14 Clinical Trials for Various Conditions
This study, ELU- FRα-1, was focused on adult subjects who have advanced, recurrent or refractory folate receptor alpha (FRα) overexpressing tumors considered to be topoisomerase 1 inhibitor-sensitive based on scientific literature, and, in the opinion of the Investigator, have no other meaningful life-prolonging therapy options available.
This phase IB trial evaluates the effect of niraparib and TSR-042 in treating patients with BRCA-mutated breast, pancreas, ovary, fallopian tube, or primary peritoneal cancer that cannot be removed by surgery (unresectable) or has spread to other places in the body (metastatic). Niraparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Immunotherapy with monoclonal antibodies, such as TSR-042, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving niraparib and TSR-042 may kill more cancer cells.
This is an open-label, First-in-Human, Phase 1/2, multicenter study to evaluate the safety and efficacy of a single dose of AVB-001. AVB-001 is an encapsulated cell product engineered to produce native human interleukin-2 (hIL-2). It is delivered intraperitoneally (IP) to patients with high grade serous adenocarcinoma of the ovary, primary peritoneum, or fallopian tube.
A study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of PF-07260437, a B7-H4 x CD3 bispecific mAb, in participants aged ≥18 years of age with advanced or metastatic breast cancer, ovarian cancer or endometrial cancer. Adult participants with other advanced or metastatic high B7-H4 expressing tumors may be considered after discussion with and approval from sponsor.
Phase 1 A: First-in-human phase 1 study to determine safety of NP-G2-044 when given orally on a daily X 28 days followed by a 14 day rest period.
Brain metastases are the most common intracranial malignancy occurring in 20-40% of all cancers, and the presence of CNS metastases is associated with a poor prognosis. As such, the median overall survival of patients with symptomatic brain lesions is a dismal 2-3 months regardless of tumor type. Because standard chemotherapy largely does not cross the blood brain barrier at a meaningful concentration, standard treatment is limited and usually involves surgical resection and/or stereotactic radiosurgery for isolated lesions and whole brain radiation for multiple lesions. Unfortunately, the median overall survival is only improved by about 6 months with this multimodality approach2, and there is a paucity of second-line therapies to treat recurrence. Furthermore, re-resection and re-radiation are often not feasible options due to concern for increasing complications or neurotoxicity, respectively. Thus, there is a dire clinical need for additional treatment options for this patient population. Checkpoint blockade therapy, in particular PD-1 and PD-L1 inhibition, has recently shown clinical efficacy in multiple types of solid tumors. The investigators propose to study the efficacy of checkpoint blockade therapy in patients with solid tumors and refractory/recurrent brain metastases. The investigators will assess the efficacy of MEDI4736, a novel PD-L1 inhibitory monoclonal antibody, in this study.
The purpose of this research study is to see if there are differences between African-American and Caucasian girls with Polycystic Ovary Syndrome (PCOS) in how their bodies respond to a type of sugar, called glucose, the body's main source of energy. PCOS is one of the most common endocrine disorders among females. Features can include anovulation (eggs are not released from the ovaries) resulting in irregular menstrual periods, excessive amounts of androgenic (male) hormones resulting in acne and hirsutism (excessive hair growth on the face and body), and polycystic ovaries (small sac-like structures \[cysts\] on your ovaries) seen on ultrasound. Girls with PCOS also have higher levels of insulin in their bodies (called hyperinsulinism) but are not able to use insulin very well (called insulin resistance) resulting in an increased risk of diabetes. Diabetes is when you have high levels of glucose (sugar) in your blood. Many studies have looked at how bodies respond to glucose and have shown that compared to Caucasians, healthy African-Americans produce much more insulin (hyperinsulinism) but are not able to use it as well (insulin resistance) in childhood, adolescence, and adulthood. Insulin is a hormone that helps glucose move from the blood into the muscles for the body to use as energy. PCOS is associated with increased levels of insulin (hyperinsulinism) and not being able to use it as well (insulin resistance). So we want to see if there is a difference in insulin production (secretion) and insulin resistance between African-Americans and Caucasians girls with PCOS. To do this, we will look at blood glucose and insulin levels in response to giving glucose in African-American and Caucasian girls who have PCOS. The results of this study may ultimately help to more effectively target treatment therapy in individuals with PCOS that have increased insulin secretion and/or increased insulin resistance.
