Treatment Trials

21 Clinical Trials for Various Conditions

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CAR-T Intraperitoneal Infusions for CEA-Expressing Adenocarcinoma Peritoneal Metastases or Malignant Ascites (IPC)
Description

This is an open-label, dose-escalation, phase I trial of the safety and efficacy of anti-CEA intraperitoneal CAR-T infusions for treatment in patients with CEA-expressing adenocarcinoma peritoneal metastases or malignant ascites.

Conditions

Peritoneal Carcinomatosis, Peritoneal Metastases, Colorectal Cancer, Gastric Cancer, Breast Cancer, Pancreas Cancer, Carcinoembryonic Antigen

Collection of Malignant Ascites, Pleural Fluid, and Blood From People With Solid Tumors
Description

Background: Researchers want to study fluids and blood of people with cancer. The fluids are from the abdomen and around the lungs. Studying these might help researchers learn about the biology of cancer. This may lead to better ways to treat cancer. Objectives: To study the biology of cancer. Eligibility: Adults 18 and older with malignant solid tumors. Design: Participants will be screened with medical history, blood tests, and confirmation of diagnosis. Participants will have samples taken at regularly scheduled procedures. Fluids from the abdomen and/or lungs will be taken as part of the procedures. Blood will be taken separately. Participants may be asked to give more samples at future procedures.

Conditions

Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer, Cancer

Phase 1/2a Two-Arm Dose-Escalation Study of BAX69 in Subjects With Malignant Ascites of Ovarian Cancer
Description

The purpose of this study is to evaluate the safety and tolerability of BAX69 monotherapy given either as intraperitoneal (IP) infusion (Single-Route Arm); or as IP infusion after intravenous (IV) infusion (IV+IP) (Double-Route Arm), and to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for each Arm separately, in subjects with refractory ovarian cancer and recurrent malignant ascites. In both Arms, the plasma pharmacokinetics (PK) of BAX69 will be characterized, and pharmacodynamics (PD) markers will be explored in plasma and ascites. Two expansion cohorts will further assess the tolerability of the RP2D and explore clinical signs of efficacy.

Conditions

Refractory Ovarian Cancer With Recurrent Symptomatic Malignant Ascites

Feasibility Study of Intraperitoneal Bevacizumab for Palliation of Intractable Malignant Ascites
Description

This study will evaluate the safety and efficacy of intraperitoneal administration of Bevacizumab to prevent the recurrence of malignant ascites. Ten patients will receive intraperitoneal Bevacizumab 200 mg in 250 ml of normal saline for infusion every two weeks for up to six weeks, or a maximum of three treatments.

Conditions

Malignant Ascites

Palliative Care Outcomes in the Management of Malignant Ascites by Interventional Radiology
Description

Malignant ascites leads to significant morbidity in patients with terminal cancer. Paracentesis can provide relief, but repeat hospital visits, pain, and short duration of relief after paracentesis are detrimental to quality of life(QOL). Two devices are available as alternatives to paracentesis. The impact of either device on QOL has not fully been explored. A pilot nonrandomized trial measuring palliative care QOL and ascites symptom relief using validated survey instruments is proposed.

Conditions

Refractory Malignant Ascites

AZD9150, a STAT3 Antisense Oligonucleotide, in People With Malignant Ascites
Description

Background: - Some people with gastrointestinal or ovarian cancer also have ascites. That is free fluid built up in the abdomen. Researchers want to see if a new drug can affect some of the immune cells in the ascites. This may also treat the cancer. Objective: - To look at the immune markers the ascites of people with gastrointestinal or ovarian cancer. Eligibility: - Adults age 18 and older with a malignancy of the gastrointestinal tract (GI) tract or metastatic ovarian cancer. As a result, they have ascites in the abdomen. Design: * Participants will be screened with: * Medical history, physical exam, and blood tests. * Echocardiogram: sound waves make images of the heart. * Electrocardiogram: measures electrical activity of the heart. * Paracentesis: a needle will be inserted in the abdomen and will remove some of the ascites fluid. * They may have a tumor biopsy. * Participants will get AZD9150 through a vein for 3 hours. They will get this 6 times in cycle 1 and 4 times all other cycles. Each cycle is 28 days. * Each cycle, participants will: * Have a physical exam. * Have blood tests weekly. * Be asked about how they feel and any medicines they are taking. * After every 2 cycles (about every 2 months), participants will have scans and x-rays of their tumor. * Participants will have paracentesis 2 more times during the study. They will have another echocardiogram. * At the end of therapy, participants will have a physical exam and blood tests. They will be asked about how they feel and any medicines they are taking.

