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Colonic Neoplasms clinical trials

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NCT ID: NCT01287130 Completed - Colon Cancer Clinical Trials

AZD6244 With Cetuximab for Solid Tumors and Colorectal Cancer

Start date: January 7, 2011
Phase: Phase 1
Study type: Interventional

Background: - The experimental cancer treatment drug AZD6244 has been shown to block signals that tell cancer cells to grow. Cetuximab, a drug approved to treat cancer of the head, neck, colon, and rectum, also blocks signals that tell cancer cells to grow. Researchers are investigating the highest safe dose of AZD6244 to give with cetuximab, and will also investigate the effectiveness of this drug combination in individuals who have colorectal cancer that involves a particular protein known as the K-RAS protein. Cetuximab is not used to treat colorectal cancer with K-RAS tumors because it has not been shown to be effective, but researchers believe that adding AZD6244 to cetuximab may improve how well cetuximab works, even in people with K-RAS tumors. Objectives: - To evaluate the safety and effectiveness of AZD6244 in combination with cetuximab for solid tumors that have not responded to standard treatment. - To evaluate the safety and effectiveness of AZD6244 in combination with cetuximab for colorectal cancer that involves the K-RAS protein and has not responded to standard treatment. Eligibility: - Individuals at least 18 years of age who have been diagnosed with solid tumors that have not responded to standard treatment. - Individuals at least 18 years of age who have been diagnosed with colorectal cancer that has not responded to standard treatment. Design: - This protocol will involve two separate studies: an initial study to establish the highest safe and effective dose of AZD6244 and cetuximab in individuals with solid tumors, and an expansion study of AZD6244 and cetuximab in individuals with colorectal cancer involving the K-RAS protein. - Participants will be screened with a full medical history and physical examination, blood samples, imaging studies, and other tests as required by the researchers. - AZD6244 is a capsule to be swallowed once or twice a day, every day, with water on an empty stomach. Cetuximab will be given intravenously once a week, over 2 hours for the first dose and over an hour for every following dose. This combination of daily AZD6244 and weekly cetuximab will be repeated in 28-day cycles of treatment. Participants will keep a diary to record the time of taking AZD6244 each day, as well as any side effects. - Participants will have frequent blood tests and other exams during the first cycle of treatment, up to five visits to the National Institutes of Health (NIH) and other visits to their local doctor to in the first 28-day cycle. - During subsequent cycles, participants will have four visits to NIH and four visits to your local doctor for examinations, blood tests, and imaging studies. - Participants may continue to receive the AZD6244 with cetuximab for up to 6 cycles, until the tumor grows, unacceptable side effects development, or the participant or participant's doctor decides to stop participation. There will be a final study visit that repeats the procedures performed during the screening visit....

NCT ID: NCT01254617 Completed - Clinical trials for Salivary Gland Squamous Cell Carcinoma

Lenalidomide and Cetuximab in Treating Patients With Advanced Colorectal Cancer or Head and Neck Cancer

ADCC
Start date: February 10, 2011
Phase: Phase 1
Study type: Interventional

This phase I trial studies the side effects and the best dose of lenalidomide when given together with cetuximab in treating patients with colorectal cancer or head and neck cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Biological therapies, such as lenalidomide, use substances made from living organisms that may stimulate the immune system in different ways and stop tumor cells from growing. Monoclonal antibodies, such as cetuximab, may block tumor growth in different ways by targeting certain cells. Giving lenalidomide together with cetuximab may be a better treatment for colorectal cancer or head and neck cancer.

NCT ID: NCT01191684 Completed - Clinical trials for Stage IV Pancreatic Cancer

Vaccine Therapy in Treating Patients With Colorectal, Stomach, or Pancreatic Cancer

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

RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with colorectal, stomach, or pancreatic cancer.

NCT ID: NCT01187641 Completed - Colon Cancer Clinical Trials

Comparison of the Diagnostic Accuracy of 3D Volume Acquisition MRI With CT in Staging Colonic Cancer

Start date: August 18, 2010
Phase: N/A
Study type: Observational

The purpose of this study is to determine whether MRI is more accurate than CT in determining the T stage, N stage, depth of tumour invasion and extra mural venous invasion (EMVI) preoperatively in colon cancer.