This is a Phase 1, open-labeled, non-randomized, multi-center, competitive enrollment and dose-escalation study of ALT-801, the study drug. The purpose of this study is to evaluate the safety, determine the maximum-tolerated dose (MTD) and characterize the pharmacokinetic profile of ALT-801 in previously treated patients with progressive metastatic malignancies. ALT-801, a recombinant fusion protein with a interleukin-2 (IL-2) component, has a targeting mechanism that recognizes tumor cells with a specific tumor marker.
This study is for people whose cancer: * has resisted chemotherapy * are taking a break from chemotherapy * or are looking for an alternative to the toxic effects of chemotherapy The trial is looking to see if a very low carbohydrate diet can inhibit the growth of certain cancers. The two major goals of the RECHARGE study are to determine: * whether a very low carbohydrate diet can help participants reduce the amount of cancer in their bodies (as measured by a PET scan at the beginning and end of the study) * whether participants can feel well while maintaining their weight on a very low carbohydrate diet This research study is for people with advanced cancers who decline chemotherapy or want to take a break from chemotherapy and have cancers that primarily feed on blood sugar. Examples of such cancers include metastatic breast cancer, colon cancer, cervical and uterine cancers, ovarian cancers, and many others. The investigators' intervention consists of a 28-day diet of high protein foods such as fish, poultry, meats, eggs and cheese as well as plenty of vegetables. Participants may eat as much of the high protein foods as they wish and can eat up to two cups of vegetables per day. Participants strictly eliminate carbohydrate-containing foods. These foods include all starches and sweets (breads, pasta, rice, potatoes, cereals, fruit, cakes, candies, soda with sugar, etc.).
The purpose of this clinical trial is to look at the effectiveness of prescribing yoga classes to patients with dysmenorrhea (irregular or painful periods), or other menstrual disorders on patients' self reported pain and quality of life. Patients will be recruited from primary care clinics around Illinois, including Carle Hospital. This is a randomized trial in which patients will first be randomized into the control or intervention group. Patients in the control group will undergo usual care and be surveyed at baseline, 3 months, 6 months and 9 months. Patients in the control group will be offered the 3 months of yoga therapy complimentary after completing the 9 month control. Control patients who choose to participate in the yoga therapy will be asked to also complete the surveys at the end of the 3 month yoga intervention. Patients in the intervention group will first undergo 3 months of regular care and then 3 months of biweekly yoga classes. Participants will complete surveys at baseline, 3 months (after of control care), 6 months (after 3 months of biweekly yoga classes), 9 months, and 12 months (after 6 months of observation and optional yoga practice).
NUV-868-01 is a first-in human, open- label, Phase 1/2 dose escalation and expansion study in patients with advanced solid tumors. The Phase 1 and 1b portions include patients with advanced solid tumors and are designed to determine the safety and the dose(s) of NUV-868 to be used as monotherapy and in combination with olaparib or enzalutamide for the Phase 2 portion. In Phase 2, NUV-868 in combination with olaparib or enzalutamide will be given to determine the safety and efficacy of these study treatments. One cohort of patients (with enzalutamide-naïve metastatic castration-resistant prostate cancer) will be randomized to receive either NUV-868 monotherapy, enzalutamide monotherapy, or the combination of NUV-868 + enzalutamide. Patients will self-administer NUV-868 orally daily in 28-day cycles as monotherapy in Phases 1 and 2. In Phases 1b and 2, patients will self-administer NUV-868 orally daily in 28-day cycles in combination with olaparib or enzalutamide daily at standard prescribed doses (Phase 1b) or at the recommended Phase 2 combination dose (RP2cD) that is determined in Phase 1b. Patients will be treated until disease progression, toxicity, withdrawal of consent, or termination of the study.
Determine the safety and effectiveness of Lu-177 DOTATOC in adult subjects with somatostatin receptor-expressing Pulmonary, Pheochromocytoma, Paraganglioma, Unknown primary, and Thymus neuroendocrine tumors or any other non-.GEP-NET. The treatment regimen will consist of 4 doses of 200 (±10%) mCi 177Lu-DOTATOC administered at 8+/- 1-week intervals.
The purpose of this study is to determine the highest safe dose of rapamycin when given with a fixed amount of grapefruit juice.
The purposes of this study are: 1. To assess the maximum tolerated dose of low-dose UART(Upper Abdominal Radiation Therapy ) or WART(Whole Abdominal Radiation Therapy) given in combination with standard fixed dose-rate Gemcitabine in patients with advanced gastrointestinal (GI) or ovarian tumors (Phase I). 2. To assess response rate and survival in advanced upper GI tumors following completion of therapy (Phase II).