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Clinical Trials Monthly - August 2013

Each month we publish this newsletter with our Hotlist of the newest clinical trials that might be of interest to you and your patients. In this issue, we discuss a new standard of care for AML or MDS patients along with individual profiles of the following trials:

New Research Study: Outpatient Induction Chemotherapy for AML or MDS

Traditionally, patients requiring initial intensive remission induction therapy for hematological cancers have been hospitalized until their blood counts recover, approximately four to five weeks after initiation of chemotherapy. But recent evidence from a Seattle Cancer Care Alliance (SCCA) study of patients with acute myeloid leukemia (AML) and high risk myelodysplastic syndrome (MDS) has documented the safety and effectiveness of early discharge, prior to blood count recovery, for select patients.

This study (Haematologica 2011;96:914-917) signaled a turning point in the routine management of acute leukemia patients at SCCA—with many patients now discharged immediately following chemotherapy, reducing the initial inpatient stay from four to fi ve weeks to seven days. This led to the recent initiation of a new clinical trial involving complete outpatient administration and monitoring of chemotherapy for AML or MDS.

The new trial is called “Feasibility of Outpatient Induction Chemotherapy for Adult Patients with Newly Diagnosed Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome.” The study started in June 2013, and will enroll 25 patients who are 18 to 59 years of age and in generally good condition. Patients must have a caregiver and live within 30 minutes of SCCA’s South Lake Union clinic.

According to Principal Investigator Pamela S. Becker, MD, PhD, associate professor in the Division of Hematology at the UW School of Medicine, the primary study goals are completion of chemotherapy without hospitalization for at least half of the patients without an increase in mortality. Patients will receive all their induction chemotherapy in the outpatient infusion center at SCCA and will stay in a nearby private residence or hotel. Researchers will also monitor patient quality of life and the costs of treatment.

Lymphoma

Rituximab + Lenalidomide vs. Chemotherapy (RELEVANCE-7636)

A Phase III Open-Label Randomized Study to Compare the Efficacy and Safety of Rituximab Plus Lenalidomide (CC-5013) Versus Rituximab Plus Chemotherapy Followed by Rituximab in Subjects With Previously Untreated Follicular Lymphoma. The “RELEVANCE” Trial (Rituximab Lenalidomide Versus Any Chemotherapy)

Lenalidomide (Revlimid) is an immunomodulary, a drug that alters the body’s immune system and may interfere with the development of tiny blood vessels that support tumor growth. This study will determine if lenalidomide given along with rituximab can help control follicular lymphoma (FL) and also increase the length of response (complete response [CR] or partial response [PR]) compared to the current standard of care treatment (rituximab plus chemotherapy). CR occurs when there is no longer any evidence of lymphoma in radiologic scans or bone marrow biopsy. A PR occurs when the amount of disease has decreased compared to when the patient started the study but not completely disappeared.

Lenalidomide given alone or in combination with rituximab has not been approved by the U.S. Food and Drug Administration (FDA) for treatment of FL. Approximately 105 patients with previously untreated FL have already received lenalidomide in combination with rituximab in clinical trials, and the early results show that it may be active against this disease. This study will compare the efficacy and safety of rituximab plus lenalidomide versus rituximab plus chemotherapy followed by rituximab to learn which works better for patients with FL. Investigator: Edward N. Libby, MD

Lung Cancer

MPDL3280A for PD-L1-Positive Locally Advanced or Metastic Non-Small Cell Lung Cancer

A Phase II, Multicenter, Single-Arm Study of MPDL3280A in Patients with PD-L1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer

MPDL3280A is an experimental immunotherapeutic drug for patients who have PD-L1-positive lung cancer. Not yet approved by the FDA, the trial will determine this drug’s safety and effi cacy. PD-L1, a monoclonal antibody that targets programmed cell death-1 ligand 1, will be administered with bevacizumab (Arm A) and with bevacizumab plus chemotherapy (Arm B). In Phase I studies, PD-L1 was well tolerated and effective against several cancers. Researchers presented the Phase I results at the American Society of Clinical Oncology meeting in June this year. Investigator: Laura Q.M. Chow, MD

Prostate Cancer

BKM120 for Metastic Castration-Resistant Prostate Cancer

Phase II Study of BKM120 in Men with Metastatic Castration-Resistant Prostate Cancer

The purpose of this Phase II study is to look at how BKM120, an inhibitor of a protein called phosphatidyl inositol-3-kinase (PI3K), works in treating men with prostate cancer. The protein is found in normal cells as well as cancer cells, but can be overactive in many cancer cells. In particular, very strong preclinical laboratory data shows that treatment with enzalutamide, an exciting new FDA-approved therapy, leads to this pathway activation. Therefore, adding BKM120 at the time of resistance to enzalutamide could induce responses again.

