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The purpose of this study is to see whether participants who are assigned to a multimodal prehabilitation intervention during chemotherapy are able to adhere with exercise and nutrition program to prepare for their cancer surgery.
This phase I trial is evaluating a new imaging tracer (68Ga-FAPi-46) with positron emission tomography (PET)/computed tomography (CT) to determine where and to which degree the tracer (68Ga-FAPi-46) accumulates in normal and cancer tissues (the biodistribution) in patients with solid tumors or hematologic (blood) cancers. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 68Ga-FAPi-46. Because some cancers take up 68Ga-FAPi-46, it can be seen with PET. CT utilizes x-rays that traverse the body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in a patient's body. Combining a PET scan with a CT scan can help make the image easier to interpret. PET/CT scans are hybrid scanners that combine both modalities into a single scan during the same examination.
This is a randomized, adaptive, open label, multicenter trial to evaluate the safety and efficacy of intraperitoneal (IP) IMNN-001 plus chemotherapy compared to chemotherapy alone.
This clinical trial compares the effect of an automated personalized physical activity intervention supported by wearable technology to standard of care on physical activity levels and quality of life in patients with stage II- IV ovarian, primary peritoneal, fallopian tube cancer or endometrial cancer that is newly diagnosed. Physical activity is a modifiable risk factor for the prevention and treatment of many diseases. In fact, increased levels of physical activity have been shown to decrease the risk of some cancers as well as increase overall survival in some cancers. Currently, standard of care guidelines include participation in at least 150 minutes of moderate exercise weekly. An automated personalized physical activity intervention may increase physical activity, enhance quality of life, and improve physical function and daily living activities compared to standard recommendations in patients with stage II-IV ovarian, primary peritoneal, fallopian tube or newly diagnosed endometrial cancer. This trial also evaluates the impact of physical activity on the gut microbiome and immune function. The microbiome is the collection of tiny organisms, like bacteria, that live in and on the body, especially places like the gut. These microorganisms play an important role in health. Information gathered from this study may help understand how the gut microbiome and physical activity influences the immune system in patients with stage II-IV ovarian, primary peritoneal, fallopian tube or newly diagnosed endometrial cancer.
Study CP-MGD019-03 is an open-label study of lorigerlimab in participants with platinum-resistant ovarian cancer (PROC) or clear cell gynecologic cancer (CCGC). Approximately 60 participants will be enrolled. The study will assess the efficacy and safety of lorigerlimab in participants with PROC or CCGC. Participants will receive lorigerlimab by intravenous (IV) infusion on Day 1 of every 21-day treatment cycle. Treatment cycles will continue until progression of cancer, unacceptable side effects, withdrawal of consent by the participant, or the study ends. Participants will be monitored closely for side effects by physical exam and routine laboratory tests every cycle. Tumor status will be checked approximately every 9 weeks for the first year, then every 12 weeks for the duration of treatment. Participants will have a safety followup performed within 30 days after treatment discontinuation. Participants who discontinue study treatment for reasons other than progression of cancer, will continue CA-125 and tumor assessments every 12 weeks. Participants who discontinue study treatment for progression of cancer will enter the 6-month survival follow up portion of the study.
This phase II trial compares the effect of folate receptor alpha dendritic cells (FRαDCs) to placebo in treating patients with stage III or IV ovarian, fallopian tube or primary peritoneal cancer. FRαDCs, a dendritic cell vaccine, is made from a person's white blood cells. The white blood cells are treated in the laboratory to make dendritic cells (a type of immune cell) mixed with folate receptor alpha (FRalpha), a protein found in high levels on ovarian tumor cells. FRαDCs work by boosting the immune system to recognize and destroy the tumor cells by targeting the FRalpha protein on the tumor cell. Placebo is an inactive substance that looks the same as, and is given the same way as, the active drug or treatment being tested. The effects of the active drug are compared to the effects of the placebo. Giving FRαDCs may work better in preventing or delaying recurrence compared to placebo in patients with stage III or IV ovarian, fallopian tube, or primary peritoneal cancer.
The phase II trial evaluates the effectiveness of cryocompression therapy alone or in combination with cilostazol in preventing paclitaxel-induced peripheral neuropathy (numbness, pain or tingling in the feet and hands) for patients with gynecologic cancers. Peripheral neuropathy is a common side effect of many chemotherapeutic agents, including paclitaxel. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Cryocompression is a therapy that combines compression garments or dressings with cooling of the treated area. Cilostazol is in a class of medications called platelet-aggregation inhibitors (antiplatelet medications). It works by improving blood flow to the legs. Giving cilostazol together with cryocompression may be safe and tolerable in treating patients with gynecological cancers.
This prospective, observational cohort study will evaluate the extent of associations between self-reported pro- or anti- inflammatory dietary intake patterns for one month before induction chemotherapy for gynecological cancer or neo/adjuvant chemotherapy for breast cancer and baseline serum hepcidin concentrations. Associations between hepcidin concentration and relative dose intensity (RDI) of chemotherapy will also be evaluated.
This phase I trial tests the safety, side effects, best dose of MUC1-activated T cells in treating patients with ovarian cancer that has come back after a period of improvement (relapsed) or that remains despite treatment (resistant). T cells are infection fighting blood cells that can kill tumor cells. The T cells given in this study will come from the patient and are made in a laboratory to recognize MUC1, a protein on the surface of tumor cells that plays a key role in tumor cell growth. These MUC1-activated T cells may help the body's immune system identify and kill MUC1 expressing ovarian tumor cells.
This study is researching an experimental CAR T cell therapy called 27T51, referred to as study drug. The study drug is a MUC16 targeting immune cell therapy focused on adult female participants with recurrent or difficult to treat epithelial ovarian, primary peritoneal or fallopian tube cancer. This study has two (2) major parts: Phase 1a Dose Escalation and Phase 1b Dose Expansion. The aim of the dose escalation part will be to test the safety of 27T51 in a small number of participants to find the highest dose given to humans without unacceptable side effects. The aim of the dose expansion part will be to test 27T51 at the established dose level(s) from the dose escalation part and may include other medications given in combination with 27T51. Information collected from this study will help researchers understand more fully whether this immune cell therapy, also known as CAR T cell therapy, can be safely used to treat solid tumors such as ovarian cancer.