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Clinical Trials Monthly - December 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 colorectal cancer, multiple myeloma, and myelodysplastic syndrome.

Phase II Antibody Trial Opens for Multiple Myeloma

There has yet to be an antibody treatment for patients with multiple myeloma (MM). Seattle Cancer Care Alliance’s William Bensinger, MD, is pleased to announce the December opening of a Phase II antibody trial that had promising Phase I results for MM patients.

“This is exciting,” Bensinger said. “This is a new way to treat patients, especially relapsed or advanced patients who aren’t responding to other treatments.” The Phase II portion of the dose escalation study of multiple intravenous administrations of a humanized monoclonal antibody (SAR650984) against CD38 in patients with selected CD38+ hematological malignancies (NCT01084252) will move to six doses.

This study is open in at least six other centers across the country. Patients in the Phase II portion of this trial will receive SAR650984 at 10 mg/kg by intravenous infusion every other week. They will continue to receive the drug as long as it remains beneficial. “It’s also worth noting that at the American Society of Hematology (ASH) meeting, this antibody had significant single-agent activity in heavily pre-treated myeloma patients,” Bensinger said. Read more about this trial. 

Colorectal Cancer

Folfoxiri/Avastin versus Folfox/Avastin for Metastatic Colorectal Cancer

Steam (Sequential Triplet and Avastin Maintenance): Folfoxiri/Bevacizumab Regimens (Concurrent and Sequential) versus Folfox/Bevacizumab in First-Line Metastatic Colorectal Cancer (NCT01765582) 

The purpose of this study is to learn the effects of bevacizumab (Avastin) when combined with different chemotherapy to treat metastatic colorectal cancer. Patients will initially receive bevacizumab combined with one of three chemotherapies: concurrent FOLFOXIRI (all drugs will be given during the same treatment cycle) or sequential FOLFOXIRI (some drugs will alternate on a monthly basis), or the commonly used FOLFOX chemotherapy treatment. Throughout the course of this study, chemotherapies will be modified, with some of the cancer drugs discontinued, reintroduced, or replaced. The study doctor or staff will notify patients of all changes. Bevacizumab is a humanized monoclonal antibody designed to bind to vascular endothelial growth factor (VEGF), which is important for angiogenesis. Bevacizumab interferes with the tumor blood supply by directly attaching to VEGF and upsetting growth and maintenance of these blood vessels. It does not bind to proteins on normal cells or cancer cells. Bevacizumab has been effective in a variety of tumor types. Although the U.S. Food and Drug Administration (FDA) has approved it, bevacizumab is not commonly used with FOLFOXIRI in the United States. Genentech is comparing the efficacy and safety of bevacizumab with the concurrent and sequential FOLFOXIRI treatment plans (Arms A and B) to the more commonly used treatment plan of FOLFOX with bevacizumab (Arm C). Investigator: Gabriela Chiorean, MD

Myelodysplastic Syndrome

Chemotherapy for MDS Patients Prior Donor Stem Cell Transplant

Initial Cytoreductive Therapy for Myelodysplastic Syndrome Prior to Allogeneic Hematopoietic Cell Transplantation (The ICT-HCT Study) (NCT01812252)

The purpose of this study is to examine the initial treatment of patients with intermediate and high-risk myleodysplastic syndrome (MDS) who may have a bone marrow transplant as part of their treatment. This study will look at whether a less-intensive chemotherapy, with azacitidine (Vidaza) and decitabine (Dacogen), prior to transplant is better than a more intensive, induction chemotherapy. The FDA has approved both drugs for treating MDS. Investigator: Bart Lee Scott, MD

Multiple Myeloma

Carfilzomib and Pomalidomide with Dexamethasone for Relapsed or Refractory Multiple Myeloma

A Multicenter Phase I/II, Open-Label, Dose-Finding Pilot Study of the Combination of Carfilzomib and Pomalidomide with Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma (NCT01464034) 