This study will see if stopping this protein will slow the growth of prostate cancer and will focus on patients currently starting to have progression on enzalutamide. Researchers will also investigate how cancer changes in response to BKM120 by studying DNA, RNA, and protein changes in circulating tumor cells. This is the first time this drug is being tested in men with prostate cancer. UW Medical Center, SCCA, Duke University Medical Center, and several other study centers associated with the Prostate Cancer Clinical Trials Consortium are conducting this study. Investigator: Evan Ya-Wen Yu, MD

Immune Monitoring of Sipuleucel-T

Immune Monitoring Protocol in Men with Prostate Cancer Enrolled in a Clinical Trial of Sipuleucel-T

This study is sponsored by Dendreon Corporation. It is not a treatment study but a registry study about sipuleucel-T, also called PROVENGE, an approved immunotherapy designed to stimulate immune response against prostate cancer. The main purpose of this study is to learn how the body’s immune system responds to treatment with sipuleucel-T. Patients will have blood drawn for immune monitoring before their fi rst leukapheresis for infusion of sipuleucel-T, and then at 6, 10, 14, 24, 39, and 52 weeks after. Researchers will perform several types of tests on the blood samples to potentially identify biomarkers or proteins that will predict the effectiveness of sipuleucel-T. Investigator: Celestia Higano, MD

Hotlist

NCI Designation

Disease Site

Description

NCT01439347

Acute Lymphoblastic Leukemia

A Phase III, Multicenter, Randomized Study to Evaluate the Substitution of Marqibo® (Vincristine Sulfate Liposomes Injection, VSLI) for Standard Vincristine Sulfate Injection (VSI) in the Induction, Intensification, and Maintenance Phases of Combination Chemotherapy in the Treatment of Subjects = 60 Years Old with Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)

NCT01807091

Acute Myeloid Leukemia

Feasibility of Outpatient Induction Chemotherapy for Adult Patients with Newly Diagnosed Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome

NCT01831232

Acute Myeloid Leukemia

Idarubicin, Cytarabine, and Pravastatin (IAP) for Induction of Newly Diagnosed Acute Myeloid Leukemia (AML)

NCT00626990

Anaplastic Glioma

Phase III Trial On Concurrent and Adjuvant Temozolomide Chemotherapy in Non-1P/19Q Deleted Anaplastic Glioma: The CATNON Intergroup Trial (RTOG 0834)

NCT01340976

Anemia and Cancer

A Phase I Safety Study of LY2787106 in Patients with Cancer Anemia

NCT01758484

Bone Marrow Transplant

Feasibility of Implementing Pre-Transplant Palliative Care Support for Patients Undergoing Hematopoietic Cell Transplantation for Hematological Malignancies

NCT01691248

Bone Marrow Transplant

DEFLECT-I: A Phase IIIb Multi-Center, Double-Blind, Randomized, Placebo Controlled Study to Demonstrate the Safety and Efficacy of Fidaxomicin for Prophylaxis Against Clostridium DifficilE-Associated Diarrhea in Adults Undergoing Hematopoietic Stem Cell Transplantation

NCT01650805

Chronic Myeloid Leukemia

A Phase III Randomized, Open-Label Study of Ponatinib versus Imatinib in Adult Patients with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase

NCT01515787

Colorectal Cancer

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

NCT01729923

Colorectal Cancer

A Phase II Trial of Maintenance ADAPT Therapy with Capecitabine and Celecoxib in Patients with Metastatic Colorectal Cancer

NCT01729923

Colorectal Cancer

A Phase II, Multicenter, Open-Label, Randomized Study Evaluating the Efficacy and Safety of Folfiri + Mehd7945a versus Folfiri + Cetuximab in Second Line in Patients with Kras Wild-Type Metastatic Colorectal Cancer

NCT01652482

Colorectal Cancer

A Phase IIA Open Label, Adaptive, Randomized Clinical Trial of Dalotuzumab (MK-0646) Treatment in Combination with Irinotecan Versus Cetuximab and Irinotecan for Patients with Metastatic Rectal Cancers (mRC) Expressing High IGF-1/Low IGF-2 Levels

NCT01468688

Gastrointestinal Stromal Tumor

A Multi-Arm Dose-Finding Phase Ib Multicenter Study of Imatinib in Combination with the Oral Phosphatidyl-Inositol 3-Kinase (PI3-K) Inhibitor BKM120 in Patients with Gastrointestinal Stromal Tumor (GIST) who Failed Prior Therapy with
Imatinib and Sunitinib

NCT00755040

Graft vs. Host Disease

A Randomized Placebo Controlled Double-Blind Study of Restasis® versus Placebo in Primary Prevention of Ocular GVHD after Allogeneic Stem Cell Transplantation

NCT01366092

Graft vs. Host Disease

A Phase II Trial of Daily Low-Dose Interleukin-2 (IL-2) for Steroid-Refractory Chronic Graft-versus-Host-Disease