Conditions

Ovarian Cancer, Ovarian Neoplasms, Ascites, Gastrointestinal Cancer, Gastrointestinal Neoplasms

An Early Safety and Efficacy Study of Ascites Management: Standard Paracentesis or Early Intervention With Pleurx Catheters in Patients With Malignant Ascites
Description

The purpose of this study is to assess in a controlled prospective setting, the safety of the use of Pleurx catheters and standard therapeutic paracentesis in patients with malignant ascites.

Conditions

Malignant Ascites

A Study of Bevacizumab to Prevent Malignant Ascites
Description

The purpose of this study is to determine the effectiveness of using Bevacizumab in the prevention of recurrent malignant ascites. Ascites is a debilitating and unpleasant complication of several types of cancer. Animal and laboratory studies have shown that tumor cell production and/or increases in the amount of Vascular Endothelial Growth Factor (VEGF) is a major cause of the formation of malignant ascites. Therefore, giving patients with malignant ascites a drug that targets and neutralizes VEGF should prevent the recurrence of malignant ascites following paracentesis (a procedure to remove fluid from the abdominal cavity).

Conditions

Malignant Ascites

Trial of Sunitinib for Refractory Malignant Ascites
Description

The study is to see whether treatment with Sunitinib decreases the accumulation of ascites in patients with refractory malignant ascites.

Conditions

Ascites

AVE0005 (VEGF Trap) in Patients With Recurrent Symptomatic Malignant Ascites
Description

The primary objective of this study was to compare the time between paracenteses before and after administration of Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) in ovarian cancer participants with symptomatic malignant ascites. The secondary objectives were to further assess efficacy and safety of Aflibercept treatment, and the exploratory objectives were to assess pharmacokinetics, immunogenicity and health-related quality of life.

Conditions

Ovarian Neoplasms

Study of the Effect of Intravenous AVE0005 (VEGF Trap) in Advanced Ovarian Cancer Patients With Recurrent Symptomatic Malignant Ascites
Description

This study was designed to characterize the effect of aflibercept in participants with advanced chemoresistant ovarian cancer. Primary objective: Compare the effect of aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) to placebo treatment on repeat paracentesis in symptomatic malignant ascites in participants with advanced ovarian cancer Secondary objectives: Safety, tolerability, paracentesis-related parameters, participant-reported outcome.

Conditions

Ovarian Neoplasms, Ascites

Study of the Trifunctional Antibody Catumaxomab to Treat Recurrent Symptomatic Malignant Ascites
Description

The purpose of this study is to determine whether the investigational drug catumaxomab is a safe and effective treatment for recurrent symptomatic malignant ascites.

Conditions

Malignant Ascites

Mitomycin as a Hyperthermic Peritoneal Perfusion in Treating Patients With Malignant Ascites
Description

RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above normal body temperature. Peritoneal infusion of heated chemotherapy drugs, such as mitomycin, may kill more tumor cells. PURPOSE: This phase II trial is studying how well mitomycin works when given as a hyperthermic peritoneal perfusion in treating patients with malignant ascites.

Conditions

Metastatic Cancer

Octreotide in Treating Patients With Cancer-Related Malignant Ascites
Description

RATIONALE: Octreotide may be an effective treatment for malignant ascites. It is not yet known whether octreotide is more effective than a placebo in treating malignant ascites. PURPOSE: This randomized phase III trial is studying octreotide to see how well it works compared to placebo in treating patients with cancer-related malignant ascites.

Conditions

Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific

Tocilizumab Delivered Via Pleural and Peritoneal Catheters in Patients With Advanced Metastatic Cancer
Description

The purpose of this study to find out if tocilizumab can be safely infused into chest or abdominal cavities of patients with malignancy ascites (MA) or malignant pleural effusions (MPE). Patients will have a total of 4 doses, one dose administered each week. Each dose will be greater than the previous one.

Conditions

Malignant Pleural Effusion, Malignant Ascites

Metformin and Chemotherapy in Treating Patients With Stage III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Description

This randomized phase II trial studies how well metformin hydrochloride and combination chemotherapy works in treating patients with stage III-IV ovarian, fallopian tube, or primary peritoneal cancer. Drugs used in chemotherapy, such as carboplatin, paclitaxel and docetaxel, 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. Metformin hydrochloride may help carboplatin, paclitaxel and docetaxel work better by making tumor cells more sensitive to the drugs. Studying samples of blood and tissue in the laboratory from patients receiving metformin hydrochloride may help doctors learn more about the effects of metformin hydrochloride on cells. It may also help doctors understand how well patients respond to treatment. Giving metformin hydrochloride together with combination chemotherapy may kill more tumor cells.

