This is a Phase I clinical trial evaluating an investigational treatment called IDOV-Immune, a type of oncolytic virus therapy, for adults with advanced solid tumors that have not responded to standard treatments. Oncolytic viruses are designed to infect and destroy cancer cells and have the potential to stimulate the immune system to fight the tumor.
The purpose of this study is to determine the safety of IDOV-Immune, how well it is tolerated, and to identify the highest dose that can be safely given. Researchers will also study how the drug behaves in the body, how the immune system responds to it, and whether it shows any signs of shrinking tumors.
Participants will receive a single intravenous (IV) infusion of IDOV-Immune and will be closely monitored for side effects and any changes in their cancer.
This study is being conducted at multiple sites in the United States and Australia.
The dynamics of immune cells by CCRT/Durvalumab will be uncovered. The combination of Durvalumab with concurrent chemoradiotherapy (CCRT/gemcitabine)) as neoaduvant treatment in resectable or borderline resectable pancreatic cancer is feasible and efficacious.
The combination of Durvalumab with cytotoxic chemotherapy (gemcitabine) as an adjuvant treatment is feasible and efficacious.
To assess the effect of Neoadjuvant CCRT with Gemcitabine/Durvalumab followed by adjuvant Gemcitabine/Durvalumab in resectable or borderline resectable pancreatic cancer
Primary endpoint:
2 year-DFSR (disease-free survival rate) Secondary endpoints
* Efficacy: 2 year-OSR (overall survival rate), disease-free survival, overall survival, overall response rate (RECIST 1.1, ir response) after neoadjuvant CCRT, disease control rateEORTC QLQ-C30, the number of immune cells (TIL, macrophage, etc) in resected pancreatic tissue
* Safety: toxicity (CTCAE V), irAE,
Exploratory Objective(s):
* To evaluate baseline measures and changes of immune systems and regulations by neoadjuvant CCRT with gemcitabine/Durvalumab in peripheral blood and tumor tissues
* To collect and store DNA from blood (according to ethical procedures) for future exploratory research into genes/genetic variation that may influence response (ie, distribution, safety, tolerability and efficacy) to study treatments and or susceptibility to disease (optional).
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RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory into patient autologous or donor-derived T cells may make the body build immune response to kill cancer cells.
PURPOSE: This clinical trial is studying genetically engineered lymphocyte therapy in treating patients with Relapsed and/or Chemotherapy Refractory Advanced Malignancies.
This phase II trial studies how well combination chemotherapy with or without oregovomab followed by stereotactic body radiation therapy (SBRT) and nelfinavir mesylate works in treating patients with pancreatic cancer that has spread to nearby organs or tissues. Drugs used in chemotherapy, such as gemcitabine hydrochloride, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as oregovomab, can block tumor growth in different ways by targeting certain cells. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Drugs, such as nelfinavir mesylate, may make tumor cells more sensitive to radiation therapy. Giving combination chemotherapy with or without oregovomab followed by SBRT and nelfinavir mesylate may kill more tumor cells.
The main objective of this trial is to evaluate every 2 months alternating nab-paclitaxel/gemcitabine and FOLFIRI.3 versus nab-paclitaxel + gemcitabine, regarding the progression of disease at 6 months.
Pancreatic cancer is burdened by an extremely low survival rate. Survival chances reduce even further when the tumor spreads to other organs such as lymphnodes, liver or lungs. When the tumor cannot be surgically resected, the only valid curative option is represented by chemotherapy. However, therapies available to date have limited efficacy and they do not specifically target the biological characteristics of the tumor. The aim of the project is to validate a new technology called "patient-derived organoids" (PDOs) in predicting the best drugs for the treatment of pancreatic cancer based on the tumoral characteristics and behavior.
In order to generate PDOs a sample of tumoral tissue will be collected during a small surgical procedure, called laparoscopy. PDOs represent mini, three-dimensional copies of the original tumor, of which they maintain its behavior and aggressiveness. Through the DNA and RNA analysis of the tumor, the aim is to predict the best available drug by screening thousands of potentially effective compounds. Once identified, drugs will be tested in vitro on PDOs and the most efficient drug in controlling the tumor will be administered to the patient, once the present standard-of-care treatments fail.
Multiple benefits are expected from this trial. First of all, the most effective drug against their tumor based on an objective in vitro response will be provided. This might reflect in a better control of the disease and in a longer survival. Targeting the chemotherapy will also imply less side-effects due to unnecessary elevated chemotherapeutic dosages, which in turn will lead to a better compliance with the therapy. Eventually, all these aspects will reflect into a better quality of life.
Subjects who previously took part in the FT500-101 study and received allogeneic NK cell immunotherapy will take part in this long term follow-up study. Subjects will automatically enroll into study FT-003 once they have withdrawn or complete the parent interventional study.
The purpose of this study is to provide long-term safety and survival data for subjects who have participated in the parent study. No additional study drug will be given, but subjects can receive other therapies for their cancer while they are being followed for long term safety in this study.
postoperative outcomes were evaluated by using inBody test
RATIONALE: BCX-1777 may stop the growth of cancer cells by blocking the enzymes necessary for their growth.
PURPOSE: Phase I trial to study the effectiveness of BCX-1777 in treating patients who have refractory cancer.
