Clinical Trials Update from NCI, September 2018

Clinical Trials Update from NCI, September 2018

Clinical Trials
Updates from the National Cancer Institute
Clinical Trials News
		Stimulating the Immune System Shrinks Some Slow-Growing Lymphomas In a small clinical trial involving patients with slow-growing B-cell lymphoma, injecting the compound SD-101 directly into tumors (in situvaccination) and giving low-dose radiation shrank the injected tumors and, frequently, tumors elsewhere in the body.
		Nivolumab and Ipilimumab Effective against Melanoma That Has Spread to the Brain Results from a clinical trial show that the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) halted the growth of or shrank metastatic brain tumors in more than half of participants with melanoma that had spread to the brain.
Moxetumomab Approved by FDA for Hairy Cell Leukemia FDA has approved moxetumomab pasudotox (Lumoxiti), a bacterial toxin–based drug, for the treatment of some patients with hairy cell leukemia (HCL). Moxetumomab is approved to treat patients with HCL who have already undergone at least two lines of standard treatments.
		Ribociclib Approval Expanded for Some Women with Advanced Breast Cancer FDA has expanded the approved uses of ribociclib (Kisqali) for some women with advanced breast cancer, including new uses in pre- and postmenopausal women. The expanded approvals were based on results from two randomized phase 3 clinical trials.
Find NCI-Supported Clinical Trials Use our search form to find a clinical trial or other research study that may be right for you or a loved one.
Clinical Trials Information for Patients and Caregivers
Paying for Clinical Trials As you think about taking part in a clinical trial, you will face the issue of how to cover the costs of care. Learn about the different types of costs related to taking part in a clinical trial, who is expected to pay for which costs, and tips for working with insurance companies.
Insurance Coverage and Clinical Trials Federal law requires most health insurance plans to cover routine patient care costs in clinical trials, under certain conditions, and most health plans cannot refuse to let you take part or limit your benefits. Learn about the conditions that insurance plans take into account and how to work with your insurance company.
NCI-Supported Clinical Trials That Are Recruiting Patients
Most drugs used in cancer treatment or prevention are administered either by mouth in pill form or injected into a vein (intravenously). However, researchers are also exploring the potential of giving drugs through the skin, or transdermally. Here are three ongoing clinical trials testing this innovative approach:
Topical Chemotherapy Application for Oral Squamous Cell Cancer This phase 1/2 trial is testing a topical chemotherapy application that provides a much smaller dose than the intravenous (IV) form of the chemotherapy, but has been shown in preclinical studies to be as effective and safer than IV chemotherapy. Researchers want to learn if treatment with PRV111 (Cisplatin Transmucosal System) will completely regress tumors and spare patients with oral squamous cell carcinoma from needing surgery. This topical agent is being developed with support from NCI’s Small Business Innovation Research (SBIR) Development Center.
Tamoxifen Gel for Women with Ductal Carcinoma In Situ (DCIS) This randomized phase 2 trial will compare afimoxifene, a gel form of the hormone therapy drug tamoxifen, with oral tamoxifen for the treatment of women with estrogen receptor (ER)-positive DCIS. Women with DCIS detected through screening mammograms and biopsy-confirmed ER expression will be randomly assigned to receive afimoxifene gel and a placebo pill or oral tamoxifen and placebo gel. Doctors will compare the expression of Ki67, a protein biomarker associated with cell proliferation, and other breast cancer biomarkers in each group of women.
Bexarotene Gel to Prevent Breast Cancer in Women at High Risk This phase 1 trial will determine the safety and best dose of bexarotene gel in preventing breast cancer in healthy women at high risk for breast cancer, such as those with a personal history of breast cancer or benign breast diseases, women with certain genetic mutations, or women with high breast cancer risk assessment scores. After the best dose is determined, an expansion group of participants will use the gel daily on one breast for 4 weeks. Doctors will examine side effects associated with bexarotene use, determine the concentration of bexarotene in the breast tissue, and compare levels of tissue biomarkers before and after application.

Clinical Trials Update from NCI, September 2018