Clinical Trials Monthly - March 2014
The knowledge we gain from clinical trials helps us develop more effective, less toxic cancer treatments. Each month we publish this newsletter with our Hotlist of new clinical trials that may be of interest to you and your patients.
- PI3Kδ Inhibition by Idelalisib in Patients with Relapsed Indolent Lymphoma
- Inotuzumab Ozogamicin for Relapsed or Refractory Acute Lymphoblastic Leukemia
- PCI-32765 (Ibrutinib) for Refractory Follicular Lymphoma
- Alisertib in Combination with Paclitaxel for Small Cell Lung Cancer
- Chemotherapy or Chemotherapy + Radiation for Rectal Cancer Patients Undergoing Surgery (The PROSPECT Trial)
SCCA investigator Ajay K. Gopal, MD, was the first author on a January 2014 New England Journal of Medicine paper about idelalisib, an orally active selective PI3Kδ inhibitor that, in a Phase I study, showed antitumor activity in patients with previously treated indolent non-Hodgkin’s lymphoma.
This paper detailed the single-group, open-label, Phase II study (PI3Kδ Inhibition by Idelalisib in Patients with Relapsed Indolent Lymphoma) that SCCA physicians were involved in designing and had the highest accrual of patients for. It featured 125 patients with indolent non-Hodgkin’s lymphoma who had not had a response to rituximab and an alkylating agent or had a relapse within six months after receipt of those therapies. These patients received 150 mg of idelalisib twice daily until the disease progressed or the patient withdrew from the study.
“New therapies, like idelalisib, have the potential to dramatically alter the treatment paradigm for indolent B-cell lymphomas and emphasize the importance of consideration of clinical trials for ones’ patients,” said Gopal.
SCCA was the highest-accruing center in the country for this study, in which idelalisib showed antitumor activity in patients who had received extensive prior treatment.
“This trial demonstrates the kinds of novel, breakthrough therapies we can offer at our institution,” said Jennifer Roden, SCCA research manager in the University of Washington hematologic malignancies group. The full article is available in the January 22, 2014 issue of the New England Journal of Medicine, at NEJM.org.
Inotuzumab Ozogamicin for Relapsed Or Refractory Acute Lymphoblastic Leukemia
An Open-Label, Randomized Phase III Study of Inotuzumab Ozogamicin Compared to a Defined Investigator’s Choice in Adult Patients with Relapsed or Refractory CD22-Positive Acute Lymphoblastic Leukemia (ALL) (NCT01564784)
The purpose of this research study is to learn if the investigational drug inotuzumab ozogamicin is an effective treatment compared to regimens used in patients with relapsed or refractory acute lymphoblastic leukemia (ALL). Inotuzumab ozogamicin has not been approved by the U.S. Food and Drug Administration (FDA). Although commonly used, none of the chemotherapy regimens used in this study are FDA-approved for ALL treatment. This study will also look at how the body distributes the drug and the side effects associated with it. The goal is to enroll 194 to 292 patients. The study is being conducted globally at approximately 190 sites. Investigator: Ryan D. Cassaday, MD
The purpose of this study is to assess the effects of and response to ibrutinib to treat follicular lymphoma. This study will enroll approximately 110 patients. Currently, more than 736 patients have taken ibrutinib in 19 other studies. Ibrutinib is an experimental drug, and a Bruton’s Tyrosine Kinase (BTK) inhibitor that blocks an enzyme (protein) that affects how non-Hodgkin’s lymphoma-affected white blood cells grow and survive. Blocking this enzyme is an important mechanism in killing these cancer cells. Ibrutinib is not approved by any regulatory authority in any country, including the FDA. Investigator: Ajay K. Gopal, MD
Alisertib in Combination with Paclitaxel for Small Cell Lung Cancer
This is a double-blind, randomized study of an investigational drug called alisertib, also known as MLN8237. Alisertib is given orally as tablets, and was developed as a possible treatment for patients with small cell lung cancer as a second-line therapy in combination with paclitaxel. The purpose of this study is to measure the safety and length of disease response during and after treatment with alisertib in combination with paclitaxel or a placebo in combination with paclitaxel. Patients will provide blood and a tumor tissue sample for biomarker research, which is part of this evaluation. Researchers will also perform genetic testing to identify, confirm, and validate biomarkers to alisertib (MLN8237). Investigator: Christina S. Baik, MD, MPH
Chemotherapy or Chemotherapy + Radiation for Rectal Cancer Patients Undergoing Surgery (The Prospect Trial)
A Phase II/III Trial of Neoadjuvant FOLFOX, with Selective Use of Combined Modality Chemoradiation versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Undergoing Low Anterior Resection with Total Mesorectal Excision (NCT01515787)
Known as the PROSPECT Trial, this is a cooperative group trial targeting patients with locally advanced rectal cancer. The purpose of this study is to compare the effects of the standard treatment of 5FUCMT (5-fl uorouracil and capecitabine plus radiation therapy) with a chemotherapy drug combination known as FOLFOX (5-fl uorouracil [5-FU], oxaliplatin, and leucovorin). Depending on response to the FOLFOX, treatment may also include a selective use of 5FUCMT. The drugs in the FOLFOX regimen are all approved by the FDA and have been used routinely since 2002 to treat patients with advanced colorectal cancer. More information about the trial is available on the SCCA Blog. Investigators: Alessandro Fichera, MD, and Veena Shankaran, 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.