Individualized Response Assessment to Heated Intraperitoneal Chemotherapy (HIPEC) for the Treatment of Peritoneal Carcinomatosis From Ovarian, Colorectal, Appendiceal, or Peritoneal Mesothelioma Histologies
Background: Cytoreductive surgery (CRS) removes tumors in the abdomen. HIPEC is heated chemotherapy that washes the abdomen. CRS and HIPEC may help people with peritoneal carcinomatosis. These are tumors that have spread to the lining of the abdomen from other cancers. Researchers think they can improve results of CRS and HIPEC by choosing the chemotherapy drugs used in HIPEC. Objective: To see if HIPEC after CRS can be improved, by testing different chemotherapy drugs, using a model called the SMART (Sample Microenvironment of Resected Metastatic Tumor) System. Eligibility: Adults ages 18 and older who have peritoneal carcinomatosis that cannot be fully removed safely with surgery. Design: Participants will be screened with: Medical history Physical exam Blood and urine tests Computed tomography (CAT) scan Other imaging scans, as needed Electrocardiogram (EKG) Tumor biopsy, if needed Laparoscopy. Small cuts will be made in the abdomen. A tube with a light and a camera will be used to see their organs. Some screening tests will be repeated in the study. Participants will enroll in NIH protocol #13C0176. This allows their tumor samples to be used in future research. Participants will have CRS. As many of their visible tumors will be removed as possible. They will also have HIPEC. Two thin tubes will be put in their abdomen. They will get chemotherapy through one tube. It will be drained out through the other tube. They will be in the hospital for 7-21 days after surgery. Participants will give tumor, blood, and fluid samples for research. They will complete surveys about their health and quality of life. Participants will have follow-up visits over 5 years.
NCT04847063 — Ovarian Cancer
Status: Recruiting
http://inclinicaltrials.com/ovarian-cancer/NCT04847063/
Utilizing Photodynamic Therapy to Amplify the Response to Immunotherapy in Patients With Non-Small Cell Lung Cancer (NSCLC) With Pleural Disease or Malignant Pleural Mesothelioma (MPM) - Phase I Study
This phase I trial evaluates the side effects of intraoperative photodynamic therapy with porfimer sodium in enhancing the response to immunotherapy with an immune checkpoint inhibitor drug in patients with non-small cell lung cancer with pleural disease. Photodynamic therapy is a technique that that works by combining a photosensitizing agent (porfimer sodium in this trial) and an intense light source to kill tumor cells. Photodynamic therapy may decrease the patients' symptoms and improve their quality of life.
NCT04836429 — Lung Non-Small Cell Carcinoma
Status: Suspended
http://inclinicaltrials.com/lung-non-small-cell-carcinoma/NCT04836429/
Multicentre Observational Study Evaluating the Clinical/Biological Characteristics, Efficacy and Safety of Patients With Malignant Pleural Mesothelioma, Treated by Immunotherapy, in Real Life Setting.
The objective of this multicentre descriptive analysis is to describe the clinical and biological characteristics of patients who have received Programmed cell death 1 (anti-PD1) / (PDL1) Programmed death-ligand 1 (PDL1) immunotherapy outside of a clinical trial in terms of efficacy and safety.
NCT04775446 — Malignant Pleural Mesothelioma
Status: Completed
http://inclinicaltrials.com/malignant-pleural-mesothelioma/NCT04775446/
Prospective Evaluation of High Resolution Dual Energy Computed Tomographic Imaging, Noninvasive (Liquid) Biopsies, and Minimally Invasive Surgical Surveillance for Early Detection of Mesotheliomas in Patients With BAP1 Tumor Predisposition Syndrome
Background: A germline mutation is a change to a person s genes that is carried through their DNA. These mutations can be passed on from parents to their offspring. Germline mutations in a gene called BAP1 are linked to the development of mesothelioma and other cancers. Researchers want to follow people with these mutations to learn more. Objective: To see if researchers can improve how people who have or are suspected to have a BAP1 mutation are monitored over time. Eligibility: People age 30 and older who are suspected to have a BAP1 germline mutation. Design: Participants will be screened with a personal and family medical history. Their medical records may be reviewed. They will give a blood or saliva sample to test for a BAP1 mutation. They will get genetic counseling. To take part in this study, participants will enroll on 2 to 3 other protocols. Participants will have a physical exam. They may have a tumor biopsy. They will give blood and urine samples. They will have skin and eye exams. Some participants will have video-assisted thoracoscopy to examine the chest and lungs and diagnose suspicious areas. For this, a small camera is inserted into the chest through a small incision. Some participants will have laparoscopy to examine the organs inside the abdomen. For this, a small camera is inserted into the abdomen through a small incision. Participants will have imaging scans of the chest, abdomen, and pelvis. They may have brain scans. Participants will visit the NIH once a year for follow-up exams. Participation lasts indefinitely.