This is a two-phase study. Phase I will evaluate the safety and determine the maximum tolerated dose of the combination of carfilzomib and pomalidomide with dexamethasone (CPD) in patients with relapsed or refractory MM. Phase II of the study will use the dose that was determined to be the most safe and effective. The study will explore the efficacy of CPD, including overall response, time to progression, progression-free survival, and time to next therapy. Carfilzomib (Kyprolis) is a proteasome inhibitor that the FDA has approved only for certain U.S. patients with relapsed and refractory MM that have tried and failed other therapies. In this study, however, it is considered investigational. Pomalidomide is an oral investigational immunomodulatory drug, similar to thalidomide and lenalidomide, both of which have been approved for MM treatment. Investigator: William I. Bensinger, MD

Lenalidomide/Dexamethasone for Newly Diagnosed Myeloma

A Phase III, Randomized, Open Label Trial of Lenalidomide/Dexamethasone with or without Elotuzumab in Subjects with Previously Untreated Multiple Myeloma (NCT01335399) 

The purpose of the study is to determine whether the addition of an investigational drug, elotuzumab, with lenalidomide and low-dose dexamethasone is more effective in the initial treatment of MM than the standard treatment of lenalidomide and dexamethasone alone. The safety of the two treatments will be compared as will how the body processes elotuzumab. In laboratory studies, elotuzumab targets and kills MM cells, and earlier studies have shown encouraging results. The combination of lenalidomide and dexamethasone has been approved for MM patients who’ve had at least one treatment for MM. Although it is commonly used for newly diagnosed MM patients, the FDA has not yet approved it for those newly diagnosed with MM. Investigator: William I. Bensinger, 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 and Cisplatin/Gemcitabine for Treatment of Patients with Bladder Cancer

NCT01236885

Bone Marrow Transplant

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

7754

Brain

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

NCT01928186-a

Breast Cancer

Imaging Early Response of ER+, HER2- Breast Cancer to Aromatase Inhibitor (AI) +/- Ovarian Suppression (OS) Therapy with [18F]Fluorothymidine (FLT) PET

NCT01928186-b

Breast Cancer

Imaging Early Response of ER+, HER2- Breast Cancer to Aromatase Inhibitor (AI) +/- Ovarian Suppression (OS) Therapy with [18F]Fluorothymidine (FLT) PET

NCT01931709

Breast Cancer

Quantitative Dynamic PET and MRI and Breast Cancer Therapy

NCT01535066

Breast Cancer

Randomized Blinded Sham- and Waitlist-Controlled Trial of Acupuncture for Joint Symptoms Related to Aromatase Inhibitors in Women with Early Stage Breast Cancer

NCT01816035

Breast Cancer

Thrombokinetic Studies of Trastuzumab Emtansine

NCT01908101

Breast Cancer

Phase II Trial of Metronomic Eribulin (Halaven) in Pretreated Metastatic Breast Cancer (MBC)

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

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

NCT01716715

Gynecologic Cancer

A Randomized Phase II 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

NCT01666444

Gynecologic Cancer

A Randomized, Double-Blind, Placebo-Controlled Phase II Study of VTX-2337 in Combination with Pegylated Liposomal Doxorubicin (PLD) in Patients with Recurrent or Persistent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

NCT01254630

Infection Control

A Phase III Randomized, Placebo-Controlled, Clinical Trial to Study the Safety and Efficacy of V212 in Adult Patients with Solid Tumor or Hematologic Malignancy

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

NCT01777152

Lymphoma

A Randomized, Double-Blind, Placebo-Controlled, Phase III Study of Brentuximab Vedotin and CHP (A+CHP) versus CHOP in the Frontline Treatment of Patients with CD30-Positive Mature T-Cell Lymphomas

NCT01921387

Lymphoma

A Phase I/II Study Evaluating Escalating Doses of 90Y-BC8-DOTA (anti-CD45) Antibody followed by BEAM Chemotherapy and Autologous Stem Cell Transplantation for High-Risk Lymphoid Malignancies

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

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

NCT01465659

Pancreatic Cancer

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

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

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

NCT01799278

Prostate Cancer

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

NCT01884285

Prostate Cancer

A Phase I, Open-Label, Multi-Center 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

NCT01957709

Sarcoma

A Pilot Study to Test Whether Systemic Interferon Gamma Increases Tumor Class I MHC Expression in Patients with Synovial Sarcoma and Myxoid/ Round-Cell Liposarcoma



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Pediatric Bone Marrow Transplant News

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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.

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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.