A Phase 1b, Open-Label, Safety, Pharmacokinetic, and Pharmacodynamic Study of an Anti-super-enhancer Minnelide Once a Day on Days 1 to 5, Days 8 to 12 and Days 15 to 19 Along with Abraxane Plus Gemcitabine in Patients with Metastatic Adenocarcinoma of the Pancreas
Researchers are looking for better ways of understanding and treating pancreatic cancer. The purpose of this study is to see how useful it is to look for changes and characteristics in your genes (molecules that contain instructions for the development and functioning of the cells) and the genes within the tumour. These characteristics may be useful in choosing treatments for patients in the future. Changes (mutations) in genes have been shown to be an important characteristic in cancers. Looking at differences in genes in patients with advanced pancreatic ductal adenocarcinomas and comparing this information with response to their initial chemotherapy treatment may help to learn which treatments may be better for certain patients after initial treatment.
The purpose of this study is to establish the safest doses of an investigational drug called MORAb-009 in subjects with pancreatic cancer, mesothelioma, or certain types of ovarian or lung cancer. MORAb-009 is a monoclonal antibody that is directed to an antigen on the surface of these cancers.
This trial is a prospective, exploratory and descriptive study. The primary objective is to identify early diagnostic biomarkers in patients with TIPMP based on the analysis of Treg lymphocyte subpopulations and epigenetic signatures, and the secondary objective is to characterize the biological processes underlying the transformation of a pre-neoplastic lesion into established ADPC.
Title: Phase II study of hypofractionated radio-chemotherapy with gemcitabine plus oxaliplatin for unresectable nonmetastatic locally advanced pancreatic cancer.
Protocol code: IRST157.01
Phase: II
Study Design: monocentric, prospective, open-label not randomized trial.
Description of Study Treatment: radio-chemotherapy schedule
* GEMOX: Gemcitabine (GEM) 1000 mg/m2, day 1, and Oxaliplatin (OX) 100 mg/m2, day 2, every 2 weeks for 4 cycles.
* Hypofractionated radiotherapy (35 Gy in 7 fractions in 9 consecutive days, one session per day excluding Saturday and Sunday) administered 15 days after the 4th chemotherapy cycle.
* Further 4 cycles of GEMOX, starting 7-15 days after the end of the radiotherapy.
Objectives:
Step A: primary objective = to evaluate the safety of radiotherapy treatment. Secondary objective = the control of IM (internal margin) intra-fraction.
Step B: primary objective = to evaluate the proportion of the resectable patients after radio-chemotherapy. Secondary objectives = overall Response Rate (ORR); safety profile of combinated treatment;overall survival (OS); local progression free survival (LPFS) and progression free survival (PFS).
Statistical Considerations:
Step A:
Assuming that the probability to observe a toxicity involving the radiotherapy treatment discontinuation with the new treatment is less than 20%, 11 patients are to be evaluated for toxicity. If no toxicity involving the radiotherapy treatment discontinuation will be observed in 11 patients, the treatment can be considered safe with a probability > 90%. If 1 toxicity involving the radiotherapy treatment discontinuation will be observed, 7 more patients needs to be recruited. If no further toxicity involving the radiotherapy treatment discontinuation occurs, the treatment could be considered safe with a probability ≥ 90%.
If 2 or more toxicity involving the radiotherapy treatment discontinuation on 11 patients or 2 or more toxicity involving the radiotherapy treatment discontinuation on 18 patients will be observed, the study will be stopped because not safe and another kind of radiotherapy schedule must be designed.
Step B:
If the radiotherapy treatment will be considered no toxic, the study will continue in Step B : the goal of this phase II study is to increase the proportion of resectable patients of at least 15% with the new radio-chemotherapeutic treatment. By using the single-stage design (Gehan EA, J Chron Dis 1961) a total of 40 patients is required to be recruited in 2 years, and a further one-year period of follow-up is requested. If at least 7 patients out of 40 enrolled will be resectable, the hypothesis that the proportion of resectable patients will be less or equal to P1 (P1=the proportion of resectable patients with the new radio-chemotherapeutic treatment) will be refused and the treatment could be considered active.
This study is a single-center, single-arm, open-label, phase II clinical trial designed to evaluate the efficacy and safety of Paclitaxel Polymeric Micelles for Injection for the treatment of patients with advanced pancreatic adenocarcinoma, cholangiocarcinoma, lung cancer, gastric cancer, esophageal carcinoma, or breast cancer that are resistant to Taxanes.
Subjects are given paclitaxel polymeric micelles for injection, three weeks constitutes one cycle of treatment.
If subject does not develop disease progression , the subject continues treatment until disease progression (RECIST 1.1) or develops an intolerable toxicity, initiation of a new anti-cancer drug, withdrawal from the study, death, or loss of follow-up.
This is a single-arm, small-sample clinical study with the primary efficacy goal of objective remission rate (ORR). The parameters of the trial were set: assuming a class I error of 0.025 unilaterally, power=90%, and a 15% improvement in ORR for objective remission rate, a total of 20 subjects would be required, and a total of 25 would be required for enrolment, taking into account a 20% shedding.
This study aims to find a correlation between cytokines levels and malignancy potential of different cystic types.
Background:
* Malignant mesothelioma is a malignancy arising from the mesothelial cells of the pleura, peritoneum, pericardium, or tunica vaginalis.
* Mesothelioma accounts for 0.10% of deaths annually in the United States. Malignant pleural mesothelioma is the most common of these, comprising of 80% of the cases with an annual incidence of about 2,500 in the United States.
* The median survival from diagnosis of pleural mesothelioma is approximately 12 months. The majority of patients present with stage III or IV disease with 85-90% of patients considered unresectable at diagnosis.
* Peritoneal mesothelioma has a better prognosis than pleural mesothelioma; nevertheless, patients undergoing therapy for peritoneal mesothelioma have few well-studied treatment options due in large part to the rarity of the disease.
Objectives:
-To allow sample acquisition for use in the study of mesothelioma.
Eligibility:
* All patients age greater than or equal to 2 years with malignant mesothelioma
* Must be able and willing to provide informed consent if 18 or over; parent or guardian must be able and willing to provide consent for patients under the age of 18
Design:
* Up to 1000 subjects will be enrolled.
* Patients will be followed to determine the course of disease and to record any treatment received for mesothelioma.
* Patients will undergo sampling of blood, urine, tumor and abnormal body fluids for tissue banking.
* Studies which may be performed on banked material include genetic and genomic studies, establishment of cell cultures and immunologic studies.
The purpose of this study is to determine the highest safe dose of rapamycin when given with a fixed amount of grapefruit juice.
This phase I trial studies the side effects and best dose of SOR-C13 in treating patients with solid tumors that have spread to other places in the body (advanced) and does not respond to treatment. Drugs used in chemotherapy, such as SOR-C13, 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.