NCT04431024 — Mesothelioma
Status: Recruiting
http://inclinicaltrials.com/mesothelioma/NCT04431024/
Intrapleural Photodynamic Therapy by Video-Assisted Thoracoscopy Followed by Anti-PD-1 NIVOLUMAB in Patients With Malignant Pleural Mesothelioma - a Pilot Study
Pilot study of the feasibility of an innovative multimodal treatment combining intrapleural photodynamic therapy with videothoracoscopy followed by adjuvant immunotherapy with anti-PD-1 Nivolumab antibodies in patients with malignant pleural mesothelioma
NCT04400539 — Malignant Pleural Mesothelioma
Status: Recruiting
http://inclinicaltrials.com/malignant-pleural-mesothelioma/NCT04400539/
Phase III Randomized Trial of Pleurectomy/Decortication Plus Systemic Therapy With or Without Adjuvant Hemithoracic Intensity-Modulated Pleural Radiation Therapy (IMPRINT) for Malignant Pleural Mesothelioma (MPM)
This trial studies how well the addition of targeted radiation therapy to surgery and the usual chemotherapy treatment works for the treatment of stage I-IIIA malignant pleural mesothelioma. Targeted radiation therapy such as intensity-modulated radiation therapy or pencil beam scanning uses high energy rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as pemetrexed, cisplatin, and carboplatin, 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. Giving targeted radiation therapy in addition to surgery and chemotherapy may work better than surgery and chemotherapy alone for the treatment of malignant pleural mesothelioma.
NCT04158141 — Pleural Biphasic Mesothelioma
Status: Terminated
http://inclinicaltrials.com/pleural-biphasic-mesothelioma/NCT04158141/
A Phase Ib Clinical Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) in Combination With Cisplatin and Pemetrexed in Treatment-naive Participants With Advanced Malignant Pleural Mesothelioma (KEYNOTE-A17).
This is a multicenter, open-label, non-randomized, study of pembrolizumab in combination with cisplatin and pemetrexed in treatment of naïve participants with a histologically confirmed diagnosis of advanced/unresectable malignant pleural mesothelioma (MPM) in Japanese participants. This study will evaluate the safety, tolerability, and preliminary efficacy of pembrolizumab in combination with cisplatin and pemetrexed. The primary objective is to evaluate the safety and tolerability of treatment with pembrolizumab in combination with cisplatin and pemetrexed.
NCT04153565 — Mesothelioma
Status: Completed
http://inclinicaltrials.com/mesothelioma/NCT04153565/
A Phase II Study to Investigate the Activity and Safety of Anti-PD-L1 Antibody (Durvalumab) In ADvancEd Pretreated Malignant Pleural Mesothelioma - DIADEM Study
Malignant pleural mesothelioma (MPM) is a cancer with high mortality rate and few therapeutic options.essentially all patients usually progress and die subsequently to a first line therapyl. There is strong evidence that the immune system is deeply involved in the biogenesis of MPM and that an imbalance in pro-inflammatory cytokines and exhausted adaptive T-cell mediated immune response are the main causes of neoangiogenesis, progression and metastatisation processes.Numerous Phase II-III clinical trials are underway evaluating Durvalumab either as monotherapy or combination with evidence of activity in a wide range of solid tumors. Durvalumab has received FDA approval as second line treatment in patients with locally advanced or metastatic urothelial carcinoma. Given these prospects for PD-L1 Ab, a Phase II study is proposed in order to evaluate the activity and safety of Durvalumab in advanced pretreated MPM.
NCT04115111 — Pleura Mesothelioma
Status: Completed
http://inclinicaltrials.com/pleura-mesothelioma/NCT04115111/
Long Term Follow-up of Mesothelioma Patients and Their Family Members With Germline Mutations in BAP1 and Other Genes
Background: -A gene provides instructions to the body. Mutated genes can sometimes cause cancer. Germline mutations are those people are born with. These mutations in the BAP1 gene can cause mesothelioma and other cancers. Researchers want to study people with germline mutations of BAP1 and other genes known to cause cancer. Objective: -To learn how cancer might develop in people with certain gene mutations. Eligibility: -People ages 2 and older with a germline mutation in BAP1 or another gene that might cause cancer Design: - Participants will be screened with: - Medical and family history - Saliva test - Participants with mesothelioma will be in the NIH Group. Participants without mesothelioma can choose to be in either the NIH Group or the Remote Group. - Remote Group participants will have a medical and family history by phone. If they have tumor tissue from a previous surgery, it will be tested. They will be contacted once a year by phone. - NIH Group participants will have a baseline visit. This can take up to 4 days. They may have to stay in the area overnight. The visit will include: - Physical exam - Evaluation of tumor tissue if available - Optional tumor biopsy - Blood tests - Scans: A machine will take pictures of the body. - Photographs of skin lesions or other issues - Skin exam - Eye exam - NIH Group participants will have visits once or twice a year. These will include a physical exam, lab tests, scans, and other tests as needed. - Participants who have a confirmed mutation will be asked to contact any relatives who may be at risk and ask them about joining the study.
NCT03830229 — Mesothelioma
Status: Recruiting
http://inclinicaltrials.com/mesothelioma/NCT03830229/
Light Dosimetry for Intraoperative Photodynamic Therapy (IO-PDT) With Porfimer Sodium (Photofrin) in Patients With Malignant Mesothelioma or Non-Small Cell Lung Cancer (NSCLC), or Other Malignancies With Pleural Disease - Phase I Study
This phase I trial studies the side effects and how well light dosimetry system works during photodynamic therapy with porfimer sodium in treating participants with malignant mesothelioma , non-small cell lung cancer or any other malignancy with pleural disease undergoing surgery. Light dosimetry measures the amount of laser light given during photodynamic therapy. Photodynamic therapy uses a drug, such as porfimer sodium, that becomes active when it is exposed to light. The activated drug may kill tumor cells. Using light dosimetry for intraoperative photodynamic therapy may help doctors estimate how much light is delivered during photodynamic therapy and decide if the treatment should be stopped or continued.
NCT03678350 — Malignant Mesothelioma
Status: Active, not recruiting
http://inclinicaltrials.com/malignant-mesothelioma/NCT03678350/