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Clinical Trials Monthly - October 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 pancreatic cancer, melanoma, lymphoma, and prostate cancer.

Phase II Trial Gets Closer to Beating Pancreatic Cancer

Pancreatic cancer is unusually aggressive and unresponsive to chemotherapies. In 2012, Sunil R. Hingorani, MD, PhD and colleagues reported that pancreatic cancer’s fibroinflammatory response creates unusually high interstitial fluid pressures that collapse the tumor’s blood vessels, which in turn prevents chemotherapy agents from entering the tumors. They found that hyaluronic acid (HA) is the main biological cause of the elevated pressures, and when they administered PEGPH20, which specifically targets and degrades HA, in combination with gemcitabine, the tumor barrier is degraded, resulting in rapid reduction of the interstitial fluid pressure. This in turn opens the blood vessels and permits high concentrations of gemcitabine to reach the tumor.

Based on these preclinical studies, Hingorani, head of pancreatic cancer research at Seattle Cancer Care Alliance (SCCA) and associate member of the Clinical Research and Public Health Divisions at Fred Hutchinson Cancer Research Center, opened a Phase I trial to evaluate gemcitabine plus PEGPH20 compared to gemcitabine plus placebo in patients with previously untreated metastatic pancreatic ductal adenocarcinoma. Results from the Phase I study, reported at the American Society of Clinical Oncology meeting in June 2013, were promising and have led to launching this randomized Phase II trial with a larger cohort of patients. In this trial, half of the patients will get gemcitabine plus nab-paclitaxel and the other half will get the combination of the same chemotherapy with PEGPH20. The U.S. Food and Drug Administration (FDA) approved nab-paclitaxel this past summer for pancreatic cancer treatment.

"Targeting the protective tumor matrix with an enzyme that digests hyaluronan is a novel treatment strategy for solid tumors. In addition to enabling chemotherapy drugs to penetrate more effectively into the tumor, removing hyaluronan may also slow its growth," Hingorani said. "Pancreatic cancer is one of the most challenging cancers to treat. We are encouraged by this early stage clinical data and look forward to the results of ongoing randomized trials to test the potential of PEGPH20 in combination with the most active chemotherapies available for patients today."

Follicular Lymphoma

A Study of PCI-32765 (Ibrutinib) in Patients with Refractory Follicular Lymphoma

An Open-label, Multicenter, Single-arm, Phase II Study of PCI-32765 (Ibrutinib) in Subjects with Refractory Follicular Lymphoma (NCT01779791)

PCI 32765, also known as ibrutinib, is an experimental drug being tested as a non-Hodgkin’s lymphoma treatment. More than 500 patients have taken ibrutinib in 12 other studies. The main purpose of this study is to assess the effects of ibrutinib in follicular lymphoma patients. This drug is a Bruton’s tyrosine kinase (BTK) inhibitor that blocks an enzyme (protein) that affects how follicular lymphoma cells grow and survive. Blocking this enzyme is a very important mechanism in killing these cancer cells. As an experimental drug, ibrutinib is not approved by any regulatory authority in any country including the FDA; therefore, it can only be used in a research study such as this one. Investigator: Ajay K. Gopal, MD

Melanoma

Tumor-Infiltrating Lymphocytes (TIL) for Metastatic Melanoma (2643)

Cellular Adoptive Immunotherapy Using Autologous Tumor-Infiltrating Lymphocytes Following Lymphodepletion with Cyclophosphamide and Fludarabine for Patients with Metastatic Melanoma (NCT01807182)

Melanoma is one type of cancer that can be recognized and attacked by the immune system. Tumor-infiltrating lymphocytes (TIL) are a special type of lymphocyte found around and between cancer cells believed to be specifically able to recognize the cancer cells (as opposed to the lymphocytes that recognize bacteria or viruses). TIL therapy involves increasing the number of these cancer-fighting lymphocytes by taking them from the patient’s body, growing them into very large numbers in a laboratory, and infusing them back into the patient to try to control the cancer. TIL therapy has been studied in patients with metastatic melanoma at the National Institutes of Health and MD Anderson with excellent results in some patients. However, melanoma researchers do not yet know why some patients respond to TIL therapy and some do not. The purpose of this study is to treat melanoma patients with TIL therapy, evaluate its efficacy, and investigate which characteristics and features of the patient’s melanoma correlate with a response (or lack of response) to the treatment. Investigator: Silvia M. Lee, MD

Pancreatic Cancer

PEGPH20 for Stage IV Untreated Pancreatic Cancer (2687)

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 (NCT01839487)

This study will determine the safety and effect of treatment with PEGPH20 combined with nab-paclitaxel and gemcitabine (PAG) to nab-paclitaxel and gemcitabine (AG) in subjects with stage IV pancreatic cancer. Investigator: Sunil R. Hingorani, MD

Prostate Cancer

Abiraterone Acetate for Metastatic Hormone-Resistant Prostate Cancer (7639)

Open Label Pharmacodynamic Study of Abiraterone in the Treatment of Metastatic, Castration Resistant Prostate Cancer (NCT01503229)

This study will examine a new drug called abiraterone acetate (Zytiga) to determine how it affects the chemistry of cancer tissue. SCCA researchers hope to learn the best way to use this drug and to see how to prevent prostate cancer from becoming resistant. Participants will provide samples of their cancer tumor(s) in three groupings. Groups will be assigned after screening and are not random but based on time of enrollment. The FDA has approved abiraterone acetate for metastatic castration resistant prostate cancer before or after treatment with chemotherapy. The approved dose is 1,000 mg per day. Using abiraterone at a dose higher than 1,000 mg per day is research. All of the groups will receive the same treatment, abiraterone acetate plus prednisone. The difference across the groups is when tissue samples are taken. Investigator: Robert Bruce Montgomery, MD


