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Anus Neoplasms clinical trials

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NCT ID: NCT02399813 Completed - Rectal Cancer Clinical Trials

A Phase 2 Study of Axalimogene Filolisbac (ADXS11-001) in Participants With Carcinoma of the Anorectal Canal

Start date: June 2, 2016
Phase: Phase 2
Study type: Interventional

This is a single arm Phase 2 study. Stage 1 and 2 of the study are monotherapy evaluations of ADXS11-001 in 31 and 24 participants, respectively with persistent/recurrent, loco-regional or metastatic squamous cell carcinoma (SCCA) of the anorectal canal that have received at least 1 regimen for the treatment of advanced disease.

NCT ID: NCT02384005 Recruiting - Anus Neoplasms Clinical Trials

The Feasibility of Self or Partner-assisted Digital Anal Exam Screening

Start date: February 2015
Phase: N/A
Study type: Interventional

There is no standard screening protocol for anal cancer even as disease incidence increases. This single-visit study will clarify if single persons can do a self-digital anal exam, or perhaps the exam requires a partner, or if, in fact, the exam requires a clinician for reasons of safety, accuracy, or acceptability. The investigators hypothesize that men having sex with men's digital anal exam (DAE) findings will have moderate or substantial agreement with a nurse practitioner DAE for detecting an anal abnormality (defined as condylomas, hemorrhoids, fissures, and malignant tumors). As a secondary hypothesis the investigator believe a partner-assisted DAE conducted within a couple will have better agreement with the nurse practitioner DAE than will a self-DAE conducted by a single person.

NCT ID: NCT02379520 Active, not recruiting - Clinical trials for Human Papillomavirus-Related Carcinoma

HPV-16/18 E6/E7-Specific T Lymphocytes, Relapsed HPV-Associated Cancers, HESTIA

HESTIA
Start date: September 2015
Phase: Phase 1
Study type: Interventional

Subjects have a type of cancer that has been associated with an infection with a virus called human papilloma virus (HPV). The cancer has come back, has not gone away after standard treatment or the subject cannot receive standard treatment. This is a research study using special immune system cells called HPVST cells, a new experimental treatment. Investigators want to find out if they can use this type of treatment in patients with HPV-cancers. They have discovered a way to grow large number of HPV-specific T cells from the blood of patients with HPV-cancers. They want to see if these special white blood cells, called HPVST cells, that will have been trained to kill HPV infected cells can survive in the blood and affect the tumor. They will also see if they can make the T cells more active against the HPV-cancers by engineering them to be resistant to the TGF-beta chemical that these HPV-cancers produce. They will grow these HPVST cells from the patient's blood. The purpose of this study is to find the biggest dose of HPVSTs that is safe, to see how long they last in the body, to learn what the side effects are and to see if the HPVSTs will help people with HPV associated cancers. If the treatment with HPVST cells alone proves safe (Group A), additional group of patients (Group B) will receive Nivolumab in addition to HPVST cells in a lymphodepleted environment. Nivolumab is an antibody therapy that helps T cells control the tumor and it is FDA approved for the treatment of certain types of cancers, including Hodgkin's lymphoma. Lymphodepletion will decrease the level of circulating T cells prior to infusion of HPVST cells, thereby giving them room to expand. The purpose of this part of the study is to find out if TGF-beta resistant HPVST cells in combination with Nivolumab are safe, how long they last in the body and if they are more effective than HPVST cells alone in controlling the tumor.

NCT ID: NCT02379039 Completed - Lung Cancer Clinical Trials

Multimodal Monitoring of Radiotherapy Response in Squamous Cell Cancer

MORRIS
Start date: May 2015
Phase:
Study type: Observational

The study's aim is to define imaging and molecular bio-markers for prediction of radiotherapy response of squamous cell carcinomas, in an early treatment phase.

