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An International Phase 3 Randomized Trial of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (ADAPT)

Principal Investigator: Daniel Vaena, MD

1. Tumor Collection Study:
Participants in this research study have newly diagnosed advanced kidney cancer that requires surgery to remove a kidney called a nephrectomy.

Argos Therapeutics is conducting a research study of an experimental (investigational) drug (AGS-003) to see if it is effective against kidney cancer. An investigational drug is a medication that is still being studied and has not been approved for use in the general population by the United States Food and Drug Administration (FDA). AGS-003 is made for participants using a piece of their tumors collected after surgical removal of their kidneys.

No investigational treatments or procedures will be performed for the tumor collection part of this study. Eligible participants will allow the doctor to take a tumor sample on the day of their scheduled kidney removal surgery. If the doctor examining the removed kidneys determines that participants have a certain type of renal cancer called clear cell, they will be given further information about voluntary participation in the treatment part of the study.

2. Main/Treatment Study:
Participants in this research study have newly diagnosed advanced kidney cancer and have previously consented to allow for collection of their tumor samples, which may be used to make personalized experimental drugs for them called AGS-003.

Argos Therapeutics is conducting a research study of an experimental (investigational) drug AGS-003 to see if it is effective against kidney cancer. AGS-003 is made for participants by using a piece of their tumors collected after surgical removal of their kidneys along with a certain type of their own white blood cells. The resulting product is a type of immune cell called a dendritic cell, which is very good at activating the immune system against cancer cells. AGS-003 can be used in combination with the approved, regular medications most often prescribed for the treatment of kidne

age group:18 to 99 years trial start date:April 4, 2013
Gender Preference:none Trial End Date: July 1, 2016
Contact Info:

319-353-8914

Keywords: cancer ; IRB#201211501 ; phase 3 ; phase III ; vaena

A Phase 3 Randomized, Open-Label Study of Ponatinib versus Imatinib in Adult Patients with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase

Principal Investigator:Thomas Carter, MD

Participants in this study have recently been diagnosed with a type of leukemia (blood cancer) called chronic myelogenous leukemia (CML).

The purpose of this study is to evaluate ponatinib as a potential treatment for patients who have been newly diagnosed with CML. Ponatinib is an experimental anti-cancer drug.

This study will compare the effects of ponatinib to another drug called imatinib. Imatinib is approved by the United States Food and Drug Administration (FDA) for treating a variety of human cancers including newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in the chronic phase.

This study will enroll approximately 530 participants (subjects) in about 175 centers worldwide.

age group:18 to 99 years trial start date:April 2, 2013
Gender Preference:none Trial End Date: June 30, 2021
Contact Info:

Karen Parrott, 319-353-6347

Keywords: cancer ; carter ; chronic myelogenous leukemia (CML) ; imatinib ; IRB#201211504 ; phase 3 ; phase III ; ponatinib ; undefined

Trial for Single Tooth Extraction

Principal Investigator: Lauren Thomann

If you are 18-75 years old and are in need of a single tooth extraction (excluding molars) you may be eligible to participate in a study about the effectiveness of socket grafting for bone preservation. You must not be pregnant, a smoker, have uncontrolled diabetes, have a history of bisphosphonate use, or any active severe infectious diseases. Compensation is provided. If you are interested or would like more information, please contact Lauren at 319.335.7377, or by email at lauren-thomann@uiowa.edu.

age group:18 to 75 years trial start date:April 2, 2013
Gender Preference:none Trial End Date: October 2, 2013
Healthy Subject:Yes
Contact Info:

Call Lauren at 319.335.7377

Email Lauren at lauren-thomann@uiowa.edu

Keywords: extraction ; tooth

A Phase 3 Randomized, Open-Label Study of Ponatinib versus Imatinib in Adult Patients with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase

Principal Investigator:Thomas Carter, MD

Participants in this study have recently been diagnosed with a type of leukemia (blood cancer) called chronic myelogenous leukemia (CML).

The purpose of this study is to evaluate ponatinib as a potential treatment for patients who have been newly diagnosed with CML. Ponatinib is an experimental anti-cancer drug.

This study will compare the effects of ponatinib to another drug called imatinib. Imatinib is approved by the United States Food and Drug Administration (FDA) for treating a variety of human cancers including newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in the chronic phase.

This study will enroll approximately 530 participants (subjects) in about 175 centers worldwide.

age group:18 to 99 years trial start date:April 2, 2013
Gender Preference:none Trial End Date: April 2, 2023
Contact Info:

Karen Parrott, 319-353-6347

Keywords: cancer ; carter ; chronic myelogenous leukemia (CML) ; imatinib ; IRB#201211504 ; leukemia ; phase 3 ; phase III ; ponatinib

Comparator Study of 68Ga-DOTATOC PET/CT with Octreoscan + high-resolution, contrast-enhanced CT for diagnosis and staging in neuroendocrine tumors and other somatostatin receptor positive tumors

Principal Investigator: M. Sue O'Dorisio, MD

Participants in this research study have been diagnosed with a tumor such as carcinoid, neuroendocrine tumor, neuroblastoma, Ewing's sarcoma, or brain tumor that has cells with special proteins called somatostatin receptors.

The purpose of this research study is to see if the tumors can be identified using a special procedure called a positron emission tomography (PET) scan and see if it is as effective as having an Octreoscan and a diagnostic CT. Participants will have an injection with a radioactive drug called 68Gallium-DOTA-tyr3-Octreotide (68Ga-DOTATOC) that binds to tumor cells that have somatostatin receptors and then have a PET scan. A "low dose" computed tomography (CT) scan will then be done on the same scanner. 68Ga-DOTATOC is considered investigational, which means that it has not yet been approved by the U.S. Food and Drug Administration (FDA). The FDA has granted permission to conduct this study under an investigator's new drug (IND) application.

About 112 people will take part in this study conducted by investigators at the University of Iowa.

age group:2 to 99 years trial start date:April 1, 2013
Gender Preference:none Trial End Date: January 1, 2015
Contact Info:

Mary Schall, 319-356-3516

Keywords: brain tumor ; cancer ; carcinoid tumor ; IRB#201212736 ; neuroblastoma ; neuroendocrine tumor ; o'dorisio ; pediatric ; phase 2 ; phase II ; positron emission tomography (PET) scan ; somatostatin receptors ; undefined
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