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Clinical Trials Monthly - January 2013

This month we've focused on leukemia and breast cancer trials with two feature articles: GS-1101 (CAL-101) Against Chronic Lymphocytic Leukemia followed by three trials with this investigational drug working to become the next best treatment for CLL; and The SCCA “Prostate Dream Team Translational Cancer Research Project.

New Trials Added Since Dec.2012

Cancer News in Video from SCCA Physicians

Watch the collection of interviews that our doctors had with Patient Power’s Andrew Schorr at last month’s American Society of Hematology (ASH) Annual Meeting, including:

And be sure to subscribe to the SCCA Blog for the latest news on clinical trials from SCCA.

 


GS-1101 (CAL-101) Against Chronic Lymphocytic Leukemia

Drugs like rituximab and bendamustine can be effective against chronic lymphocytic leukemia (CLL) cells and can help control the disease. Drugs like GS-1101 (also known as CAL-101) block some of the cell functions that cause CLL to grow and survive and may also help control the disease. It is possible that giving rituximab and bendamustine together with GS-1101 may result in more activity against the CLL disease process than giving rituximab and bendamustine alone.

GS-1101 is an investigational drug, which means that it is still being tested in people and has not been approved by the United States Food and Drug Administration (FDA). In past research studies, more than 100 patients with CLL received GS-1101, either alone or in combination with other anticancer drugs. In those studies, GS-1101 may have helped control the CLL in some of the patients when given together with rituximab or when given alone. Regulatory authorities like the FDA have permitted the use of GS-1101 in these studies as part of a research process to find out if it could be approved for more general use when given together with rituximab and bendamustine in patients with CLL.


The following studies will treat patients with GS-1101 and other drugs in three separate clinical trials:
 

GS-1101 with Bendamustine and Rituximab for Chronic Lymphocytic Leukemia (FH 2597)
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-1101 (CAL-101) in Combination with Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL) (FH 2597) (NCT01569295)

The purpose of this study is to provide more information about whether giving rituximab and bendamustine along with GS-1101 is effective and safe for treating people with CLL. The study will show if adding GS-1101 to the standard treatment with rituximab and bendamustine will have a better effect on controlling CLL disease.

Rituximab and bendamustine are approved by the FDA as a treatment for patients with CLL. Many thousands of patients have received rituximab for treatment of CLL. Studies have also been done using bendamustine alone or in combination with rituximab as treatment for CLL. Investigator: John M. Pagel, MD, PhD

 GS-1101 with Rituximab for Previously Treated Chronic Lymphocytic Leukemia (FH 2612) 
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-1101 (CAL-101) in Combination with Rituximab for Previously Treated Chronic Lymphocytic Leukemia (FH 2612) (NCT01539512)

Rituximab is already approved by the FDA as a treatment for patients with CLL. Many thousands of patients have received rituximab for treatment of CLL. The purpose of this study is to learn more about whether giving rituximab and GS-1101 together is effective and safe for treating people with CLL, especially in patients who have medical problems that might make it difficult for them to receive chemotherapy for CLL. This is a primary study and will be followed by an extension study (detailed below) because it is unknown if using GS-1101 and rituximab together is better than using only rituximab. The primary study will compare these treatments. Investigator: John M. Pagel, MD, PhD

GS-1101 for Previously Treated Chronic Lymphocytic Leukemia (FH2613)
A Phase III, Double-Blind Extension Study Evaluating the Efficacy and Safety of Two Different Dose Levels of Single-Agent GS-1101 (CAL-101) as Therapy for Patients with Previously Treated Chronic Lymphocytic Leukemia (FH 2613) (NCT01539291)

A companion study to FH 2612, patients may participate in this study after they have participated in the primary study. The purpose of this study is to learn more about whether GS-1101 is effective and safe for treating people with CLL, especially in patients who have medical problems that might make it difficult for them to receive chemotherapy for CLL. The findings from the primary study and this extension study will provide data on how GS-1101 works when given together with rituximab, how GS-1101 helps when given alone, and whether a change in dose may help people with CLL that appears to be resistant to the drug. This study will focus on the effects of giving GS-1101 alone, and will provide information on whether people show any medical problems when they take the drug for a longer period of time. Investigator: John M. Pagel, MD, PhD

The BEACON Study-Breast Cancer Outcomes with NKTR-102 (UW11054)
The BEACON Study (Breast Cancer Outcomes with NKTR-102): A Phase III Open-Label, Randomized, Multicenter Study of NKTR-102 Versus Treatment of Physician’s Choice (TPC) in Patients with Locally Recurrent or Metastatic Breast Cancer Previously Treated with an Anthracycline, a Taxane and Capecitabine (UW11054) (NCT01492101)

The study is designed as an open-label, randomized, parallel, two-arm, multicenter, international Phase III study in patients with recurrent or metastatic breast cancer previously treated with cytotoxic chemotherapy regimens.

The primary study objective is to compare overall survival of patients who receive NKTR-102, given once every 21 days, to patients who receive treatment of Physician’s Choice selected from a list of seven single-agent intravenous therapies. Investigator: Jennifer M. Specht, MD

SCCA Part of Prostate Dream Team Translational Cancer Research Project

The Prostate Dream Team Translational Cancer Research Project is about to begin at Seattle Cancer Care Alliance. The team, formed by the Prostate Cancer Foundation (PCF), Stand Up To Cancer (SU2C), and the American Association for Cancer Research (AACR), SU2C’s scientific partner, is made up of five leading prostate cancer research centers in Ann Arbor, New York, Boston, and London, as well as Seattle Cancer Care Alliance. The project, called “Precision Therapy for Advanced Prostate Cancer,” received a $10 million three-year grant to study and address resistance pathways for hormone refractory prostate cancer, especially metastatic disease.

“We are sequencing all of the genes in metastases from men dealing with resistant prostate cancers, a process that used to take a year and $500,000. Now it takes four weeks and $10,000,” says Bruce Montgomery, MD, the SCCA oncologist who is participating in this multi-institutional project.

The sequencing will identify any mutations in genes that are specific to these cancers and might reveal new ways to treat cancers that are often resistant to standard therapies.

“If mutations are found and we can target them with drugs that already exist but haven’t been used to treat prostate cancer before, then we will prescribe those medications with the potential that these could provide real benefit,” Montgomery says. “Defining mutations which occur in advanced, metastatic cancer has never been done in any systematic way, and this effort could define new targets for therapy that we’ve never recognized before in prostate cancer.”

New SCCA Trials Opened Since Dec. 1, 2012

Prostate Cancer

Phase I — AML or MDS
A Phase IB Study to Evaluate the Safety and Preliminary Efficacy of PF-04449913, an Oral Hedgehog Inhibitor, in Combination with Intensive Chemotherapy, Low-Dose Ara-C, or Decitabine in Patients with Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome (NCT01546038)

Phase I — Sarcoma
A Study of the Safety and Efficacy of the Combination of Gemcitabine and Docetaxel in Metastatic Soft-Tissue Sarcoma (NCT01574716)


Adult Bone Marrow Transplant News

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.

Pediatric Bone Marrow Transplant News

Read about important outcomes research at the Fred Hutch that may benefit your patients.

Clinical Trials Monthly

Each issue of Clinical Trials Monthly highlights several of the more than 200 clinical trials that are currently recruiting patients at SCCA.

The Leading Edge Newsletter

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.