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Clinical Trials Monthly - September 2013

Clinical trials help us increase our knowledge about cancer and develop more effective, less toxic treatments. 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 share our new trials for breast cancer, lymphoma, and immunotheraphy for pancreatic cancer.

Treating Pancreatic Cancer with Immunotherapy

Despite the best clinical efforts and breakthroughs in biotechnology, most pancreatic cancer patients continue to die from the rapid progression of their disease. One reason for the high mortality rate is lack of symptoms until significant local and/or distant spread has occurred. Another reason is the lack of treatment options to substantially increase long-term survival.

Scientists have clearly shown that pancreatic tumor cells produce a number of defective proteins, or express normal proteins in highly uncharacteristic ways. In some cancers, these abnormalities can cause an immune response to the cancer cells. In progressive cancers however, the immune system fails to effectively identify or respond to these abnormalities and the cancer cells are not attacked or destroyed for reasons not yet fully understood.

A new clinical trial at Seattle Cancer Care Alliance (SCCA) proposes a way to stimulate the immune system to recognize pancreatic cancer cells and to stimulate an immune response that destroys or blocks the growth of the cancer. HyperAcute® pancreas immunotherapy tries to harness the hyperacute rejection response to teach a patient’s immune system to fight their pancreatic cancer. HyperAcute pancreas immunotherapy contains human pancreatic cancer cells with a mouse gene that marks the cancer cells as foreign to a patient’s immune system. The immune system therefore attacks these cancer cells just as it would attack any truly foreign tissue, destroying as much as it can. The immune system is also stimulated to identify differences (aside from the mouse gene) between these cancer cells and normal human tissue as foreign. This “education” of the immune system helps treat the patient because pancreatic cancer cells already present in a treated patient are believed to show some of the same differences from normal tissue as the modified pancreatic cancer cells in the product. Due to these similarities, the immune system, once “educated” by the HyperAcute pancreas immunotherapy, identifies the patient’s cancer cells as foreign and attacks them. Learn more about this trial.

Breast Cancer

Vaccine Therapy and Trastuzamab with/without Polysaccharide-K for Stage IV HER2 Positive Breast Cancer

Phase I/II Randomized Study of Combination Immunotherapy with or without Polysaccharide Krestin (PSK®) Concurrently with a HER2 ICD Peptide-Based Vaccine and Trastuzumab in Patients with Stage IV Breast Cancer (NCT01922921)

A natural mushroom product known as polysaccharide krestin (PSK) has been used in traditional medicine in China, Japan, and other Asian countries for centuries. PSK has been shown to stimulate “natural killer” (NK) cells in the immune system. Breast cancer patients have low levels of NK cells, and randomized clinical trials with PSK have shown a low toxicity profile and improved survival in breast cancer patients. The primary purpose of this study is to determine the safety of giving PSK with the HER2 vaccine and Herceptin because this combination has never been studied. In addition, researchers will investigate whether PSK increases the amount or activity of NK cells in the bloodstream and if PSK helps produce stronger HER2 immune responses. Investigators hypothesize that the use of PSK will augment the innate anti-tumor immune responses. Additionally, PSK could potentially augment HER2 vaccine-induced immunity and collectively the combination therapy could result in enhanced eradication of micrometastatic disease, which could prevent relapse in patients with optimally treated HER2+ stage IV breast cancer. Investigator: Lupe G. Salazar, MD

Lymphoma

TREC for Relapsed or Refractory Lymphoid Malignancies

A Phase I/II Study of Bendamustine/Treanda, Rituximab, Etoposide, and Carboplatin for Patients with Relapsed or Refractory Lymphoid Malignancies and Select Untreated Lymphomas (NCT01165112)

Bendamustine is a new drug approved by the U.S. Food and Drug Administration for the treatment of certain types of non-Hodgkin’s lymphoma. In this study, we will treat different types of lymphoid malignancies (B-cell lymphoma, T-cell lymphoma or Hodgkin’s lymphoma) and give bendamustine in combination with standard therapy of etoposide, carboplatin, and rituximab therapy to learn what effects this will have on patients with these lymphoid malignancies, watching carefully for any side effects. This trial will also determine the ability to collect peripheral blood stem cells in patients where this procedure is planned after this treatment. Investigator: Ajay K. Gopal, MD

DCDT2980S or DCDS4501A in Combination with MabThera/Rituxan for Relapsed Lymphoma (FH 2649)

A Randomized, Open-Label, Multicenter, Phase II Trial Evaluating the Safety and Activity of DCDT2980S in Combination with Rituximab or DCDS4501A in Combination with Rituximab in Patients with Relapsed or Refractory B-Cell Non-Hodgkin’s Lymphoma (NCT01691898)

This study will test two experimental drugs called DCDT2980S and DCDS4501A, each in combination with rituximab (Rituxan, MabThera) to determine the effects these drugs have on patients and their cancer. Manufactured by Genentech, DCDT2980S and DCDS4501A are designed to inhibit tumor growth, targeting specific tumor markers: DCDT2980S a molecule called CD22 (CD22 antigen), and DCDS4501A a molecule called CD79b (CD79b antigen). In laboratory experiments and in animal studies, both reduced the growth of a number of B-cell malignancies including lymphomas. Investigator: Oliver W. Press, MD, PhD

Pancreatic Cancer

FOLFIRINOX with or without HyperAcute® Pancreas Immunotherapy for Pancreatic Cancer (8028)

A Phase III Study of FOLFIRINOX with or without HyperAcute® Pancreas (algenpantucel-L) Immunotherapy in Subjects with Borderline Resectable or Locally Advanced Unresectable Pancreatic Cancer (NCT01836432)

In this study, patients receive a strong combination of anti-tumor chemotherapies while some patients are also given injections of an immunotherapy drug consisting of two types of pancreatic cancer cells modified to make them more easily recognizable to be attacked by the immune system. This new treatment protocol may increase the time until the tumor progresses or increase overall survival when given in combination with the current standard-of-care therapy, FOLFIRINOX, which has been shown to improve survival in advanced pancreatic cancer. One goal of this study is to determine whether chemotherapy and immunotherapies can work cooperatively to increase anti-tumor effects to levels beyond what would be seen with either treatment alone. Investigator: Andrew L. Coveler, MD

Hotlist

NCI Designation

Disease Site

Description

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)

NCT01872819

Acute Myeloid Leukemia

Treatment for Relapsed/Refractory Acute Myeloid Leukemia Based on a High Throughput Drug Sensitivity Assay

NCT01902329

Acute Myeloid Leukemia

A Phase I Trial of SGN-CD33A in Patients with CD33-Positive Acute Myeloid Leukemia

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

NCT01652482

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

NCT01609231

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

NCT01498328

Glioblastoma

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

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

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

NCT01566695

Myelodysplastic Syndrome

A Phase III, Multicenter, Randomized, Double-blind Study to Compare the Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care versus Placebo Plus Best Supportive Care in Subjects with Red Blood Cell Transfusion-dependent Anemia and Thrombocytopenia Due to IPSS Lower-risk Myelodysplastic Syndromes

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)

NCT01836432

Pancreatic Cancer

A Phase III Study Of FOLFIRINOX with or without Hyperacute®-Pancreas (algenpantucel-L) Immunotherapy in Subjects with Borderline Resectable or Locally Advanced Unresectable Pancreatic Cancer

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

NCT01072981

Pancreatic Cancer

A Phase III Study of Chemotherapy and Chemoradiotherapy with or without HyperAcute®-Pancreatic Cancer Vaccine in Subjects with Surgically Resected Pancreatic 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

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

NCT01647789

Prostate Cancer

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

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

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)



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.