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Clinical Trials Monthly - February 2014

The knowledge we gain from clinical trials helps develop more effective, less toxic cancer 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. 

Comparing Hypomethylating Therapy with Induction-Type Chemotherapy for High-Risk MDS/Candidates for Transplantation

Hypomethylating therapy (with azacitidine or decitabine) is standard management for patients with myelodysplastic syndrome (MDS) and for those with more advanced disease. Many studies have shown that, on average, patients gain nine to 10 months in life expectancy with azacitidine treatment. However, this approach is non-curative, and complete remission is achieved in less than 20 percent of patients.

Induction-type chemotherapy may achieve complete remission in approximately 60 percent of patients, but toxicity can be considerable, and remissions are short. Many of these patients eventually need a stem cell transplant, currently the only modality with curative potential.

Retrospective analyses suggest similar outcomes with a subsequent transplant in patients treated with either hypomethylating therapy or with induction chemotherapy. However, selection bias affects interpretation of those studies. Therefore, Seattle Cancer Care Alliance (SCCA) is conducting a study in which randomized patients with MDS (fi ve to 20 percent bone marrow myeloblasts) receive either hypomethylating therapy or induction-type chemotherapy in an effort to decrease disease burden in preparation for transplantation. This study’s objectives are to determine what proportion of patients make it to transplantation and which treatment offers better post-transplant survival.

This study is open to all patients with MDS (five to 20 percent bone marrow myeloblasts) who have not yet received hypomethylating therapy or induction-type chemotherapy. Patients will be randomized and referring providers will continue to provide care if desired. Community providers can administer the treatment; this protocol does not require that SCCA deliver the treatment. Learn More about this study

Acute Myeloid Leukemia

High Throughput Drug Sensitivity Assay for Selecting Treatment for Relapsed/Refractory AML

Treatment for Relapsed/Refractory AML Based on a High Throughput Drug Sensitivity Assay (NCT01872819)

This study will examine personalized drug testing to determine treatment for acute myeloid leukemia patients. Using a high throughput screen (HTS), researchers will take a patient’s leukemia cells and test them against each of the 160 drugs known to kill leukemia cells. The goal is to learn if this test can help determine which drug to choose to treat an individual’s leukemia. If a compatible drug is selected, the patient will receive treatment with that drug. Investigator: Pamela Becker, MD, PhD

Bladder Cancer

Sirolimus + Cisplatin/Gemcitabine for Bladder Cancer

A Phase I-II Study of Rapamycin (Sirolimus) and Cisplatin/Gemcitabine for Treatment of Patients with Bladder Cancer (NCT01938573)

This study will examine the response of bladder cancer to a new drug, rapamycin (Sirolimus), with standard chemotherapy treatment. The U.S. Food & Drug Administration (FDA) approved rapamycin, however, not for use in bladder cancer yet. Phase I will determine how much rapamycin can be safely given with gemcitabine and cisplatin. Phase II will carefully monitor for side effects when patients receive the determined doses with gemcitabine and cisplatin. Investigators: Jonathan Wright, MD, MS, FACS and Bruce Montgomery, MD

Glioblastoma

Novocure TTF Fields For Newly Diagnosed Glioblastoma

A Prospective, Multicenter Trial of NovoTTF-100A Together with Temozolomide Compared to Temozolomide Alone in Patients with Newly Diagnosed GBM (NCT00916409)

This study is a prospective, randomly controlled pivotal trial designed to test the efficacy and safety of a medical device, the NovoTTF-100A, as an adjuvant to the best standard of care in the treatment of newly diagnosed glioblastoma (GBM) patients. The device is an experimental, portable, battery-operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays. The hypothesis of this study is that adding NovoTTF-100A treatment to maintenance Temozolomide will significantly increase progression-free survival of newly diagnosed GBM patients compared to patients treated with Temozolomide alone. Investigator: Maciej Mrugala, MD, PhD, MPH

Prostate Cancer

MLN8237 for Metastatic Castrate Resistant and Neuroendocrine Prostate Cancer

A Phase II Trial of the Aurora Kinase A Inhibitor MLN8237 in Patients with Metastatic Castrate Resistant and Neuroendocrine Prostate Cancer (NCT01799278)

This study will examine the effects of MLN8237 (alisertib) on prostate cancer. Researchers want to know if the cancer shrinks, how long it remains in control, how long until it is no longer under control, and if the cancer has markers that may predict response to the study drug. Researchers will perform extensive analysis on the cancer’s genes to determine these answers. MLN8237 is a new drug that interferes with cell division and blocks Aurora kinase A, an enzyme that controls the distribution of new chromosomes into new cells, which may slow cancer growth and cause cancer cell death. This may be particularly effective in patients with neuroendocrine prostate cancer because it is believed that Aurora kinase A may have a role in the progression of this type of cancer. Investigator: Bruce Montgomery, MD

Hotlist

NCI Designation

Disease Site

Description

NCT01773785

Biliary Cancer

Phase II Study of SPI-1620 in Combination with Docetaxel as a Second-Line Treatment for Patients with Advanced Biliary Cancer

NCT01938573

Bladder Cancer

A Phase I-II Study of Rapamycin (Sirolimus) and Cisplatin/Gemcitabine for Treatment of Patients with Bladder Cancer

NCT01740427

Breast Cancer

A Randomized, Multicenter, Double-Blind, Phase III Study Of PD-0332991 (Oral CDK 4/6 Inhibitor) plus Letrozole versus Placebo plus Letrozole for the Treatment of Postmenopausal Women with ER (+), HER2 (-) Breast Cancer Who Have Not Received Any Prior Systemic Anti-Cancer Treatment For Advanced Disease

