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Neoplasms, Second Primary clinical trials

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NCT ID: NCT01457131 Terminated - Metastatic Cancer Clinical Trials

Modified White Blood Cells That Secrete IL-2 and Express a Protein That Targets the ESO-1tumor Protein for Metastatic Cancer

Start date: October 6, 2011
Phase: Phase 1
Study type: Interventional

Background: - A new cancer treatment involves collecting white blood cells from an individual, modifying them to secrete IL-2 and target the ESO-1 protein expressed on some cancers, and returning them to the body. The cells may then be able to seek out the cancer cells and destroy them. Some kinds of cancer contain a protein called ESO-1, which is found on the surface of the cells. Doctors want to modify white blood cells to have an anti-ESO-1 effect, and use them to treat the cancer that has the ESO-1. In addition to adding genes that target the ESO-1 protein to the cells, the genes for IL-12 are added to the cells. IL-12 is a protein that stimulates the immune system. This type of therapy is called gene transfer. Objectives: - To test the safety and effectiveness of anti-ESO-1/IL-12 white blood cells against metastatic cancer. Eligibility: - Individuals at least 18 years of age who have metastatic cancer that expresses ESO-1 and has not responded to standard treatments. Design: - Participants will be screened with a medical history and physical exam. They will also have blood tests and imaging studies. - Participants will have leukapheresis about a month before the treatment to collect white blood cells. - They will have chemotherapy 5 days before the treatment to suppress the immune system, and prepare the body for the anti-ESO-1/IL-12 cells. - The anti-ESO-1/IL-12 cells will be given as an infusion. - Participants will be monitored in the hospital during their recovery from the treatment. - Participants will have regular followup exams every 1 to 6 months. The exams will include blood tests, imaging studies, and other studies. Due to toxicities seen with the regimen, it was decided not to pursue the phase 2 portion of the study.

NCT ID: NCT01441115 Terminated - Cancer Clinical Trials

ECI301 and Radiation for Advanced or Metastatic Cancer

Start date: September 6, 2011
Phase: Phase 1
Study type: Interventional

Background: - ECI301 is a drug that may help make cancer cells more visible to the immune system after radiation. The drug may also help the immune system destroy the cancer at sites that have not received radiation therapy. Researchers want to study ECI301 in people with advanced cancer or cancer that has spread in the body (metastatic). Objectives: - To test ECI301 with radiation therapy for advanced or metastatic cancer. Eligibility: - People at least 18 years of age with either metastatic or advanced cancer that may benefit from radiation therapy. Design: - Participants will be screened with a medical history and physical exam. They will also have blood and urine tests, and imaging studies. - All participants will have radiation therapy 5 days a week for 2 weeks. - They will have different doses of ECI301 to test its safety and effectiveness. ECI301 will be given in a vein during the second week of radiation therapy. Frequent blood tests and imaging studies will monitor the treatment. - After participants have ECI301, tumor samples may be taken from the site that had radiation and another site that did not have radiation. - Follow-up visits will include blood tests and imaging studies.

NCT ID: NCT01322100 Terminated - Brain Metastases Clinical Trials

Electrochemotherapy as a Palliative Treatment for Brain Metastases

Start date: April 2011
Phase: Phase 1
Study type: Interventional

Because electrochemotherapy is a quick and effective treatment for cutaneous metastases, a novel electrode device has been developed for treatment in soft tissue such as the brain. Up to 18 patients will be treated in this phase I dose-escalating study of electrochemotherapy for brain metastases. Primary endpoint of the clinical trial is safety and secondary endpoint is efficacy. One brain metastasis is treated once-only with the electrode device guided stereotactically through a burr hole using CT monitoring. The patient will be fully anesthetized during the treatment procedure. Patients are followed up for 6 months with regard to neurological function, Barthel Index, steroid use and adverse effects registration (CTCAE). Tumor response will be evaluated by Magnetic Resonance imaging (MRI).