Hotlist

NCI Designation

Disease Site

Description

NCT01872819

Acute Myeloid Leukemia

Treatment for Relapsed/Refractory AML 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

NCT01848834

Advanced Triple Negative Breast Cancer, Advanced Head and Neck Cancer, or Advanced Urothelial Cancer

A Phase Ib Multi-Cohort Study of MK-3475 in Subjects With Advanced Solid Tumors

NCT01353222

Bladder Cancer

A Randomized, Phase II, Open-label Study Evaluating DN24-02 as Adjuvant Therapy in Subjects with High Risk HER2+ Urothelial Carcinoma

7754

Brain Tumors

Cellular Proliferation Using [18F] Fluorothymidine (FLT) Positron Emission Tomography (PET) in Brain Tumors

NCT01872975

Breast Cancer

A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy

NCT01723943

Breast Cancer, for Spouses of

Psychoeducation for Spouses of Women With Breast Cancer (Helping Her Heal)

NCT01547741

Breast Cancer

A Phase III Clinical Trial Comparing the Combination of Docetaxel Plus Cyclophosphamide to Anthracycline-Based Chemotherapy Regimens for Women with Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer

NCT01922921

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

NCT01101451

Cervical Cancer

Randomized Phase III Clinical Trial of Adjuvant Radiation versus Chemoradiation in Intermediate Risk, Stage I/IIA Cervical Cancer Treated with Initial Radical Hysterectomy and Pelvic Lymphadenectomy

NCT00916409

Glioblastoma

A Prospective, MultiCenter Trial of NovoTTF-100A Together with Temozolomide Compared to Temozolomide Alone in Patients with Newly Diagnosed GBM

NCT01730950

Glioblastoma

Randomized Phase II Trial of Concurrent Bevacizumab and Re-Irradiation versus Bevacizumab Alone as Treatment for Recurrent Glioblastoma

NCT01266031

Glioblastoma

Phase I/II Adaptive Randomized Trial of Bevacizumab versus Bevacizumab Plus Vorinostat in Adults with Recurrent Glioblastoma

NCT01556490

Hepatocellular Carcinoma

A Phase III Clinical Trial of Intra-Arterial TheraSphere in the Treatment of Patient with Unresectable Hepatocellular Carcinoma (HCC)

NCT01779791

Lymphoma

An Open-Label, Multicenter, Single-Arm, Phase II Study of PCI-32765 (Ibrutinib) in Subjects with Refractory Follicular Lymphoma

NCT01807182

Melanoma

Cellular Adoptive Immunotherapy Using Autologous Tumor-Infiltrating Lymphocytes Following Lymphodepletion with Cyclophosphamide and Fludarabine for Patients with Metastatic Melanoma

NCT01566695

Myelodysplastic/Myleofroliferative Syndromes

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

NCT01691898

Non-Hodgkin's Lymphoma

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

NCT01853306

Ovarian Cancer, BRCA Mutated Breast Cancer

A Phase I Study to Evaluate the Safety, Pharmacokinetics and Oral Bioavailability of Veliparib in Subjects with Solid Tumors

NCT01716715

Ovarian, Fallopian Tube, Peritoneal Cancers

A Randomized Phase I Study of NCI Supplied Cabozantinib (Nsc #761968 Ind #116059) versus Weekly Paclitaxel (Nsc #673089) in the Treatment Of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

NCT01072981

Pancreatic Cancer

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

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

NCT01647789

Prostate Cancer

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

NCT01790126

Prostate Cancer

The Role of Highly Selective Androgen Receptor (AR) Targeted Therapy in Men with Biochemically Relapsed Hormone Sensitive Prostate Cancer

NCT01709734

Prostate Cancer

ARMOR2: A 2 Part, Phase II Trial of Galeterone in the Treatment of Castration-Resistant Prostate Cancer

NCT01718353

Prostate Cancer

Phase II Trial to Evaluate Benefit of Early Switch From First-Line Docetaxel/Prednisone to Cabazitaxel/Prednisone and the Opposite Sequence, Exploring Molecular Markers and Mechanisms of Taxane Resistance in Men with Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Have Not Received Prior Chemotherapy

NCT01685268

Prostate Cancer

A Study of HSP90 Inhibitor AT13387 Alone or in Combination with Abiraterone Acetate in the Treatment of Castration-Resistant Prostate Cancer (CRPC) no Longer Responding to Abiraterone

NCT01799278

Prostate Cancer

A Phase II Trial of the Aurora Kinase A Inhibitor MLN8237 in Patients with Metastatic Castrate Resistant and Neuroendocrine Prostate Cancer

NCT01884285

Prostate, Lung, Breast Cancer

A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-Tumour Activity of Ascending Doses of AZD8186 in Patients with Advanced Castrate-Resistant Prostate Cancer (CRPC), Squamous Non-Small Cell Lung Cancer (sqNSCLC), Triple Negative Breast Cancer (TNBC) and Patients with Known PTEN-Deficient Advanced Solid Malignancies, with Expansion to Assess the Pharmacodynamic Activity of AZD8186 within Prospectively-validated PTEN Deficient Tumours


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.