Active clinical trials for "Neoplasm Metastasis"

This phase I multicenter feasibility trial is studying the safety and potential efficacy of infusing ex vivo expanded cord blood progenitors with one unmanipulated umbilical cord blood unit for transplantation following conditioning with fludarabine, cyclophosphamide and total body irradiation (TBI), and immunosuppression with cyclosporine and mycophenolate mofetil (MMF) for patients with hematologic malignancies. Chemotherapy, such as fludarabine and cyclophosphamide, and TBI given before an umbilical cord blood transplant stops the growth of leukemia cells and works to prevent the patient's immune system from rejecting the donor's stem cells. The healthy stem cells from the donor's umbilical cord blood help the patient's bone marrow make new red blood cells, white blood cells, and platelets. It may take several weeks for these new blood cells to grow. During that period of time, patients are at increased risk for bleeding and infection. Faster recovery of white blood cells may decrease the number and severity of infections. Studies have shown that counts are more likely to recover more quickly if increased numbers of cord blood cells are given with the transplant. We have developed a way of growing or "expanding" the number of cord blood cells in the lab so that there are more cells available for transplant. We are doing this study to find out whether or not giving these expanded cells along with one unexpanded cord blood unit is safe and if use of expanded cells can decrease the time it takes for white blood cells to recover after transplant. We will study the time it takes for blood counts to recover, which of the two cord blood units makes up the patient's new blood system, and how quickly immune system cells return

This study is to investigate the safety of NS-9 and to see how well it is tolerated in patients with cancer that has metastasized (spread) to the liver from another primary tumor. NS-9 is a drug developed to go to the liver to cause cell death specifically in tumor cells. This study is also set up to determine the best dose to use.

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of VNP40101M in treating patients who have advanced or metastatic cancer.

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with cetuximab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with cetuximab works in treating patients with unresectable liver metastases from colorectal cancer.

This phase II, 43 patient trial, will evaluate the efficacy of GTI-2040, an antisense oligonucleotide complementary to the R2 component of ribonucleotide reductase (RNR) mRNA, in combination with capecitabine, in the setting of advanced/metastatic renal cell carcinoma. Preclinical studies have shown synergy between GTI-2040 and capecitabine against renal cell carcinoma.

The purpose of this study is to determine if using intensity modulated radiation therapy for brain metastases is safe and will improve local control more than standard whole brain radiation therapy.

This study will evaluate the safety and effects of vaccine treatment plus radiation to the liver in patients with solid tumors that have spread to the liver. The vaccine treatment consists of three parts: 1) a "priming vaccine" called rV-CEA(6D)-TRICOM, made from vaccinia virus; 2) a "boosting vaccine" called rF-CEA(6D)-TRICOM), made from fowlpox virus; and 3) a fowlpox virus injected with DNA for GM-CSF, a chemical that boosts the immune system, called rF-GM-CSF. Human DNA is inserted into the priming and boosting vaccine viruses to cause production of proteins that enhance immune activity and also to produce carcinoembryonic antigen (CEA) - a protein that is normally produced by the patient's tumor cells. The study also uses radiation, because laboratory and animal studies show that low doses of radiation to tumors that produce CEA make the tumor more sensitive to the effects of the vaccines. Patients 18 years of age and older who have a solid tumor that has spread to the liver may be eligible for this study. Candidates must have had at least one course of chemotherapy for metastatic disease and their tumor must produce CEA. Candidates are screened with a medical history and physical examination; blood and urine tests, test of pathology slides from surgery to determine the presence of the CEA marker, imaging studies to assess the extent of tumor, and an electrocardiogram (and cardiologic evaluation, if clinically indicated). Participants receive the priming vaccination on study day 1. After 3 weeks and then again every 2 weeks for 2 months (study days 21, 35, 49 and 63), they receive a boosting vaccine. All vaccines are injected under the skin. With every vaccination they also receive an injection of rF-GM-CSF to increase the number of immune cells at the vaccination site. The day after each of the first four boosting vaccinations, patients undergo 4 consecutive days of radiation to the tumor in the liver (study days 22-25, 36-39, 50-53 and 64-67). Patients may continue treatment with monthly booster vaccinations (without further radiation therapy) as long as their cancer does not get worse and they do not develop serious treatment side effects. Patients are monitored for safety and treatment response with the following tests and procedures: Blood and urine tests and clinic visits every 2 to 4 weeks to monitor liver, kidney, and other organ function. Imaging studies to assess the tumor around study day 91 and every 2 months after that while on the study. Apheresis (a procedure for collecting immune cells called lymphocytes) - Apheresis is done before the first vaccination on study day 1 and again around study day 91. For this procedure, blood is collected through a needle in an arm vein. The blood circulates through a machine that separates it into its components by spinning, and the lymphocytes are extracted. The rest of the blood is returned to the patient through the same needle. The collected lymphocytes are studied to measure the immune response to treatment. Liver biopsy (optional) - This test is done once before starting radiation treatment and again around 3 to 7 days after completing the first dose of radiation. The biopsy provides information on the type of cancer, the level of CEA produced by the tumor, and the immune status of the tumor. For this procedure, the skin over the liver is numbed with an anesthetic, a needle is placed in the liver tumor, and a small sample of tumor is withdrawn through the needle. After treatment is completed, patients are monitored for up to 15 years, including yearly medical histories and physical examinations for 5 years following their last vaccination. Information beyond 5 years is collected once a year by telephone

Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth. This phase II trial is studying how well lapatinib works in treating brain metastases in patients with stage IV breast cancer and brain metastases.

Rationale: Overexpression of epidermal growth factor receptor (EGFR) has been observed in kidney, prostate, colon, lung, breast, and other cancers, and is often associated with a poor prognosis. TGFa and EGF, the ligands for EGFR, are also overexpressed in some of these tumor types, suggesting a self-propagating stimulus that may be responsible for rapid tumor growth. Blocking this stimulus by blocking activation of EGFR with ABX-EGF, a fully human monoclonal antibody against EGFR, may prevent tumor growth and perhaps shrink tumors. Purpose: This is a Phase 2 clinical trial to evaluate the safety and efficacy of ABX-EGF in the treatment of advanced NSCLC following failure of paclitaxel and carboplatin therapy on treatment arm 1 of Immunex Protocol 054.0004 (Amgen Protocol 20025404), Part 2.

The purpose of this study is to test a novel dendritic cell (DC) vaccine in patients with Stage IV melanoma.