This trial is evaluating whether Durvalumab will improve 1 primary outcome and 6 secondary outcomes in patients with Leiomyosarcoma. Measurement will happen over the course of 3 years.
This trial requires 90 total participants across 2 different treatment groups
This trial involves 2 different treatments. Durvalumab is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.
"In the majority of cases, leiomyosarcoma is a sporadic benign tumor of the leiomyomata. It is usually discovered on histopathology. The occurrence of it is higher among women who have had a molar pregnancy. Smoking may be a protective factor." - Anonymous Online Contributor
"It is common for women with uterine leiomyofibroids to have a palpable mass. However, the most common signs of leiomyosarcoma are fever, weight loss and malaise. Because leiomyosarcoma does not often produce symptoms and is, by its nature, a silent disease, it is important for physicians and patients to suspect this diagnosis as an underlying cause of fever, weight loss and malaise." - Anonymous Online Contributor
"Treatment of a limb sarcoma with surgery and radiation is a realistic goal, especially in a very-low-grade, early-stage primary lesion. However, most such patients continue to have local recurrence. At this time, no adjuvant therapy has been shown to improve local control or metastasis-free survival. Therefore, the focus is on improving local control of the disease by use of local radiotherapy, chemotherapy, and a biologic or immunologic intervention. This approach may produce long-term local control, progression-free survival, and enhanced metastasis-free survival rates in the future." - Anonymous Online Contributor
"This retrospective study shows the treatment of leiomyosarcoma in our institution which includes surgery, chemotherapy, radiation, and targeted therapy. Tumor type was no predictor of the treatment or survival. Further studies with larger number of cases will be needed for additional analysis of treatment response." - Anonymous Online Contributor
"The leiomyosarcoma rate in the United States was 3.8 per million persons aged 15 years and older during 2004-2006. This rate was nearly doubled among women over age 60 compared with those in their 30s or early 40s. While leiomyosarcoma may occur at any age and at any site in the body, incidence and prevalence peaks between age 50 and 68 years." - Anonymous Online Contributor
"These cases demonstrate a wide spectrum of clinical and biological features of leiomyosarcoma. We suggest that a pathophysiology-oriented approach is needed to treat this disease. It is important to note that with effective and early therapy, this disease can often be cured." - Anonymous Online Contributor
"As in the pediatric population, age at diagnosis > or =40 is the most important predictor of improved prognosis in the adult population. The age at diagnoses 45-74 years is also an important predictor for improved survival in adult cases of leiomyosarcoma. Although leiomyosarcoma is regarded as a dismal disease, it has favorable prognosis compared with Ewing sarcoma and soft tissue sarcoma." - Anonymous Online Contributor
"Durvalumab may improve the quality of life of patients with leiomyosarcoma. As of September 2019, the drug is not approved by either FDA or EMA for treatment of patients with leiomyosarcoma. It would be considered for treatment in a clinical trial.\n" - Anonymous Online Contributor
"Durvalumab is used to treat patients with metastatic leiomyosarcoma (mesenchymal tumors of smooth muscle) who do not respond to previous standard therapy. It has been well tolerated without a significant increase in toxicity. However, patients on the monotherapies have increased risk of progressive disease and death over patients receiving combination therapy. Furthermore, it has been shown to prolong survival in several studies using this as single/combination therapy. In fact, patients treated with durvalumab as a combination therapy have shown increased overall survival. The recommended dose of 200 μg per square meter every 2 weeks is efficacious." - Anonymous Online Contributor
"The therapeutic role of durvalumab in refractory/relapsed solid tumors has recently been demonstrated in randomized controlled trials and observational cohorts. This agent has now begun its development at a clinical-trial center in Paris. As data are being collected from this phase IIb trial, the role of durvalumab in metastatic solid tumors is being investigated." - Anonymous Online Contributor
"The incidence of uterine leiomyosarcoma is very low. Its primary cause among white women younger than 35 years is uterine fibroids. In all age groups, the primary cause among black women is ovarian cancer. Atypical leiomyosarcoma seems to be associated with uterine leiomyoma or fibroids in black women but not in white women. The most common presenting symptom is vaginal bleeding, but it can happen at any age." - Anonymous Online Contributor
"This is the first report on side effects from clinical trial data of Durvalumab in metastatic leiomyosarcoma. As a monoclonal antibody, Durvalumab has one of the lowest incidence of common adverse event." - Anonymous Online Contributor