Active clinical trials for "Neoplasm Metastasis"

Oxaliplatin is an experimental anti-cancer drug that can shrink tumors such as colon cancer. However, because this drug can damage the kidneys, it is necessary to determine what doses of the drug can safely be given to patients with poor kidney function. Patients with advanced cancer, poorly functioning kidneys, and no good standard treatment options are eligible for this study. Candidates will be screened with imaging tests, such as CT and MRI scans, to determine the size and location of the cancer and with blood and urine tests to evaluate kidney and liver function. Study participants will receive oxaliplatin intravenously (through a vein) every 3 weeks for as long as the cancer is under control and there are no serious side effects from the drug. If significant side effects develop, the dosage will be reduced, or the drug will be stopped. Blood tests to measure blood cell counts will be done at least once a week, and CT scans, chest X-rays, and MRIs will be done about once every 6 weeks to assess the tumor's response to the treatment. Additional blood tests will be done at the beginning of the first two treatment cycles to measure the amount of oxaliplatin in the blood, and urine will be collected during the first 24 hours of drug treatment to determine how much drug is eliminated by the body in urine.

This study examines the feasibility of using gene therapy to prevent some of the toxicities of an intensive chemotherapy regimen in patients with metastatic breast cancer. Patients who do not wish to participate in the gene therapy procedures will be offered identical chemotherapy on a different protocol. Patients will be treated initially with chemotherapy which is active against breast cancer, but which has a low potential to hurt blood-forming cells. Then, the patient will receive high dose chemotherapy, during which time blood cells which are capable of rebuilding patients' bone marrows will be removed from the patients' bloodstream. We will use these blood cell collections to isolate peripheral blood progenitor cells (PBPCs), those cells which are thought to be the forbears of all other blood cells. A portion of the PBPCs will be exposed to a disabled virus which either carries genetic material referred to as the multidrug resistance gene (MDR1). The virus will transfer the MDR1 gene into a portion of the patient's PBPCs. The purpose of putting the MDR1 gene into the patients' PBPCs is to try to make these blood cells and their offspring resistant to the toxic effects of certain types of breast cancer chemotherapy. The MDR1 protein (Pgp) that is made from the MDR1 gene makes cells resistant to chemotherapy in laboratory systems by pumping the drug out of cells before the drug is able to kill the cell. Another portion of the patients PBPCs will be exposed to a similar disabled virus carrying a different gene called the NeoR gene. The NeoR gene should not change the effects of chemotherapy on blood forming cells. The purpose of using the NeoR gene is that it will serve as a point of comparison, to see if the presence of the MDR1 drug resistance gene really helps blood forming cells withstand subsequent chemotherapy. Patients are then treated with a very high dose of another anti-breast cancer drug, one that is very toxic to bone marrow cells, and patients will then receive the frozen PBPCs, which contain the new genes, to help them recover from the chemotherapy. After recovery, patients will then be treated with high doses of paclitaxel (Taxol) and doxorubicin (Adriamycin) chemotherapy. Both of these drugs are very active against breast cancer, and the MDR1 gene may potentially protect bone marrow cells against these drugs. Samples of peripheral blood cells will be obtained before each of these doses of chemotherapy to determine whether the number of blood cells that contain the MDR1 gene in comparison to the number that contain the NeoR gene has increased in response to the chemotherapy.

Bolus PSC 833 is administered on Day 1 simultaneously with initiation of 24 hour continuous infusion of PSC 833, followed by another continuous infusion lasting an additional 6 days. To ensure the safety of a 7 day infusion of PSC 833, one patient is treated for 5 days and a second for 6 days, before the first cohort is enrolled. Vinblastine is administered in escalating doses on days 2-5. At least 3 patients are entered at each dose level. The MTD will be defined as the dose immediately below that at which 2 patients experience dose limiting toxicity. Treatment continues every 28 days.

