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Clinical Trials Monthly - June 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 feature trials for lung cancer and lymphoma.

Subscribe to the SCCA Blog for the latest video interviews with our physicians and news about clinical trials at www.sccablog.org. Or, follow SCCA’s clinical trials Twitter feed at www.twitter.com/SCCA_Trials for the most up-to-date announcements of newly opened trials.

This Month's Clinical Trials:

Lung Cancer

Non-Hodgkin's Lymphoma

Genetic Sequencing, Targeting Mutations, The Future of Lung Cancer Research

Seattle Cancer Care Alliance (SCCA) is one of only 11 thoracic oncology programs in the United States chosen to participate in a Phase II study of the selective BRAF kinase inhibitor GSK2118436 in subjects with advanced non-small cell lung cancer (NSCLC) and BRAF mutations. Mutations in the BRAF gene, which codes for a protein involved in intracellular signaling, have been implicated in several human cancers.

Medical oncologists from the SCCA Thoracic, Head & Neck Oncology Program routinely perform genetic sequencing with UW-OncoPlex, a diagnostic tool developed at the University of Washington to test tumor tissue for the presence of nearly 200 specific driver mutations.

Because of UW-Oncoplex, “we are able to prospectively identify who will be eligible for this trial and efficiently pair the right patients with the right trials,” said Sarah Wallace, clinical trials program manager for the SCCA thoracic oncology group.

This is the fi rst of many early development trials for patients identified using UW-Oncoplex as having rare genetic mutations. “Now that we can test these patients, we are able to identify which mutations are prevalent in our patient population,” Wallace said. “We will be able to go out and actively partner with sponsors to bring the optimal trials to our center. That’s a win for us and our patients.”

The study, titled: A Phase II Study of the Selective BRAF Kinase Inhibitor GSK2118436 in Subjects with Advanced Non-Small Cell Lung Cancer and BRAF Mutations, will test the investigational targeted drug, GSK2118436 (dabrafenib), to see how well it works in treating patients with NSCLC who have tested positive for BRAF. Click here for more information on this study.


Lung Cancer
 

LDK378 for Previously Treated ALK-Activated NSCLC (UW12038)

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 (NCT01685060)

LDK378 is an investigational selective inhibitor of anaplastic lymphoma kinase (ALK), which is a target found in many cancers including metastatic non-small cell lung cancer (NSCLC). In March 2013, the FDA designated LDK378 as a “Breakthrough Therapy” based on positive data from a Phase I trial of NSCLC patients previously treated with crizotinib. This special designation is intended to expedite development and review of extremely promising drugs, like LDK378 that show substantial improvement over standard therapy for a serious or life-threatening condition.

Patients with ALK+ NSCLC tend to be nonsmokers and younger than NSCLC patients without the ALK trait. LDK378 is a daily oral medication. For this study 137 subjects from nearly 25 centers around the world will participate. To enroll, patients must be positive for the ALK gene rearrangement as documented in a special FISH assay. Investigator: Renato Martins, MD, MPH
 

LDK378 for Crizotinib-Naïve Patients with ALK-Activated NSCLC (UW12039)

A Phase II, Multicenter, Single-Arm Study of Oral LDK378 in Crizotinib Naïve Adult Patients with ALK-Activated Non-Small Cell Lung Cancer (NCT01685138)

In this study, LDK378 is given to patients with ALK+NSCLC who have not received treatment with crizotinib. In addition to testing the patient’s tumor sample to confirm their ALK status, if not documented already, a separate biomarker study will help determine what effect the drug has on the patient’s cancer. Levels of multiple genes and proteins in the tumor samples will be measured. In addition, using UW Medicine’s new test called UW-Oncoplex, researchers will sequence the ALK gene in the tumor samples to try to understand which patients respond best to LDK378 and why LDK378 stops working. Investigator: Renato Martins, MD, MPH

Lymphoma
 

Brentuximab Vedotin for Non-Hodgkin's Lymphoma (UW11026)

A Phase II Study of Brentuximab Vedotin in Relapsed or Refractory CD30-Positive Non-Hodgkin’s Lymphoma (NHL) (NCT01421667)