NCT ID: NCT01273181 Terminated - Metastatic Cancer Clinical Trials

MAGE-A3/12 Metastatic Cancer Treatment With Anti-MAGE-A3/12 TCR-Gene Engineered Lymphocytes

Start date: December 2010
Phase: Phase 1/Phase 2
Study type: Interventional

Background: - MAGE-A3/12 is a type of protein commonly found on certain types of cancer cells, particularly in metastatic cancer. Researchers have developed a process to take lymphocytes (white blood cells) from cancer patients, modify them in the laboratory to target cancer cells that contain MAGE-A3/12, and return them to the patient to help attack and kill the cancer cells. These modified white blood cells are an experimental treatment, but researchers are interested in determining their safety and effectiveness as a possible treatment for cancers that involve MAGE-A3/12. Objectives: - To evaluate the safety and effectiveness of anti-MAGE-A3/12 lymphocytes as a treatment for metastatic cancers that have not responded to standard treatment. Eligibility: - Individuals at least 18 years of age who have been diagnosed with metastatic melanoma, renal cell cancer, or another type of metastatic cancer that has not responded to standard treatment. Design: - Participants will be screened with a full medical history and physical examination, as well as blood and urine tests, tumor samples, and imaging studies. - Participants will have leukapheresis to collect enough white blood cells for modification in the laboratory. - Seven days before the start of anti-MAGE-A3/12 treatment, participants will have chemotherapy with cyclophosphamide and fludarabine to suppress the immune system in preparation for the treatment. - After the last dose of chemotherapy, participants will receive the anti-MAGE-A3/12 cells as an infusion for 20 to 30 minutes, followed by a dose of interleukin-2 to keep the anti-MAGE-A3/12 cells alive and active as long as possible. Participants will also receive filgrastim to encourage the production of blood cells. - Participants will remain in the hospital to be monitored for possible side effects, and after release from the hospital will have regular followup exams with blood samples and imaging studies to evaluate the effectiveness of the treatment....

NCT ID: NCT01240642 Terminated - Clinical trials for Metastatic Cancer With Normal Renal Function

An Open-label, Dose Escalation Multi-center Study in Patients With Advanced Cancer to Determine the Infusion Rate Effect of ASA 404 With Paclitaxel Plus Carboplatin Regimen or Docetaxel on the Pharmacokietics of Free and Total ASA404

Start date: January 2010
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the effect of the ASA404 infusion rate and co-administrating ASA404 with paclitaxel + carbopaltin chemotherapy regimen or docetaxel on the pharamcokinetics (PK) of free and total ASA404.

NCT ID: NCT01218867 Terminated - Metastatic Cancer Clinical Trials

CAR T Cell Receptor Immunotherapy Targeting VEGFR2 for Patients With Metastatic Cancer

Start date: November 10, 2010
Phase: Phase 1/Phase 2
Study type: Interventional

Background: The National Cancer Institute (NCI) Surgery Branch has developed an experimental therapy for treating patients metastatic cancer that involves taking white blood cells from the patient, growing them in the laboratory in large numbers, genetically modifying these specific cells with a type of virus (retrovirus) to attack only the tumor cells, and then giving the cells back to the patient. This type of therapy is called gene transfer. In this protocol, we are modifying the patient s white blood cells with a retrovirus that has the gene for anti-vascular endothelial growth factor receptor (VEGFR2) incorporated in the retrovirus. Objectives: - To determine a safe number of these cells to infuse and to see the safety and effectiveness of cell therapy using anti-VEGFR2 gene modified tumor white blood cells to treat recurrent or relapsed cancer. Eligibility: - Individuals greater than or equal to 18 years of age and less than or equal to 70 years of age who have been diagnosed with metastatic cancer that has not responded to or has relapsed after standard treatment. Design: - Work up stage: Patients will be seen as an outpatient at the National Institutes of Health (NIH) clinical Center and undergo a history and physical examination, scans, x-rays, lab tests, and other tests as needed - Leukapheresis: If the patients meet all of the requirements for the study they will undergo leukapheresis to obtain white blood cells to make the anti-VEGFR2 cells. {Leukapheresis is a common procedure which removes only the white blood cells from the patient.} - Treatment: Once their cells have grown the patients will be admitted to the hospital for the conditioning chemotherapy, the anti-VEGFR2 cells and aldesleukin. They will stay in the hospital for about4 weeks for the treatment. - Follow up: Patients will return to the clinic for a physical exam, review of side effects, lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1 year as long as their tumors are shrinking. Follow up visits will take up to 2 days.

