Phase II Trial of Vaginal Cuff Brachytherapy Followed by Adjuvant Chemotherapy With Carboplatin and Dose Dense Paclitaxel in Patients With High-Risk Endometrial Cancer
The purpose of this study is to determine the feasibility of treatment in patients with high risk endometrial cancer treated by vaginal cuff brachytherapy followed by 3 cycles of dose dense paclitaxel and carboplatin chemotherapy.
NCT03189446 — Endometrial Cancer
Status: Completed
http://inclinicaltrials.com/endometrial-cancer/NCT03189446/
Scale Down: A Randomized, Controlled Weight Management Intervention for Women With Endometrial Cancer
This proposal will pilot a weight management program for patients with endometrial cancer, the cancer most associated with obesity. If successful, this pilot could be expanded to include obese women with other gynecologic cancers (ovarian and cervical) and could be expanded and adapted for use not only upon completion of treatment, but during chemotherapy or radiation. Furthermore, other obstetricians and gynecologists could use this strategy for obese women as a practical cancer prevention strategy for obesity-associated cancers.
NCT03169023 — Endometrial Cancer
Status: Completed
http://inclinicaltrials.com/endometrial-cancer/NCT03169023/
Phase I Trial of Intravenous Administration of Vesicular Stomatitis Virus Genetically Engineered to Express Thyroidal Sodium Iodide Symporter (NIS) and Human Interferon Beta (hIFNb), in Patients With Metastatic or Recurrent Endometrial Cancer
This phase I trial studies the side effects and best dose of vesicular stomatitis virus-human interferon beta-sodium iodide symporter (VSV-hIFNbeta-NIS) with or without ruxolitinib phosphate in treating patients with stage IV endometrial cancer or endometrial cancer that has come back. The study virus, VSV-hIFNbeta-NIS, has been changed so that it has restricted ability to spread to tumor cells and not to healthy cells. It also contains a gene for a protein, NIS, which helps the body concentrate iodine making it possible to track where the virus goes. VSV-hIFNbeta-NIS may be able to kill tumor cells without damaging normal cells. Ruxolitinib phosphate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving VSV-hIFNbeta-NIS with ruxolitinib phosphate may work better in treating patients with endometrial cancer compared to VSV-hIFNbeta-NIS alone.
NCT03120624 — Recurrent Endometrial Carcinoma
Status: Active, not recruiting
http://inclinicaltrials.com/recurrent-endometrial-carcinoma/NCT03120624/
A Phase 2 Study of Single Agent ONC201 in Recurrent or Metastatic Endometrial Cancer
ONC201 is a small molecule which selectively targets the G protein-coupled receptor DRD2. Downstream of target engagement, ONC201 activates the integrated stress response (ISR) in tumor cell leading to inactivation of Akt and extracellular signal-regulated kinase (ERK) signaling as well as induction of the TRAIL pathway. ONC201 also inhibits dopamine receptor 2 (DRD2), resulting in anti-tumor responses in preclinical models. Single agent ONC201 has been examined in open-label Phase I studies in patients with advanced, treatment refractory solid malignancies. Due to its differential anti-proliferative and pro-apoptotic response in tumor cells, treatment was overall well tolerated, and the recommended phase II dose of ONC201 was set at 625mg every three weeks. An additional dose-escalation phase I study (NCT02609230) is further evaluating weekly versus three week dosing in patients with advanced solid tumors and multiple myeloma. Preliminary data from these phase I studies suggests a possible clinical benefit in patients with advanced, chemo-refractory endometrial cancers, with at least one mixed response noted in a patient with clear cell histology. Hypothesis: Single agent ONC201 will demonstrate clinical benefit in women with recurrent or metastatic endometrial cancers, especially in those women with alterations in the Phosphoinositide 3 kinase (PI3K)/Akt/mammalian target of Rapamycin (mTOR) pathway.
NCT03099499 — Endometrial Cancer
Status: Terminated
http://inclinicaltrials.com/endometrial-cancer/NCT03099499/
Effect of a Lifestyle Intervention on Nutritional Status and Prognosis of Endometrial Cancer Survivors
The objective of the present study is to implement and evaluate the effect of a counseling program to promote healthy eating and practice of physical activity in the nutritional status, quality of life and prognosis of women Type I (endometrioid) endometrial cancer.