NCT01196936

Breast Cancer

Low-Dose Tamoxifen for Radiation-Induced Breast Cancer Risk Reduction: A Phase IIB Randomized Placebo-Controlled Trial

NCT01276704

Breast Cancer

Flaxseed Lignan as a Prevention Strategy for Pre-Menopausal Women at High Risk for Development of Breast Cancer

NCT02022579

Breast Cancer

ACRIN 6702: A Multicenter Study Evaluating the Utility of Diffusion Weighted Imaging for Detection and Diagnosis of Breast Cancer

NCT01969643

Breast Cancer, Phase I

A Phase I, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability of SGN-LIV1A in Patients with LIV-1-Positive Metastatic Breast Cancer

NCT01765582

Colorectal Cancer

STEAM: (Sequential Triplet And Avastin Maintenance): Folfoxiri/Bevacizumab Regimens (Concurrent and Sequential) vs. Folfox/Bevacizumab in First-Line Metastatic Colorectal Cancer

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

NCT01790503

Glioblastoma

An Open-Label Phase Ib/II Study of Orally Administered PLX3397 in Combination with Radiation Therapy and Temozolomide in Patients with Newly Diagnosed Glioblastoma

NCT01755767

Liver Cancer

A Phase III, Randomized, Double-Blind Study of Tivantinib (ARQ 197) in Subjects with MET Diagnostic-High Inoperable Hepatocellular Carcinoma Treated with One Prior Systemic Therapy

NCT01947608

Lung Cancer

An Open-Label, Multicenter, Expanded Treatment Protocol (ETP) of Oral LDK378 in Adult Patients with Non-Small Cell Lung Cancer (NSCLC) Characterized by ALK Positivity

NCT01982123

Lung Cancer

Pulmonary Functional Imaging for Radiation Treatment Planning for Lung Cancer

NCT01728805

Lymphoma

Open-Label, Multicenter, Randomized Study of Anti-CCR4 Monoclonal Antibody KW-0761 (Mogamulizumab) versus Vorinostat in Subjects with Previously Treated Cutaneous T-Cell LymphomaOpen-Label, Multicenter, Randomized Study of Anti-CCR4 Monoclonal Antibody KW-0761 (Mogamulizumab) versus Vorinostat in Subjects with Previously Treated Cutaneous T-Cell Lymphoma

NCT01359592

Lymphoma

A Phase II Trial of PET-Directed Therapy for Limited Stage Diffuse Large B-Cell Lymphoma (DLBCL)

NCT01495988

Melanoma

A Randomized Phase II Trial of Vemurafenib (PLX4032/RG7204) with or without Bevacizumab in Patients with Stage IV BrafV600 Mutant Melanoma

NCT01682083

Melanoma

COMBI-AD: A Phase III Randomized Double-Blind Study of Dabrafenib (GSK2118436) in CombInation with Trametinib (GSK1120212) versus Two Placebos in the Adjuvant Treatment of High-Risk BRAF V600 Mutation-Positive Melanoma After Surgical Resection

NCT01844505

Melanoma

A Phase III, Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined with Ipilimumab Versus Ipilimumab Monotherapy in Subjects with Previously Untreated Unresectable or Metastatic Melanoma

NCT01866319

Melanoma

A Multicenter, Randomized, Controlled, Two-Arm, Phase III Study to Evaluate the Safety and Efficacy of MK-3475 Compared to Ipilimumab in Patients with Advanced Melanoma

NCT01084252

Multiple Myeloma

A Phase I Dose Escalation Safety and Pharmacokinetic Study of Multiple Intravenous Administrations of a Humanized Monoclonal Antibody (SAR650984) Against CD38 in Patients with Selected CD38+ Hematological Malignancies

NCT01881789

Multiple Myeloma

Phase Ib/II, Multicenter, Open-Label Study of Oprozomib, Lenalidomide, and Dexamethasone in Patients with Newly Diagnosed Multiple Myeloma

NCT01583283

Multiple Myeloma

A Phase I, Open Label, Multicenter Study of ACY-1215 in Combination with Lenalidomide and Dexamethasone for the Treatment of Relapsed or Relapsed/Refractory Multiple Myeloma

NCT01894477

Myelodysplatic Syndrome

A Randomized Phase II Multicenter Study of Treosulfan, Fludarabine, and Low-Dose TBI as Conditioning for Allogeneic Hematopoietic Cell Transplantation in Patients with Myelodysplastic Syndrome (MDS)

NCT01465659

Pancreas Cancer

A Phase I/II Study of the Combination of Temozolomide and Pazopanib in Advanced Pancreatic Neuroendocrine Tumors (PNET)

NCT01772953

Pediatric Transplants

A Phase II Study of Treosulfan/Fludarabine/Low-Dose Total Body Irradiation as a Preparative Regimen for Children with AML/MDS Undergoing Allogeneic Hematopoietic Cell Transplantation

NCT01858740

Pediatric Transplants

A Phase II Study of Selective Depletion of CD45RA+ T Cells from Allogeneic Peripheral Blood Stem Cell Grafts for the Prevention of GVHD in Children

NCT01881867

Prostate Cancer

A Phase II Study of Recombinant Glycosylated Human Interleukin-7 (CYT107) after Completion of Standard FDA Approved Therapy with Sipuleucel-T (Provenge®) for Patients with Asymptomatic or Minimally Symptomatic Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT01236885

Transplant

Use of Computer-Guided Glucose Management Systems for Patients Undergoing Blood and Marrow Transplants (BMT)



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.