This trial will examine the efficacy and side effects of brentuximab vedotin, an antibody conjugated with the chemotherapy monomethyl auristatin E (MMAE) for non-Hodgkin’s lymphoma. Brentuximab is approved by the FDA for certain diseases, but not yet for non-Hodgkin’s lymphoma. This study will measure the drug’s anti-cancer effects as well as unwanted side effects. The drug will also be given in combination with rituximab to patients with diffuse large B-cell lymphoma to determine efficacy and side effects. Investigator: Andrei Shustov, MD
 

Alisertib (MLN8237) for Relapsed/Refractory Peripheral T-Cell Lymphoma (UW12009)

A Phase III, Randomized, Two-Arm, Open-Label, Multicenter, International Trial of Alisertib (MLN8237) or Investigator’s Choice (Selected Single Agent) in Patients with Relapsed or Refractory Peripheral T-Cell Lymphoma (NCT01482962)

In this study, the investigational drug, alisertib (MLN8237), or one of three other drugs, (pralatrexate, romidepsin, or gemcitabine) will be used to treat peripheral T-cell lymphoma (PTCL). Alisertib blocks the Aurora A kinase, interfering with cell division, slowing the cancer’s growth, and eventually causing cancer cell death. Alisertib has not been approved by the FDA for any use and is being studied with advanced solid tumor cancers as well as hematological cancers. Pralatrexate and romidepsin are approved PTCL treatments in patients with disease progression following at least one prior treatment. Gemcitabine is widely used to treat various cancers, including PTCL, although it is not FDA-approved for PTCL treatment. Patients who have previously received pralatrexate, romidepsin, and gemcitabine, whether combined with other drugs or alone, are not eligible for this study. Patients who previously received one or two of these drugs in the past will not be eligible to receive those specific drug(s) again in this study. Investigator: Andrei Shustov, 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

NCT01804101

Acute Myeloid Leukemia

Liposomal Cytarabine and Daunorubicin (CPX-351) for Adults with Untreated High-Risk MDS and Non-APL AML at High Risk of Treatment-Related Mortality

NCT01831232

Acute Myeloid Leukemia

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

NCT01756677

Acute Myeloid Leukemia

A Phase I/II Study of Low-Dose Cytarabine and Lintuzumab-Ac225 in Older Patients with Untreated Acute Myeloid Leukemia

NCT01696084

Acute Myeloid Leukemia

Phase III, Multicenter, Randomized, Trial of CPX-351 (Cytarabine: Daunorubicin) Liposome Injection Versus Cytarabine and Daunorubicin in Patients 60-75Yyears of Age with Untreated High Risk (secondary) 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)

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

NCT01650805

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

NCT01498328

Glioblastoma

A Phase II Study of Rindopepimut/GM-CSF in Patients with Relapsed EGFRvIII-Positive Glioblastoma

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

GYN

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

NCT01632852

Leukemia

A Phase I Study of CSL362 (Anti-IL3Ra / Anti-CD123 Monoclonal Antibody) in Patients with CD123+ Acute Myeloid Leukemia in Complete Remission or Complete Remission with Incomplete Platelet Recovery at High Risk for Early Relapse

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

NCT01704287

 Melanoma

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

NCT01812252

Myelodysplastic Syndrome/BMT

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

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

NCT01727076

Phase I

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

NCT01468688

Phase I

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

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

NCT01664923

Prostate Cancer

A Multicenter Phase II, Randomized, Double-Blind, Efficacy and Safety Study of Enzalutamide versus Bicalutamide in Men with Prostate Cancer who have Failed Primary Androgen Deprivation Therapy

NCT01647789

Prostate Cancer

A Phase I/II, Multicenter, Open-Label Dose Finding Study of Oral CFG920 in 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

NCT01106352

Prostate Cancer

A PhaseI/IIa Study of Safety and Efficacy of Alpharadin® with Docetaxel in Patients with Bone Metastases from Castration-Resistant Prostate Cancer

NCT01667536

Prostate Cancer

A Phase II Assessment of the Diagnostic Accuracy of Tc-MIP-1404 Imaging in Men with High-Risk Prostate Cancer Scheduled for Radical Prostatectomy and Extended Pelvic Lymph Node Dissection Compared to Histopathology

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 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.