NCT03095664 — Obesity
Status: Suspended
http://inclinicaltrials.com/obesity/NCT03095664/
Endometrial Cancer and Obesity: An Exercise and Diet Intervention for Weight Loss
This pilot clinical trial studies exercise and diet intervention in promoting weight loss in obese patients with stage I endometrial cancer. Exercise and diet may cause weight loss and minimize the risk of gynecologic surgery related to being overweight in patients with endometrial cancer.
NCT03042897 — Obesity
Status: Withdrawn
http://inclinicaltrials.com/obesity/NCT03042897/
A Randomized Surgical Window Pilot Investigation of the Relationship of Short Term Medroxyprogesterone Acetate (NSC #26386) Compared to Medroxyprogesterone Acetate Plus Entinostat (NSC #706995) on the Morphologic, Biochemical, and Molecular Changes in Primary Endometrioid Adenocarcinoma of the Uterine Corpus
This randomized surgical window trial evaluates the effect of adding entinostat to medroxyprogesterone acetate before surgery works on progesterone receptors on endometrioid endometrial tumors. Medroxyprogesterone acetate is a progesterone, a hormone produced by body normally. Entinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving medroxyprogesterone acetate with or without entinostat may effect tumors from endometrioid endometrial cancer.
NCT03018249 — FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma
Status: Completed
http://inclinicaltrials.com/figo-grade-2-endometrial-endometrioid-adenocarcinoma/NCT03018249/
A Phase II, Open Label Study of the Poly(ADP-ribose) Polymerase Inhibitor Niraparib in Monotherapy or in Combination With Anti-PD1 Inhibitor TSR-042 in Recurrent Endometrial Cancer
This is a phase 2 study of investigational drug niraparib and TSR-042 in patients with advanced/recurrent endometrial cancer. The purpose of this study is to determine whether blocking a protein called poly (ADP-ribose) polymerase (PARP) with niraparib provides clinical benefit in patients with recurrent endometrial cancer, as well as to explore the possible impact of phosphatase and tensin homolog (PTEN) loss (loss of function of the PTEN gene) on blocking PARP with niraparib.
NCT03016338 — Endometrial Cancer
Status: Active, not recruiting
http://inclinicaltrials.com/endometrial-cancer/NCT03016338/
A Phase 2 Trial of Durvalumab [MEDI4736](Anti-PD-L1 Antibody) With or Without Tremelimumab (Anti-CTLA-4 Antibody) in Patients With Persistent or Recurrent Endometrial Carcinoma and Endometrial Carcinosarcoma
This study will test the safety and efficacy of the experimental drug called durvalumab with or without another experimental drug called tremelimumab in endometrial cancer. Radiologic tumor assessment will be repeated every 8 weeks +/- 7 days for the first 48 weeks and then every 12 weeks +/- 7 days until PD. For patients who remain progression free 2 years post completion of protocol directed treatment, every 6 months +/- 1 month. irRECIST assessments will only be completed for patients continuing treatment beyond PD.
NCT03015129 — Endometrial Cancer
Status: Completed
http://inclinicaltrials.com/endometrial-cancer/NCT03015129/
Mirena® ± Metformin as Fertility-preserving Treatment for Young Asian Women With Early Endometrial Cancer
Primary objective To discover the efficacies of levonorgestrel-containing intrauterine device (LNG-IUS, Mirena®), with or without metformin, as fertility-preserving treatment for grade 1 endometrioid adenocarcinoma of endometrium, cT1aN0M0 with presumed no myometrial invasion on image study (MRI preferred). Secondary objectives 1. To discover the morphological and molecular change in the endometrium tumor before and after treatment 2. To discover the effectiveness of adding oral progestin to subjects who show no good response to assigned 3. To compare (1) the systemic effects, including body weight change, neuropsychiatric alternation, GI disturbance, skin disorder, change in serum metabolic and hepatic markers between the two study patient groups; (2) The rate of long-term success defined as (a) sustained remission of >= 12 months starts from the histologic documentation of complete remission (b) rate of pregnancy and (c) alive baby delivery, based on time-to-event analysis. 4. Molecular markers and their expression before, during and after treatment, including progesterone B receptor, progesterone A receptor, estrogen receptor, Ki67, PTEN and its related markers, Bcl2 and its related markers and other developing markers. This is to discover prediction markers to medical treatment.
NCT02990728 — Endometrial Cancer
Status: Enrolling by invitation
http://inclinicaltrials.com/endometrial-cancer/NCT02990728/