NCT01091428

Gynecologic Cancer

Randomized Phase II Study of MLN8237, an Aurora A Kinase Inhibitor, Plus Weekly Paclitaxel or Weekly Paclitaxel Alone in Patients with Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer, Preceded by a Phase I Portion in Patients with Ovarian or Breast Cancer

NCT01620229

Hematologic Malignancies After BMT

Maintenance Therapy with Brentuximab Vedotin (SGN-35) after Allogeneic Hematopoietic Cell Transplantation for Hodgkin Lymphoma and CD30+ Hematologic Malignancies

NCT01336634

Lung Cancer

A Phase II Study of the Selective BRAF Kinase Inhibitor GSK2118436 in Subjects with Advanced Non-Small Cell Lung Cancer and BRAF Mutations

NCT01685060

Lung Cancer

A Phase II, Multicenter, Single-arm Study of Oral LDK378 in Adult Patients with ALK-activated Non-Small Cell Lung Cancer Previously Treated with Chemotherapy and Crizotinib

NCT01685138

Lung Cancer

A Phase II, Multicenter, Single-Arm Study of Oral LDK378 in Crizotinib Naïve Adult Patients with ALK-Activated Non-Small Cell Lung Cancer

NCT01846416

Lung Cancer

A Phase II, Multicenter, Single-Arm Study of MPDL3280A in Patients with PD-L1-Positive Locally Advanced or Metastatic
Non-Small Cell Lung Cancer

NCT01865617 Lymphoma

Phase I/II Study of Immunotherapy for Advanced CD19+ Chronic Lymphocytic Leukemia and Non-Hodgkin's Lymphoma with Defined Subsets of Autologous T Cells Engineered to Express a CD19-Specific Chimeric Antigen Receptor

NCT01727076

Melanoma, Renal Cell, Non-Small Cell Lung and
Head and Neck Cancer

A Phase I Study of Recombinant Human IL15 (rhIL15) in Adults with Advanced Solid Tumors: Melanoma, Renal Cell, Non-Small Cell Lung and Head and Neck Cancer

NCT01704287

 Melanoma

Randomized, Phase II Study of MK-3475 versus Chemotherapy in Patients with Advanced Melanoma

NCT01435720

Multiple Myeloma

A Phase I/II Open-Label, Multiple-Dose, Dose-Escalation Study to Evaluate the Safety and Tolerability of SNS01-T Administered by Intravenous Infusion in Patients with Relapsed or Refractory Multiple Myeloma, Mantle Cell Lymphoma, or Diffuse Large B Cell Lymphoma

NCT01478581

Multiple Myeloma

A Multicenter Phase II Study of the Bruton’s Tyrosine Kinase (Btk) Inhibitor, PCI-32765, in Subjects with Relapsed or Relapsed and Refractory Multiple Myeloma

NCT01812252

Myelodysplastic Syndrome/BMT

Initial Cytoreductive Therapy for Myelodysplastic Syndrome Prior to Allogeneic Hematopoietic Cell Transplantation (the ICT-HCT Study)

NCT011212640

Ovarian Cancer

A Randomized Controlled Trial Using Novel Markers to Predict Malignancy in Elevated-Risk Women (Novel Markers Trial)

NCT01839487

Pancreatic Cancer

A Phase II, Randomized, Multicenter Study of PEGPH20 (PEGylated Recombinant Human Hyaluronidase)Combined with Nab-Paclitaxel Plus Gemcitabine Compared with Nab-Paclitaxel Plus Gemcitabine in Subjects with Stage IV Previously Untreated Pancreatic Cancer

NCT01253642

Prostate Cancer

A Phase II Study of MAOA Inhibitor Plus Docetaxel in Patients Currently Receiving and Progressing on Docetaxel Therapy

NCT01703065

Prostate Cancer

A Pilot Study of the Effects of Cabozantinib (XL184) on Bone Turnover and Microenvironment in Men with Non-Metastatic and Metastatic Castration-Resistant Prostate Cancer

NCT01576172

Prostate Cancer

A Randomized Gene Fusion Stratified Phase II Trial Of Abiraterone with or without ABT-888 for Patients with Metastatic Castration-Resistant Prostate Cancer

NCT01283373

Prostate Cancer

A Phase I, Open-Label Study of the Safety and Pharmacokinetics of Escalating Doses of DSTP30862 in Patients with Metastatic Castration-Resistant Prostate Cancer

NCT01582672

Renal Cell Carcinoma

An International Phase III Randomized Trial of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (ADAPT)

NCT01668784

Renal Cell Carcinoma

A Randomized, Open-Label, Phase III Study of BMS-936558 versus Everolimus in Subjects with Advanced or Metastatic Clear-Cell Renal Cell Carcinoma who have Received Prior Anti-Angiogenic Therapy



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 Hutchinson Center 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.