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Clinical Trials Monthly - July 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 AML or MDS, leukemia, lymphoma, and rectal cancer.

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Treating “Unfit” Patients with AML or High-Risk MDS

Intensive, multi-agent chemotherapy benefits many patients with a new diagnosis of acute myeloid leukemia (AML). However, such therapies are associated with significant treatment-related morbidity and mortality in medically unfit patients, which are often of older age and have more difficult-to-treat forms of AML. Recently, CPX-351, a liposomal formulation of two standard AML drugs (cytarabine and daunorubicin) has entered clinical testing. In initial studies, doctors found that CPX-351 reduced early mortality among intensively treated, newly diagnosed older patients while retaining the same overall response rates. More importantly, in another trial in patients with relapsed or refractory AML, complete responses were achieved at dose levels well below the maximum tolerated dose, resulting in a net improvement in survival among high-risk AML patients, most notably in patients with secondary disease. The latter observation provides the direct rationale to test lower doses in more fragile patients.

“The need for effective treatment for medically unfit patients with AML or high-risk MDS is unquestioned,” said Roland B. Walter, MD, PhD, assistant member at Fred Hutchinson Cancer Research Center and professor of medicine at the UW School of Medicine, who enrolled the first patient in this trial. “Many of these individuals–or the elderly patients more generally–are often excluded from curative-intent or even lower-intensity therapy, although the potential benefit of disease-directed therapy is well established. This trial, which will evaluate two different doses of CPX-351 in a controlled fashion, provides an exciting opportunity to test a novel therapy in a patient population that is often neglected in the typical AML trial.”


Liposomal Cytarabine-Daunorubicin CPX-351 for Untreated Myelodysplastic Syndrome or 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 (NCT01804101)

CPX-351, a liposome injection formulated with a synergistic 5:1 molar ratio of cytarabine and daunorubicin, two agents commonly used to treat hematologic malignancies, is a potentially useful therapy in acute myeloid leukemia (AML) patients at high risk of treatment-related mortality.

Based on observations from initial early phase clinical trials, CPX-351 may reduce early mortality among newly diagnosed older patients with the same complete remission rate as standard therapy, resulting in somewhat improved survival. Using reduced dose levels of only 1/3 and 2/3 of the maximum tolerated dose (MTD) in patients with newly diagnosed AML considered “unfit” for standard induction chemotherapy, it is hoped that CPX-351 may provide a similar response rate as was observed in the Phase I study with a lower risk of serious treatment-related toxicities. CPX-351 seems to maintain activity better in patients whose disease tends to be resistant to standard therapy. For example, those with short first remissions and/or secondary AML, than conventional chemotherapeutics. Such characteristics are disproportionately common among older patients, who will form the majority of the patients entered in this trial. Investigator: Roland B. Walter, MD, PhD


Inotuzamab Ozogamicin for Acute Lymphocytic Leukemia

An Open-Label, Phase I/II Study of Inotuzumab Ozogamicin in Subjects with Relapsed or Refractory CD22-Positive Acute Lymphocytic Leukemia (NCT01363297)

The purpose of this research study is to learn about the effects of inotuzumab ozogamicin as a treatment for acute lymphocytic leukemia (ALL). This study will test different doses of the drug to find the best dose for treating ALL. Physician researchers will examine the safety and side effects of the study drug. Inotuzumab ozogamicin is a new investigational drug that the U.S. Food and Drug Administration (FDA) has not yet approved. Investigator: Andrei Shustov, MD


Brentuximab Vedotin for Relapsed or Refractory CD30+ Lymphoma

A Pilot Study of Weekly Brentuximab Vedotin in Patients with CD30+ Malignancies Refractory to Every > = 3 Week Brentuximab Vedotin (NCT01703949)

Brentuximab vedotin (Adcetris) is an FDA-approved antibody drug conjugate (ADC). The antibody portion sticks to a target called CD30, which is found on some cancer cells and some normal cells of the immune system. The chemotherapy part, called monomethyl auristatin E (MMAE), can kill the cells that the antibody part sticks to. This study looks at giving brentuximab vedotin more frequently at a lower dose—an experimental schedule and dosage not approved by the FDA. A previous study determined the recommended dosage for this experimental schedule. This ADC is still being studied in clinical trials to learn more about its side effects and whether it is effective in the disease or condition being studied. Investigator: Ajay K. Gopal, MD

Rectal Cancer

Chemotherapy or Chemotherapy + Radiation for Rectal Cancer Patients Undergoing Surgery

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) plus a selective use of 5FUCMT, depending on response to the FOLFOX. The drugs used in the FOLFOX regimen are all FDA approved and have been used routinely since 2002 to treat patients with advanced colorectal cancer. Investigator: Alessandro Fichera, MD and Veena Shankaran, MD


NCI Designation

Disease Site



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)


Acute Myeloid Leukemia

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


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


Acute Myeloid Leukemia

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


Acute Myeloid Leukemia

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


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


Anaplastic Glioma

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


Bone Marrow Transplant

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


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


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


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


Colorectal Cancer

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


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


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



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


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


Graft vs. Host Disease

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



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



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


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


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


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

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



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


Myelodysplastic Syndrome/BMT

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


Ovarian Cancer

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


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


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


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


Prostate Cancer

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


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


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


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


Prostate Cancer

A Phase I/II, Multicenter, Open-Label Dose Finding Study of Oral CFG920 in Patients with Metastatic Castration-Resistant Prostate Cancer


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


Prostate Cancer

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


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


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.