Clinical Trials Update from NCI, September 2017

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Clinical Trials
Updates from the National Cancer Institute
Clinical Trials News
Technician looking at mammogram x-rays  

NCI-funded TMIST Study Compares 2-D and 3-D Mammography for Finding Breast Cancers

The Tomosynthesis Mammographic Imaging Screening Trial (TMIST), the first randomized trial to compare two types of digital mammography for breast cancer screening, is now open for enrollment.

 Thumbnail image of Patient Safety video  

Video—Patient Safety in Clinical Trials

Patient safety is of paramount importance in cancer clinical trials. This new video discusses how patient rights and safety are protected in clinical research.

Manufactured CAR T cells ready for infusion  

CAR T-Cell Therapy Approved for Some Children and Young Adults with Leukemia

FDA has approved tisagenlecleucel (Kymriah™), a type of immunotherapy called CAR T-cell therapy, for some children and young adults with advanced acute lymphoblastic leukemia (ALL). The approval was based on a multicenter clinical trial involving 63 children and young adults with B-cell ALL that had relapsed or resisted treatment.

   Model of the drug olaparib binding to part of the PARP1 enzyme in a cancer cell, preventing the enzyme from repairing damaged DNA. Credit: Dawicki-McKenna JM, Molecular Cell 2015. doi:10.1016/j.molcel.2015.10.013  

FDA Approves Olaparib as Maintenance Therapy for Recurrent Ovarian Cancer

FDA has granted full approval to olaparib tablets (Lynparza®) as maintenance treatment for patients with recurrent ovarian cancer who are having partial or complete responses to platinum-based chemotherapy. The approval is based on findings from two randomized clinical trials involving patients with recurrent ovarian cancer.

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Clinical Trials Information for Patients and Caregivers

Deciding to Take Part in a Clinical Trial


This page discusses things to consider when you are deciding whether to take part in a clinical trial.


Questions to Ask Your Doctor about Treatment Clinical Trials


Taking part in a cancer treatment clinical trial is a big decision. This page presents a list of questions you may want to ask your doctor about before deciding to participate in a clinical trial.

NCI-Supported Clinical Trials that Are Recruiting Patients 

Lutetium Lu 177-DOTA-TATE in Treating Patients with Metastatic Pheochromocytoma or Paraganglioma That Cannot Be Removed by Surgery

This phase 2 trial studies how well lutetium Lu 177-DOTA-TATE works in treating patients with pheochromocytoma or paraganglioma that has spread to other places in the body and cannot be removed by surgery.


T-Cell Immunotherapy and Aldesleukin in Treating Patients with Vulvar High-Grade Intraepithelial Lesions that are HPV-16 Positive and Cannot Be Removed by Surgery

This phase 1 trial studies the safety of T-cell immunotherapy and aldesleukin in treating patients with vulvar high-grade intraepithelial lesions (HSIL) that are human papilloma virus-16 (HPV-16) positive and which surgery has failed to control. T cells will be harvested from the patient’s blood and genetically engineered to express a receptor that recognizes the E6 protein on cells infected with HPV-16. The genetically engineered T cells will then be put back into the patient.

Anti-KRAS G12V Peripheral Blood Lymphocytes, Chemotherapy, and Aldesleukin in Treating Patients with KRAS G12V-Positive and HLA-A*1101-Positive Cancer

This phase 1/2 trial will assess the safety and efficacy of anti-KRAS G12V peripheral blood lymphocytes, chemotherapy, and aldesleukin, and see how well they work in treating patients with KRAS G12V-positive and HLA-A*1101-positive cancer. T cells will be harvested from the patient’s blood and genetically engineered to express a receptor that recognizes G12V-mutated variant of KRAS. The genetically engineered T cells will then be put back into the patient.