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NCT ID: NCT00612222 Terminated - Metastatic Melanoma Clinical Trials

Anti-MART-1 F5 Cells Plus ALVAC MART-1 Vaccine to Treat Advanced Melanoma

Start date: January 2008
Phase: Phase 2
Study type: Interventional

Background: - Melanoma antigen recognized by T-cells (MART)-1 is a protein present in melanoma cells. - An experimental procedure developed for treating patients with melanoma uses the anti-MART-1 F5 gene and a type of virus to make special cells called anti-MART-1 F5 cells that are designed to destroy the patient's tumor. These cells are created in the laboratory using the patient's own tumor cells or blood cells. - The treatment procedure also uses a vaccine called plaque purified canarypox vector (ALVAC) MART-1, made from a virus that ordinarily infects canaries and is modified to carry a copy of the MART-1 gene. The virus cannot reproduce in mammals, so it cannot cause disease in humans. When the vaccine is injected into a patient, it stimulates cells in the immune system that may increase the efficiency of the anti-MART-1 F5 cells. Objectives: -To evaluate the safety and effectiveness of anti-MART-1 F5 and the ALVAC vaccine in treating patients with advanced melanoma. Eligibility: -Patients 18 years of age with metastatic melanoma for whom standard treatments have not been effective. Design: - Patients undergo scans, x-rays and other tests and leukapheresis to obtain white cells for laboratory treatment. - Patients have 7 days of chemotherapy to prepare the immune system for receiving the anti-MART-1 F5. - Patients receive the ALVAC vaccine, anti-MART-1 F5 cells and interleukin-2 (IL-2) (an approved treatment for advanced melanoma). The anti-MART-1 F5 cells are given as an infusion through a vein. The vaccine is given as injections just before the infusion of anti-MART-1 F5 cells and again 2 weeks later. IL-2 is given as a 15-minute infusion every 8 hours for up to 5 days after the cell infusion for a maximum of 15 doses. - After hospital discharge, patients return to the clinic for periodic follow-up with a physical examination, review of treatment side effects, laboratory tests and scans every 1 to 6 months.

NCT ID: NCT00610311 Terminated - Metastatic Melanoma Clinical Trials

Anti-gp100 Cells Plus ALVAC gp100 Vaccine to Treat Advanced Melanoma

Start date: January 2008
Phase: Phase 2
Study type: Interventional

Background: - gp100 is a protein that is often found in melanoma tumors. - An experimental procedure developed for treating patients with melanoma uses anti-gp100 cells designed to destroy their tumors. The anti-gp100 cells are created in the laboratory using the patient's own tumor cells or blood cells. - The treatment procedure also uses a vaccine called plaque purified canarypox vector (ALVAC) gp100, made from a virus that ordinarily infects canaries and is modified to carry a copy of the gp100 gene. The virus cannot reproduce in mammals, so it cannot cause disease in humans. When the vaccine is injected into a patient, it stimulates cells in the immune system that may increase the efficiency of the anti gp 100 cells. Objectives: -To evaluate the safety and effectiveness of anti-gp100 cells and the ALVAC gp100 vaccine in treating patients with advanced melanoma. Eligibility: -Patients with metastatic melanoma for whom standard treatments have not been effective. Design: - Patients undergo scans, x-rays and other tests and leukapheresis to obtain white cells for laboratory treatment. - Patients have 7 days of chemotherapy to prepare the immune system for receiving the gp100 cells. - Patients receive the ALVAC vaccine, anti-gp100 cells and interleukin-2 (IL-2) (an approved treatment for advanced melanoma). The anti gp100 cells are given as an infusion through a vein. The vaccine is given as injections just before the infusion of gp100 cells and again 2 weeks later. IL-2 is given as a 15-minute infusion every 8 hours for up to 5 days after the cell infusion for a maximum of 15 doses. - After hospital discharge, patients return to the clinic for periodic follow-up with a physical examination, review of treatment side effects, laboratory tests and scans every 1 to 6 months.

