients with a diagnosis of pure urothelial carcinoma who have undergone TMT. This study has been designed to test the hypothesis that variant histology TMT can be delivered within 45 days of NAC +/- IO and is therefore a viable option in patients who are risk of systemic disease spread.
STAR-EV will evaluate the combination of enfortumab vedotin plus radiotherapy (RT) as neoadjuvant treatment for muscle invasive bladder cancer prior to radical cystectomy surgery. The study will use "dose escalation" to evaluate the safety and efficacy of study treatment at three dose regimens: Level 0: EV treatment followed by RT to the bladder Level 1: EV treatment with RT starting on Cycle 2, Day 15 Level 2: EV treatment with RT starting on Cycle 1, Day 15 Following completion of EV+RT neoadjuvant therapy, all subjects will undergo surgery as part of routine care.
This is a pilot, single arm, prospective study that aims to validate the accuracy of the VI-RADS score obtained via multi-parametric magnetic resonance imaging (mpMRI) compared to pathologic cancer stage obtained via diagnostic transurethral bladder tumor resection (TURBT) as well as compare the clinical and quality of life outcomes between these diagnostic modalities in patients with suspected muscle-invasive bladder cancer (MIBC).
This Phase 3, single-arm, multicenter study will evaluate the efficacy and safety of UGN-103, a novel formulation of UGN-102, instilled in the urinary bladder of patients with low-grade non-muscle invasive bladder cancer (LG-NMIBC).
This phase II trial tests how well the combination of futibatinib and durvalumab given before cystectomy works in treating patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based therapy. Cisplatin-based therapy is the standard of care for patients with MIBC. However, many patients cannot receive standard therapy due to poor renal function, peripheral neuropathy, poor functional status, or clinically significant heart failure. Futibatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Radical cystectomy is a surgery to remove all of the bladder as well as nearby tissues and organs. Giving futibatinib in combination with durvalumab before surgery may be an effective treatment option for patients with MIBC who are ineligible for cisplatin-based therapy.
The purpose of this study is to evaluate the safety and tolerability of talectrectinib as treatment for Stage IV ILC with CDH1 mutation