NCT ID: NCT01147965 Completed - Breast Cancer Clinical Trials

Active Immunotherapy CEA Vaccine in Patients With Malignancies Expressing CEA

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

The purpose of this study is to find out what effects (good and bad) that a cancer vaccine has on you and your cancer. The cancer vaccine is called Ad5 [E1-, E2b-]-CEA(6D)or ETBX-011 and is made by Etubics. This vaccine is based on a virus called an adenovirus but it has been changed to express the protein CEA that is found on some cancer cells. Therefore, the vaccine can tell the immune system to attack cancer cells which make CEA. The investigators are trying to determine whether giving this virus is safe and whether this causes a strong immune system attack on the cancer. ETBX-011 is an investigational drug.

NCT ID: NCT01133132 Completed - Colon Cancer Clinical Trials

Interactive Cancer Communication System (ICCS) Directed Physical Activity Enhancement for Colon Cancer Survivors

Start date: February 2010
Phase: N/A
Study type: Interventional

This study will develop and test the benefits of a new ICCS (Interactive Cancer Communication System), a mobile Comprehensive Health Enhancement Support System (Survivorship CHESS) in colon cancer survivors. Survivorship CHESS will provide information, tools, and a support system based on our previous work with FRESH START and CHESS, two highly successful interventions that have promoted lifestyle change among cancer patients and survivors. Survivorship CHESS will be designed to help subjects develop 1) competence in information gathering, decision-making, and behaviors they are trying to change, 2) social support systems to help deal with the cancer experience, and 3) autonomy that comes with regaining a sense of control over their lives; this in turn, will help them adopt or maintain healthy lifestyle behaviors and improve their quality of life.

NCT ID: NCT01126346 Completed - Clinical trials for Unspecified Childhood Solid Tumor, Protocol Specific

Quality of Life and Survivorship Care in Patients Undergoing Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

HOPE
Start date: May 2010
Phase: N/A
Study type: Interventional

RATIONALE: An orientation and patient education program and telephone counseling may help improve the quality of life in patients with peritoneal surface malignancies. PURPOSE: This clinical trial studies quality of life and survivorship care in patients undergoing surgery and chemotherapy for peritoneal surface malignancies.

NCT ID: NCT01113736 Completed - Rectal Cancer Clinical Trials

Pilot Study Evaluating the Efficacy of AlloMEM After Loop Ileostomy

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

The objective of this study is to investigate whether the use of Human Peritoneal Membrane (HPM) in a temporary loop ileostomy is beneficial to patients. Benefit will be defined, for purposes of this study, as a decrease in adhesions resulting in decreased operative time during ileostomy closure, with promotion of peritoneal remodeling.

NCT ID: NCT01099111 Completed - Crohn Disease Clinical Trials

Advanced Metagenomic Analysis of Human Colonic Microbiota in Patients With Chronic GI Disorders

Start date: July 2010
Phase: N/A
Study type: Observational

This clinical trial hypothesize that Gut Microbiota (bacteria, viruses, fungi)play a major role in the occurrence and progression of many chronic gastrointestinal diseases like Irritable Bowel Syndrome, Inflammatory Bowel Diseases and Colo-Rectal Cancer. Hence, aims to study the spectrum of such microbiota in these patients as compared to normal subjects, by utilizing metagenomic techniques rather than cultural methods.

NCT ID: NCT01091558 Completed - Ulcerative Colitis Clinical Trials

Study of Effects of L-Arginine in Colitis and Colon Cancer

Start date: September 2009
Phase: N/A
Study type: Observational

The purpose of this study is to look at the importance of L-Arginine in the digestive tract. L-Arginine is an amino acid and is important in making proteins within the cell. The evaluation of colon tissue, blood, urine, diet, health history, and symptoms will help us learn more about L-Arginine and ulcerative colitis. The investigators believe these studies will provide new insights into the treatment for Inflammatory Bowel Disease (ulcerative colitis) and nutritional needs. The investigators plan to enroll 200 participants in this study over the next two years.