Clinical Trials Monthly - April 2014
The knowledge we gain from clinical trials helps develop more effective, less toxic cancer treatments. Each month we publish this newsletter with our HOTLIST of the newest clinical trials that might be of interest to you and your patients.
- New Trial Studies Anti-Tumor Activity of Gefitinib with Anti Pd-L1 MEDI4736 In Non-Small Cell Lung Cancers
- Alisertib (MLN8237) in Combination with Paclitaxel for Small Cell Lung Cancer
- A+AVD vs. ABVD as Frontline Therapy for Hodgkin’s Lymphoma
- Galeterone for Castration Resistant Prostate Cancer (ARMOR2)
- AGS15E for Metastatic Urothelial Cancer
New Trial Studies Anti-Tumor Activity of Gefitinib with Anti Pd-L1 MEDI4736 In Non-Small Cell Lung Cancers
Non-small cell lung cancer (NSCLC) is notoriously difficult to treat or cure. Resectable disease may be cured by surgery or surgery followed by chemotherapy, and radiation therapy can provide local control in unresectable disease, but few people are cured. The need for effective NSCLC treatments is great.
Seattle Cancer Care Alliance (SCCA) has an open Phase I study that will determine a safe dose of anti-PDL1 drug, MEDI4736, in combination with gefitinib to shrink tumors. This is the first time for this combination to be tested in patients. MEDI4736 is an antibody that acts on the PD-L1 ligand. It has not been approved by any authority that regulates new medicines. Gefitinib is an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) that blocks the action of EGFR, which is commonly found on the surface of cancer cells and causes tumors to grow. It has not been approved in the United States, but has been approved in other countries in Europe and Asia.
Based on results of preliminary non-clinical studies, it is assumed that MEDI4736 in combination with gefitinib treatment may have increased efficacy in patients with a variety of advanced NSCLC compared to EGFR TKI (gefitinib) monotherapy. This study will measure levels of MEDI4736 and gefitinib in the blood and determine the effect on the body including immune responses and potential adverse reactions. SCCA’s principal investigator in this trial is Laura Q.M. Chow, MD. Read more about this study.
Alisertib (MLN8237) in Combination with Paclitaxel for Small Cell Lung Cancer
A Randomized, Double-Blind, Placebo-Controlled, Phase II Clinical Trial of Alisertib (MLN8237) in Combination with Paclitaxel versus Placebo in Combination with Paclitaxel as Second-Line Therapy for Small Cell Lung Cancer (SCLC) (NCT02038647)
In this double-blind study, patients will receive alisertib (also known as MLN8237), or placebo, in combination with taxol (Paclitaxel). Alisertib, an oral tablet, is being developed as a possible treatment for small cell lung cancer as a second-line therapy in combination with Paclitaxel. This study’s purpose is to measure safety and the length of time during and after treatment that disease responds after patients are treated with alisertib in combination with Paclitaxel, or placebo in combination with Paclitaxel. Patients will give blood and a stored tumor tissue sample (if available) for the biomarker research portion of this study. Genetic testing of these samples will identify, confirm, and validate biomarkers. Researchers are looking for how differences in genetic makeup may influence the way people respond and develop side effects to MLN8237. Investigator: Christina S. Baik, MD, MPH
A+AVD versus ABVD as Frontline Therapy for Hodgkin’s Lymphoma
Brentuximab vedotin (Adcetris) targets CD30 on the cancer cell. The U.S. Food and Drug Administration (FDA) has approved the drug for treating some types of lymphoma when other therapies have failed. The goal of this Phase III, randomized, two-arm, multicenter study is to compare the modified progression-free survival of Adcetris when it is administered with AVD (doxorubicin, vinblastine, and dacarbazine; abbreviated A+AVD) as compared to treatment with doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) for frontline treatment of advanced classical Hodgkin’s lymphoma. This study will also look for differences in DNA, RNA, and proteins related to the disease and its response to the study drug. Investigator: Ajay K. Gopal, MD
Galeterone for Castration Resistant Prostate Cancer (ARMOR2)
This is a two-part trial to study an investigational new drug, galeterone. This trial will evaluate galeterone to confirm the safest dose and fi nd out how it moves through the body. Researchers hope to determine if it is effective at treating prostate cancer when other treatments have failed and gain more information about possible side effects. It has only been approved by the FDA for investigational use. Animal tests have shown that galeterone can reduce the size of prostate cancer tumors. These tests and other laboratory tests suggest that galeterone can make it harder for prostate cancer cells to make testosterone, prevent whatever testosterone is still around from attaching to the androgen receptor, and reduce the number of androgen receptors in the prostate cancer tumor. Together, these three effects may deprive prostate cancer tumor cells of what they need to grow, although whether these effects will be seen in humans is not yet known. Investigators: Bruce Montgomery, MD
AGS15E For Metastatic Urothelial Cancer
AGS15E is an investigational drug; an antibody drug conjugate (ADC) has only been approved by the FDA for investigational use. It consists of a fully human monoclonal antibody attached to a chemotherapy drug called monomethyl auristatin E (MMAE). The monoclonal antibody carries the chemotherapy drug to cancer cells that have the SLITRK6 protein (the target protein). Patients receive AGS15E as a 30-minute infusion once weekly for three weeks of a four-week cycle. This is the first study in humans of AGS15E. The side effects of this drug in humans are not known. Investigator: Evan Yu, MD
The SCCA Adult Bone Marrow Transplant News is a publication presenting the latest information on bone marrow transplant research at SCCA, providing up-to-date information for all health care professionals caring for transplant patients.
Read about important outcomes research at the Fred Hutch that may benefit your patients.
Each issue of Clinical Trials Monthly highlights several of the more than 200 clinical trials that are currently recruiting patients at SCCA.
Each quarterly Leading Edge newsletter will highlight a new topic to give you the latest news on leading-edge therapies that SCCA physicians are offering.