View clinical trials related to Carcinoma, Merkel Cell.
Filter by:This is a multicenter, international, single-arm, open-label, Phase 2 trial to evaluate the efficacy and safety of avelumab in participants with metastatic Merkel cell carcinoma (MCC).
There is no standard treatment for Merkel cell carcinoma(MCC), as no randomized trials have been conducted to establish standard of care. Despite a sizable number of objective responses induced by combination cyototoxic chemotherapy, a prolongation of patients overall survival has never been demonstrated. This open-label, randomized, double-arm, multi-centre, phase II study of F16IL2 in combination with paclitaxel versus paclitaxel monotherapy, proposes to test the therapeutic efficacy of F16IL2 plus paclitaxel in patients with metastatic Merkel cell carcinoma, who are not amenable to surgery. A total of 90 patients with Merkel cell carcinoma will be enrolled and treated during the study; 45 patients will receive the combination treatment of F16IL2 and paclitaxel (Arm A), and 45 patients will receive paclitaxel monotherapy (Arm B).
This is an open-label, non-randomized, phase 2 study to assess the feasibility of using cabozantinib in recurrent/metastatic Merkel Cell Carcinoma patients that progressed after platinum-based therapy.
This is a single arm, open-label, single center study evaluating the safety, feasibility, clinical efficacy and immunogenicity of GLA-SE administration to patients with Merkel cell carcinoma. Ten patients will be treated. The goal is for GLA-SE to assist the patient's own immune system in attacking the cancer cells.
Background: - Ipilimumab is a drug used to treat melanoma that cannot be treated surgically. It targets a molecule found on T-cells in the human immune system. Blocking these molecules on the T-cells might allow the cells to help destroy melanoma cells more effectively. This drug has also been studied in other cancers such as prostate cancer and lung cancer, but not yet in Merkel cell carcinoma (MCC). Researchers think therapy like ipilimumab that enhances the immune system may be effective against MCC. They want to study how safe the drug is and its effect on the immune system and tumors. Objectives: - To determine the number of subjects with MCC who take the study drug that remain alive 12 months later. Eligibility: - Adults 18 years and older who have metastatic MCC. Design: - Participants will be screened with a medical history and physical exam. - Participants will receive the study drug 4 times, one dose every 21 days. After the 4 visits, participants will receive a maintenance dose of the drug every 12 weeks until the drug is no longer beneficial. - They will receive the drug through a plastic tube usually inserted in a vein on the arm. - It will take 90 minutes to give each dose. - At all visits, participants will be screened with a medical history, physical exam, and blood tests. Any tumors on their skin will be measured and photographed. - Every 12 weeks during the study and maintenance period, participants will have a CT scan. Throughout the study and maintenance period, they will have blood and skin tests.
This phase I/II trial studies the side effects and best way to give laboratory treated autologous T cells together with aldesleukin and to see how well it works in treating patients with merkel cell carcinoma that has spread from the primary site (place where it started) to other places in the body. Biological therapies, such as cellular adoptive immunotherapy, may stimulate the immune system in different ways and stop tumor cells from growing. Aldesleukin may stimulate the white blood cells to kill tumor cells. Giving cellular adoptive immunotherapy with aldesleukin may be a better treatment for metastatic merkel cell carcinoma.
This study will evaluate the preliminary safety, pharmacokinetics, and anti-tumor activity of pasireotide s.c. in patients with metastatic melanoma or metastatic Merkel cell carcinoma. The study consists of three phases: screening, intra-patient dose-escalation, and follow-up phases. In the screening phase patient will be informed of all aspects of the study and sign informed consent forms and then be screened for study eligibility. During the intra-patient dose escalation phase, 18 patients will be treated with pasireotide s.c. 300 μg t.i.d. for 2 weeks. If there are no unacceptable AEs, defined as drug-related clinically meaningful, uncontrolled grade 3 or any grade 4 toxicities, patients will be dose escalated to 600 μg t.i.d. for 2 more weeks, then 900 μg t.i.d. for 2 weeks and then 1200 μg for 2 weeks provided that there are no unacceptable AEs. Each patient will be in the dose escalation phase for a maximum of 8 weeks. At end of the intra-patient dose escalation phase, patients will be allowed to switch to 80 mg pasireotide LAR i.m. q 28 d (or a lower dose in case of toxicity) for an additional 6 months or until disease progression, or unacceptable AEs, or patient withdraws consent. In addition, all patients will keep their pasireotide s.c. t.i.d. treatment (same dose as that at the end of the 8-week dose escalation phase) during the first 2 weeks of the LAR follow-up phase, except on the day receiving the first LAR dose because of an anticipated initial burst of drug release.
Patients with melanoma, some other rare skin cancers, and some cancers of the penis and scrotum can have their cancer spread to the lymph nodes in the upper part of the leg, called the groin. Medically, this area is called the inguinal area. At present, for melanomas and skin cancers this type of spread is usually found with a special test called a "sentinel lymph node biopsy". This procedure can find spread of even a few cells in a single lymph node—allowing the treating doctor to find the spread very early. Treatment for patients with skin cancer in the lymph nodes in this area is to remove all of the lymph nodes in this area. In patients with cancers of the penis and scrotum who do hot have any evidence of cancer having spread either by physical examination or by radiology tests, the lymph nodes in this area are removed to check and see if there is cancer in them. This is called staging. At present, the standard way to remove all of the lymph nodes in the groin is by a large incision, approximately 8-10 inches in length. For patients who have this operation, there is a very high incidence of infection after surgery: as many as 50% as patients can have a problem after surgery. These infections range from a low grade skin infection needing oral antibiotics to deep infections requiring the wound to be opened and occasionally needing readmission to the hospital and antibiotics given via the vein. With the advent of new technology and new equipment, the ability to perform this procedure through small incisions away from the groin and further down the leg has become possible. This procedure has never been performed routinely nor compared side by side to the standard open approach. The investigators propose to perform this protocol in two phases. The investigators have performed procedures in 20 groins to this point and have confirmed the number of lymph nodes and visually verified that the procedure is identical to the open procedure. The investigators performed these procedures in order to insure that the investigators were offering an equivalent option regardless of which procedure the patient is randomized to. The study will involve the randomization of patients undergoing the procedure. The investigators will randomize the next 110 patients in a 2:1 fashion (two people will get the videoscopic procedure for every one who gets the open procedure) until 73 patients are included in the video arm and 37 in the open arm. Outcomes including recurrence rate, duration of drain requirements, and incidence of lymphedema will be followed. Patients will be followed using standard of care processes, including regular office visits, physical exams, and radiographic imaging, when indicated. Patients will be followed for 5 years.
This phase II trial studies the effectiveness of ImmunoPulse IL-12® in treating patients with Merkel cell cancer. ImmunoPulse IL-12® is the combination of intratumoral interleukin-12 gene (also known as tavokinogene telseplasmid [tavo]) and in vivo electroporation-mediated plasmid deoxyribonucleic acid [DNA] vaccine therapy (tavo-EP) administered using the OncoSec Medical System (OMS). Placing the gene for interleukin-12 into Merkel cells may help the mount an effective anti-tumor immune response to kill tumor cells.
This phase I trial studies the side effects and best dose of cixutumumab when given together with everolimus and octreotide acetate in treating patients with advanced low- or intermediate-grade neuroendocrine cancer. Monoclonal antibodies, such as cixutumumab, may find tumor cells and help carry tumor-killing substances to them. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Octreotide acetate may interfere with the growth of tumor cells and slow the growth of neuroendocrine cancer. Giving cixutumumab together with everolimus and octreotide acetate may be a better treatment for neuroendocrine cancer.