NCT ID: NCT00509496 Terminated - Melanoma Clinical Trials

Phase II Study of Metastatic Melanoma With Lymphodepleting Conditioning and Anti-gp100:154-162 TCR Gene Engineered Lymphocytes

Start date: June 2007
Phase: Phase 2
Study type: Interventional

Background: - Human peripheral blood lymphocytes have been engineered to express a T-cell receptor (TCR) that recognizes a blood type, human leukocyte antigen (HLA-A*0201) derived from the gp100 protein. A retroviral vector was constructed that can deliver the TCR to cells. - This gene-engineered cell is over 10 times more reactive with melanoma cells than is the melanoma antigen recognized by T-cells (MART-1) TCR that resulted in tumor shrinkage for two patients with metastatic melanoma. Objectives: - To determine whether an anti-melanoma protein receptor can be put in cells removed from patients' tumors or blood and then reinfused, with the purpose of shrinking tumors. - To evaluate safety and effectiveness of the treatment. Eligibility: - Patients 18 years of age or older with metastatic cancer melanoma (cancer that has spread beyond the original site). - Patient's leukocyte antigen type is HLA-A*0201. Design: -Patients undergo the following procedures: - Leukapheresis (on two occasions). This is a method of collecting large numbers of white blood cells. The cells obtained in the first leukapheresis procedure are grown in the laboratory, and the anti-gp100 protein is inserted into the cells using an inactivated (harmless) virus in a process called retroviral transduction. Cells collected in the second leukapheresis procedure are used to evaluate the effectiveness of the study treatment. - Chemotherapy. Patients are given chemotherapy through a vein (intravenously, IV) over 1 hour for 2 days to suppress the immune system so that the patient's immune cells do not interfere with the treatment. - Treatment with anti-gp100. Patients receive an IV infusion of the treated cells containing anti-gp100 protein, followed by infusions of a drug called IL-2 (aldesleukin), which helps boost the effectiveness of the treated white cells. - Patients are given support medications to prevent complications such as infections. - Patients may undergo a tumor biopsy (removal of a small piece of tumor tissue). - Patients are evaluated with laboratory tests and imaging tests, such as CT scans, 4 to 6 weeks after treatment and then once a month for 3 to 4 months to determine the response to treatment. - Patients have blood tests at 3, 6, and 12 months and then annually for 5 years.

NCT ID: NCT00278018 Terminated - Solid Tumors Clinical Trials

Peritumoral Injection of Immature Dendritic Cells to Irradiated Skin Metastases of Solid Tumors

Start date: December 2005
Phase: Phase 1/Phase 2
Study type: Interventional

Melanoma is the main cause of death in patients with skin cancer. Once it has metastasized, this cancer has been shown to respond to chemotherapy only in rare cases. Immunotherapy represents an approach to treatment based on the immune response to cancer antigens. The long-term objective of this study is to develop a therapeutic approach for the treatment of cancer in general, and melanoma in particular, based on immunotherapy, using a combination of local tumor irradiation followed by injection of immature dendritic cells (iDC).The treatment will be followed by the injection of interferon alpha, which we expect will induce activation of the iDC. This trial is based on the hypothesis that local radiation, which causes destruction of the tumor, in combination with injection of the patient's own iDC and the activation of these cells with interferon alpha, will induce an effective immune response against the tumor. In order to test the suggested approach, we propose a 20-patients clinical trial that will evaluate the objective clinical and immunological response to the proposed treatment in patients with malignant melanoma and other solid tumors.

NCT ID: NCT00023790 Terminated - Breast Cancer Clinical Trials

Photodynamic Therapy in Treating Patients With Skin Cancer or Solid Tumors Metastatic to the Skin

Start date: August 2001
Phase: Phase 1
Study type: Interventional

RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. This may be effective treatment for skin cancer and cancer that is metastatic to the skin. PURPOSE: Phase I trial to study the effectiveness of photodynamic therapy in treating patients who have either squamous cell or basal cell carcinoma of the skin or solid tumors metastatic to the skin.

NCT ID: NCT00005097 Terminated - Clinical trials for Non-melanomatous Skin Cancer

Green Tea Extract in Treating Patients With Actinic Keratosis

Start date: August 1999
Phase: Phase 2
Study type: Interventional

RATIONALE: Green tea extract contains ingredients that may inhibit the growth of actinic keratosis. PURPOSE: Randomized phase II trial to determine the effectiveness of green tea extract in treating patients who have actinic keratosis.

NCT ID: NCT00002947 Terminated - Lung Cancer Clinical Trials

Indium In 111 Pentetreotide in Treating Patients With Refractory Cancer

Start date: October 1996
Phase: Phase 1
Study type: Interventional

RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells. Giving radiation therapy in different ways may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of indium In 111 pentetreotide in treating patients who have refractory cancer.