NCT ID: NCT02369939 Recruiting - Anal Carcinoma Clinical Trials

Effects of Deep Regional Hyperthermia in Patients With Anal Carcinoma Treated by Standard Radiochemotherapy

HYCAN
Start date: December 2014
Phase: Phase 3
Study type: Interventional

Randomized study to investigate the efficacy of deep regional hyperthermia in patients with anal carcinoma treated by standard radiochemotherapy with MMC and 5-FU.

NCT ID: NCT02314169 Active, not recruiting - Clinical trials for Anal Canal Squamous Cell Carcinoma

Nivolumab With or Without Ipilimumab in Treating Patients With Refractory Metastatic Anal Canal Cancer

Start date: May 13, 2015
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well nivolumab with or without ipilimumab works in treating patients with anal canal cancer that has not responded to previous treatment (refractory) and that has spread from where it first started (primary site) to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

NCT ID: NCT02280811 Completed - Cervical Cancer Clinical Trials

T Cell Receptor Immunotherapy Targeting HPV-16 E6 for HPV-Associated Cancers

Start date: October 14, 2014
Phase: Phase 2
Study type: Interventional

Background: The NCI Surgery Branch has developed an experimental therapy for treating patients with 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. Researchers want to test this on human papilloma virus (HPV)-associated cancers. Objective: - The purpose of this study is to determine a safe number of these cells to infuse and to see if these particular tumor-fighting cells (Anti-HPV E6) can shrink tumors associated with HPV and test the toxicity of this treatment. Eligibility: - Adults age 18-66 with an HPV-16-associated cancer. Design: - Work up stage: Patients will be seen as an outpatient at the 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 HPV E6 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 HPV E6 cells and aldesleukin. They will stay in the hospital for about 4 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 take up to 2 days.

NCT ID: NCT02199236 Active, not recruiting - Clinical trials for Rectal or Anal Cancer

Dose Escalation Trial of Endoluminal High-Dose-Rate Brachytherapy With Concurrent Chemotherapy for Rectal or Anal Cancer in Patients With Recurrent Disease or Undergoing Non-Operative Management

Start date: July 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is to see what amount of radiation is safe to give to rectal or anal cancer patients who are being treated with a procedure called brachytherapy.

NCT ID: NCT02162641 Withdrawn - Clinical trials for Squamous Cell Carcinoma of the Anus

Study to Determine the Feasibility of Sentinel Node Biopsy in Patients With Anal Cancer

R-SeNSAR
Start date: September 2014
Phase: N/A
Study type: Observational

The purpose of this study is assess the technical and operational feasibility of a specialised biopsy technique, sentinel lymph node biopsy (SLNB), in patients with anal cancer.

NCT ID: NCT02145416 Completed - Anal Cancer Clinical Trials

ART: Anal Squamous Cell Carcinoma: Investigation of Functional Imaging During chemoRadioTherapy

ART
Start date: January 27, 2015
Phase:
Study type: Observational

This is a single arm, single centre imaging study which will be offered to all consecutive, eligible patients receiving radical chemoradiation therapy (CRT) for anal cancer within Oxford University Hospitals. Investigations - Dynamic contrast enhanced magnetic resonance imaging (DCE MRI) - Diffusion weighted magnetic resonance imaging (DWI MRI) - MRI scan designed to measure the T1 or produce T1-weighed images (T1 MRI) - MRI scan designed to measure the T2* or produce T2*-weighed images (T2* MRI) - Perfusion computed tomography (pCT) - Fludeoxyglucose positron emission tomography (FDG PET/CT) Study Design: Observational Target Population: Patients undergoing radical CRT for anal cancer in Oxford University Hospitals National Health Service (NHS) Trust. Duration on study: Patients should be on study for a maximum of 5 months. Patient care post-trial: Follow up as per local standard. No. of Study Site(s): Single Centre, United Kingdon (UK) End of study: Last Patient, last assessment of response. Patients should be on study for a maximum of 5 months.