NCT ID: NCT00949052 Terminated - Cancer Clinical Trials

Genetic Susceptibility and Risk of Second Cancers in Patients Who Have Undergone Stem Cell Transplant for Cancer

Start date: January 2009
Phase:
Study type: Observational [Patient Registry]

RATIONALE: Identifying genes that increase a person's susceptibility to second cancers may help the study of cancer treatment. PURPOSE: This study is looking at genetic susceptibility and risk of second cancers in patients who have undergone stem cell transplant for cancer.

NCT ID: NCT00924287 Terminated - Metastatic Cancer Clinical Trials

Gene Therapy Using Anti-Her-2 Cells to Treat Metastatic Cancer

Start date: November 2008
Phase: Phase 1/Phase 2
Study type: Interventional

Background: - Human epidermal growth factor receptor-2 (Her-2) is a gene found in both normal cells and cancer cells. Extra copies of the gene (overexpression) can cause too many Her-2 proteins (receptors) to appear on the cell surface and cause tumors to grow. - An experimental procedure developed for treating patients with cancer uses blood cells found in their tumors or bloodstream. The cells are genetically modified using the anti-Her-2 gene and a type of virus. The modified cells (anti-Her-2 cells) are grown in the laboratory and then given back to the patient to try to decrease the size of the tumors. This is called gene therapy. Objectives: - To determine whether advanced cancers that overexpress Her-2 can be treated effectively with lymphocytes (white blood cells) that have been genetically engineered to contain an anti-Her-2 protein. Eligibility: - Patients 18 years of age and older with metastatic cancer (cancer that has spread beyond the original site) and for whom standard treatments are not effective. - Patient's tumor overexpresses Her-2. Design: - Workup with scans, x-rays and other tests. - Leukapheresis to obtain cells for preparing the anti-Her-2 cells for later infusion. - 1 week of chemotherapy to prepare the immune system for receiving the anti-Her-2 cells. - Infusion of anti-Her-2 cells, followed by interleukin-2 (IL-2) treatment. The cells are given as an infusion through a vein. IL-2 is given as a 15-minute infusion through a vein every 8 hours for a maximum of 15 doses. - Periodic follow-up clinic visits after hospital discharge for physical examination, review of treatment side effects, laboratory tests and scans every 1 to 6 months.

NCT ID: NCT00923806 Terminated - Metastatic Cancer Clinical Trials

Gene Therapy Using Anti-CEA Cells to Treat Metastatic Cancer

Start date: December 2008
Phase: Phase 1
Study type: Interventional

Background: - Carcinoembryonic antigen (CEA) is a protein present mostly in cancer cells. - An experimental procedure developed for treating patients with cancer uses blood cells found in their tumors or bloodstream. These cells are genetically modified using the anti-CEA gene and a type of virus. The modified cells (anti-CEA cells) are grown in the laboratory and then given back to the patient to try to decrease the size of the tumors. This is called gene therapy. Objectives: - To determine whether advanced cancers that that express the CEA antigen can be treated effectively with lymphocytes (white blood cells) that have been genetically engineered to contain an anti-CEA protein. Eligibility: - Patients 18 years of age and older with metastatic cancer (cancer that has spread beyond the original site) and for whom standard treatments are not effective. - Patients' tumors express the CEA antigen. - Patients have the human leukocyte (HLA-A*0201) antigen. Design: - Workup with scans, x-rays and other tests. - Leukapheresis to obtain cells for preparing the anti-CEA cells for later infusion. - 1 week of chemotherapy to prepare the immune system for receiving the anti-CEA cells. - Infusion of anti-CEA cells, followed by interleukin-2 (IL-2) treatment. The cells are given as an infusion through a vein. IL-2 is given as a 15-minute infusion through a vein every 8 hours for a maximum of 15 doses. - 1-2 weeks of recovery from the effects of chemotherapy and IL-2. - Periodic follow-up clinic visits after hospital discharge for physical examination, review of treatment side effects, laboratory tests and scans every 1 to 6 months.

NCT ID: NCT00855634 Terminated - Pancreatic Cancer Clinical Trials

Resection in Pancreatic Cancer With Minimal Metastatic Disease or Venous Infiltration Trial at Technische Universität München

PaMeViTUM
Start date: August 2009
Phase: N/A
Study type: Interventional

PaMeViTUM is a mono-centric prospective randomized controlled trial that compares different operating procedures in patients with pancreatic cancer and minimal metastatic disease or venous infiltration.