Conditions

Brenner Tumor, Malignant Ascites, Malignant Pleural Effusion, Ovarian Clear Cell Cystadenocarcinoma, Ovarian Endometrioid Adenocarcinoma, Ovarian Mixed Epithelial Carcinoma, Ovarian Serous Cystadenocarcinoma, Ovarian Undifferentiated Adenocarcinoma, Recurrent Fallopian Tube Cancer, Recurrent Ovarian Epithelial Cancer, Recurrent Ovarian Germ Cell Tumor, Recurrent Primary Peritoneal Cavity Cancer, Stage IIIA Fallopian Tube Cancer, Stage IIIA Ovarian Epithelial Cancer, Stage IIIA Ovarian Germ Cell Tumor, Stage IIIA Primary Peritoneal Cavity Cancer, Stage IIIB Fallopian Tube Cancer, Stage IIIB Ovarian Epithelial Cancer, Stage IIIB Ovarian Germ Cell Tumor, Stage IIIB Primary Peritoneal Cavity Cancer, Stage IIIC Fallopian Tube Cancer, Stage IIIC Ovarian Epithelial Cancer, Stage IIIC Ovarian Germ Cell Tumor, Stage IIIC Primary Peritoneal Cavity Cancer, Stage IV Fallopian Tube Cancer, Stage IV Ovarian Epithelial Cancer, Stage IV Ovarian Germ Cell Tumor, Stage IV Primary Peritoneal Cavity Cancer

EF5 in Detecting Oxygen Level and Blood Vessels in Tumor Cells of Patients Undergoing Photodynamic Therapy for Intraperitoneal or Pleural Cancer
Description

This phase II trial is studying how well EF5 works in detecting oxygen level and blood vessels in tumor cells of patients who are undergoing photodynamic therapy for intraperitoneal or pleural cancer. Diagnostic procedures using EF5 to detect oxygen level and blood vessels in tumor cells may help to improve the way photodynamic therapy is given

Conditions

Advanced Malignant Mesothelioma, Localized Malignant Mesothelioma, Malignant Ascites, Primary Peritoneal Cavity Cancer, Recurrent Malignant Mesothelioma

Oxaliplatin With Or Without Floxuridine and Leucovorin in Treating Patients With Metastatic Cancer of the Peritoneum
Description

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of oxaliplatin with or without floxuridine and leucovorin in treating patients who have metastatic cancer of the peritoneum.

Conditions

Cancer

ILX-295501 in Treating Patients With Stage III or Stage IV Ovarian Cancer That Has Not Responded to Previous Treatment
Description

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of ILX-295501 in treating patients who have stage III or stage IV ovarian cancer that has not responded to previous therapy.

Conditions

Fallopian Tube Cancer, Metastatic Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

QOL and Sarcopenia in Patients With Ascites
Description

Clinical data regarding quality of life in patients with refractory ascites is limited and preceded the development of newer questionnaires that may be more robust. One primary objective of this study is to study changes in quality in life in a prospective fashion using newer general and ascites-specific quality of life survey instruments specific to benign and malignant etiologies. Sarcopenia is a condition that is prevalent in cancer and cirrhosis. Current data is retrospective and associative, evaluating heterogeneous patient populations at different stages within the timeline of refractory ascites. The other primary objective of this study is to study sarcopenia in a prospective fashion and to understand its kinetics once a patient develops refractory ascites. Prospectively-obtained measures of deterioration in patient-reported outcomes and in muscle mass will form the basis for the next stage of investigation of interventions to mitigate these declines.

Conditions

Ascites Hepatic, Ascites, Malignant

Mass Response of Tumor Cells As a Biomarker for Rapid Therapy Guidance (TraveraRTGx)
Description

The primary objective of this study, sponsored by Travera Inc. in Massachusetts, is to validate whether the mass response biomarker has potential to predict response of patients to specific therapies or therapeutic combinations using isolated tumor cells from various specimen formats including malignant fluids such as pleural effusions and ascites, core needle biopsies, fine needle aspirates, or resections.

Conditions

Pleural Effusion, Malignant, Ascites, Malignant, Carcinoma, Carcinoma, Hepatocellular, Carcinoma, Renal Cell, Carcinoma, Renal, Carcinoma, Small Cell, Carcinoma, Non-Small-Cell Lung, Carcinoma, Pancreatic Ductal, Carcinoma, Neuroendocrine, Carcinoma, Thymic, Carcinoma, Pancreatic, Carcinoma Breast, Carcinoma, Ovarian, Carcinoma Bladder, Carcinoma of Unknown Primary, Carcinoma of the Head and Neck, Carcinoma of the Oropharynx, Carcinoma of the Larynx, Carcinoma of the Bladder, Carcinoma of Esophagus, Carcinoma of the Nasopharynx, Carcinoma of the Penis, Carcinoma of the Cervix, Carcinoma of the Anus, Carcinoma of the Vulva, Carcinoma of the Appendix, Carcinoma of the Oral Cavity, Cholangiocarcinoma, Melanoma, Mesothelioma, Pancreatic Cancer