This phase II trial tests how well photoradiation with verteporfin and pembrolizumab plus standard of care chemotherapy works in treating patients with pancreatic cancer that cannot be removed by surgery (unresectable), that has spread to nearby tissue or lymph nodes (locally advanced) or to other places in the body (metastatic). Photoradiation uses light activated drugs, such as verteporfin, that become active when exposed to light. These activated drugs may kill tumor cells. Vertoporfin may also increase tumor response to immunotherapy. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as modified fluorouracil, leucovorin, irinotecan, and oxaliplatin (mFOLFIRINOX), 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. Photoradiation with verteporfin and pembrolizumab plus standard of care chemotherapy may kill more tumor cells in patients with unresectable, locally advanced or metastatic pancreatic cancer.
Feasibility and efficacy of combined modality intervention using chemotherapeutic agent gemcitabine with anti-angiogenic peptide vaccination targeting VRGFR1 should be determined in case of advanced/inoperable or therapy-resistant pancreatic cancer patients.
Gemcitabine 1,000mg/m2 BSA will be administered on day1, day8, day15, day29, day36, day43, respectively.
HLA-A*2402-restricted VEGFR1-derived peptide (VEGFR1-A24-1084; SYGVLLWEI) emulsified with Montanide ISA51 will be subcutaneously injected twice weekly for 8weeks (total 16 doses).
The primary objective of this study is to compare the efficacy of GEM plus Z-360 versus GEM plus placebo on the overall survival (OS) in subjects with metastatic Pancreatic Adenocarcinoma.
This is a data collection study, also referred to as a "screening" study; no investigational or standard therapy will be administered as part of this study. In order to identify subjects for the Phase I/II study, TCR001-201, patients with following histologically confirmed tumor types will be initially screened in this protocol for their somatic mutation and HLA type:
* Gynecologic cancer (ovarian or endometrial)
* Colorectal cancer
* Pancreatic cancer
* Non-small cell lung cancer (NSCLC). NSCLC includes but is not limited to squamous cell carcinoma, adenosquamous carcinoma or adenocarcinomas
* Cholangiocarcinoma Subjects' somatic mutation(s) and HLA type restriction combination will be examined against Alaunos Therapeutics Inc.'s (Alaunos) TCR library to determine if a TCR match is available for that subject. Subjects without a match will be discontinued from this protocol.
Subjects with a TCR match in the Alaunos TCR library will continue to be followed on this protocol and their clinical status will be monitored on an ongoing basis for eligibility, i.e., for progressive or recurrent disease, to enroll and receive TCR-T cell therapy on the Phase I/II study. Subjects will complete participation on this protocol when the subject enrolls on the Phase I/II study or if the subject dies.
The purpose of the study is to collect pancreatic tissue, blood and urine from adults to study pancreatic abnormalities.
The aim of this study is to establish multiomic big data under strictly collected clinical samples from tumors, adjacent normal tissue, blood, and clinical data then analyze by using integrated proteomics and genetics platform.
Purpose of this phase I/II study is to test how well LY2090314 works in combination with different chemotherapies in treating participants with metastatic pancreatic cancer.
MTC-DOX is Doxorubicin or DOX, a chemotherapy drug, that is adsorbed, or made to "stick", to magnetic beads (MTCs). MTCs are tiny, microscopic particles of iron and carbon. When DOX is added to MTCs, DOX attaches to the carbon part of the MTCs. MTC-DOX is directed to and deposited in the area of a tumor, where it is thought that it then "leaks" through the blood vessel walls. Once in the surrounding tissues, it is thought that Doxorubicin becomes ȯree from" the magnetic beads and will then be able to act against the tumor cells. The iron component of the particle has magnetic properties, making it possible to direct MTC-DOX to specific tumor sites in the liver by placing a magnet on the body surface. It is hoped that MTC-DOX used with the magnet may target the chemotherapy drug directly to liver tumors and provide a treatment to patients with cancers that have spread to the liver.
Background:
Researchers want to test if certain cells can be re-programmed into stem cells. Stem cells can keep reproducing for a long time. Cells made by stem cells can be turned into different types of cells. These include cancer-fighting cells, skin cells, etc. The stem cells generated in this study will be used to make specific tumor-fighting cells that can recognize different types of mutations in cancer cells. They may also help identify new tumor mutations that may not have been identified yet.
Objectives:
To test if a certain type of tumor-fighting cells can be re-programmed into stem cells.
Eligibility:
Participants in another Surgery Branch protocol who are at least 16 years old
Design:
Participants already gave samples of blood and/or tumor tissue in the other protocol. They do not need to come back to the clinic or give any other samples.
Participants will give consent for their samples to be used in this study.
Researchers will obtain cells from the samples. They will grow those cells in the lab. They will create stem cells from them.
Researchers will do genetic tests on the samples.
Most tests will not show important health results. But if they do, the participant will be invited to talk to a genetic counselor and get more detailed testing to confirm the results.
Some of the samples and results will be stored indefinitely. They may be used in future research. No personal information will be stored with them.
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RATIONALE: Stop-smoking plans, including counseling and nicotine replacement therapy, may help smokers quit smoking. It is not yet known whether counseling and the nicotine lozenge is more effective than counseling and the nicotine patch in helping adult smokers quit smoking.
PURPOSE: This randomized phase III trial is studying counseling and the nicotine lozenge to see how well they work compared to counseling and the nicotine patch in helping smokers quit smoking.