This is a phase I/II study of interleukin-1, G-CSF and high dose ICE chemotherapy with autologous bone marrow transplant in patients with relapsed breast, testicular and lymphoid cancers. The initial goal of this study was to define the toxicity of interleukin-1 administered for 7 days prior to ICE chemotherapy. A total of 22 patients have been treated with IL-1 and ICE and results showed a more rapid engraftment (4.5 days) with IL-1. A second cohort of 18 patients also received G-CSF and engraftment was further shortened in some subgroups. Overall, the median time to engraftment was 16 days with both IL-1 and G-CSF. Accrual will continue to further define the toxicity and efficacy of this regimen.

The clinical study entitled "A Phase I Study of Infusional Chemotherapy with the P-glycoprotein Antagonist PSC 833" seeks to determine the maximum tolerated dose for a proposed P-glycoprotein antagonist, PSC 833. PSC 833 is a cyclosporine analogue which is purportedly non-nephrotoxic and non-immunosuppressive. It has been shown in in-vitro studies to enhance chemosensitivity as well as cyclosporine and to be far better at increasing intracellular drug accumulation than the concentrations of verapamil which are clinically achievable. The purpose of this study is to define the maximum tolerated dose in combination with vinblastine, and to determine how the drug affects the pharmacokinetics of vinblastine. PSC 833 will most likely reduce the clearance of vinblastine, as reported for the parent compound, cyclosporine. This effect will increase the area under the curve (AUC) of vinblastine, may increase toxicity, and requires that the escalation scheme for PSC 833 be a conservative one. Initially, a 120 hour infusion of vinblastine will be given alone. Then 8 days of PSC 833 will follow to allow monitoring of adverse effects of PSC 833 alone. This first cycle of vinblastine will be given in the absence of PSC 833; in second and subsequent cycles both agents will be combined. Escalation of the PSC 833 will continue until a target concentration is reached, or until the maximum tolerated dose is reached. Clinical responses will be monitored in order to provide the best possible medical care to our patients.

Patients with Zollinger-Ellison Syndrome suffer from ulcers of the upper gastrointestinal tract, higher than normal levels of gastric acid, and tumors of the pancreas known as non-beta islet cell tumors. Prior to the use of drugs to cure the ulcers, patients typically died due to severe ulcers. Because of such effective drugs to treat the ulcers it is more common to see patients dying due to the pancreatic tumors. The study will observe patients suffering from Zollinger-Ellison Syndrome and non-beta islet cell tumors and determine the effectiveness of combined chemotherapy with streptozotocin, 5-fluorouracil, and doxorubicin.

Physical activity (PA) has been an integral part of non-drug therapy since the early 2010s. This supportive care is likely to reduce fatigue and improve the quality of life of patients during and after the cancer treatment phase. Physical activity also has a protective effect in terms of tertiary prevention by reducing the risk of recurrence of certain cancers (breast, colon, prostate) by around 40 to 50% and by reducing overall mortality. Adapted physical activity (APA) is offered at the Institut de Cancérologie de l'Ouest (ICO) in Angers, but there are obstacles particularly linked to the geographical distance of the establishment where this activity is offered. The RAPASS project is a prospective study which will be proposed to patients followed at the ICO, living in rural areas and far from Angers. Its main objective is to describe the fatigue and quality of life of patients before, during and after a 13-session home-based APA programme. The data collected will also be used to describe changes in physical condition and level, compliance with the programme, continuation of physical activity beyond the duration of the programme, and satisfaction.

The aim of this project is to assess the rate of recovery of secondary hypothyroidism in patients with pituitary disorders.

This is a non-randomized observational trial designed to collect detailed clinical, social determinant, and genomic data from patients enrolled in molecular oncology tumor boards across four comprehensive cancer centers.

The prognosis of peritoneal metastases from colorectal cancer has recently improved with cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC). Although outcomes are further improved when early stage peritoneal metastases are treated, adjuvant HIPEC has not yet been thoroughly addressed. This prospective pilot study assessed feasibility, safety and efficacy of HIPEC performed simultaneously with primary curative surgery in colorectal cancer patients with primary tumor-related risk-factors for the development of metachronous peritoneal metastases.