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Clinical Trials Monthly - March 2014

The knowledge we gain from clinical trials helps us develop more effective, less toxic cancer treatments. Each month we publish this newsletter with our Hotlist of new clinical trials that may be of interest to you and your patients.

Positive Outcomes with Novel Treatments

SCCA investigator Ajay K. Gopal, MD, was the first author on a January 2014 New England Journal of Medicine paper about idelalisib, an orally active selective PI3Kδ inhibitor that, in a Phase I study, showed antitumor activity in patients with previously treated indolent non-Hodgkin’s lymphoma.

This paper detailed the single-group, open-label, Phase II study (PI3Kδ Inhibition by Idelalisib in Patients with Relapsed Indolent Lymphoma) that SCCA physicians were involved in designing and had the highest accrual of patients for. It featured 125 patients with indolent non-Hodgkin’s lymphoma who had not had a response to rituximab and an alkylating agent or had a relapse within six months after receipt of those therapies. These patients received 150 mg of idelalisib twice daily until the disease progressed or the patient withdrew from the study.

“New therapies, like idelalisib, have the potential to dramatically alter the treatment paradigm for indolent B-cell lymphomas and emphasize the importance of consideration of clinical trials for ones’ patients,” said Gopal.

SCCA was the highest-accruing center in the country for this study, in which idelalisib showed antitumor activity in patients who had received extensive prior treatment.

“This trial demonstrates the kinds of novel, breakthrough therapies we can offer at our institution,” said Jennifer Roden, SCCA research manager in the University of Washington hematologic malignancies group. The full article is available in the January 22, 2014 issue of the New England Journal of Medicine, at NEJM.org.

Leukemia

Inotuzumab Ozogamicin for Relapsed Or Refractory Acute Lymphoblastic Leukemia

An Open-Label, Randomized Phase III Study of Inotuzumab Ozogamicin Compared to a Defined Investigator’s Choice in Adult Patients with Relapsed or Refractory CD22-Positive Acute Lymphoblastic Leukemia (ALL) (NCT01564784)

The purpose of this research study is to learn if the investigational drug inotuzumab ozogamicin is an effective treatment compared to regimens used in patients with relapsed or refractory acute lymphoblastic leukemia (ALL). Inotuzumab ozogamicin has not been approved by the U.S. Food and Drug Administration (FDA). Although commonly used, none of the chemotherapy regimens used in this study are FDA-approved for ALL treatment. This study will also look at how the body distributes the drug and the side effects associated with it. The goal is to enroll 194 to 292 patients. The study is being conducted globally at approximately 190 sites. Investigator: Ryan D. Cassaday, MD

 

Lymphoma

PCI-32765 (Ibrutinib) for Refractory Follicular Lymphoma

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

The purpose of this study is to assess the effects of and response to ibrutinib to treat follicular lymphoma. This study will enroll approximately 110 patients. Currently, more than 736 patients have taken ibrutinib in 19 other studies. Ibrutinib is an experimental drug, and a Bruton’s Tyrosine Kinase (BTK) inhibitor that blocks an enzyme (protein) that affects how non-Hodgkin’s lymphoma-affected white blood cells grow and survive. Blocking this enzyme is an important mechanism in killing these cancer cells. Ibrutinib is not approved by any regulatory authority in any country, including the FDA. Investigator: Ajay K. Gopal, MD

Lung Cancer

Alisertib in Combination with Paclitaxel for Small Cell Lung Cancer

Phase II Study of Alisertib (MLN8237) in Combination with Paclitaxel versus Placebo in Combination with Paclitaxel as Second-Line Therapy for Small Cell Lung Cancer (SCLC) (NCT02038647)

This is a double-blind, randomized study of an investigational drug called alisertib, also known as MLN8237. Alisertib is given orally as tablets, and was developed as a possible treatment for patients with small cell lung cancer as a second-line therapy in combination with paclitaxel. The purpose of this study is to measure the safety and length of disease response during and after treatment with alisertib in combination with paclitaxel or a placebo in combination with paclitaxel. Patients will provide blood and a tumor tissue sample for biomarker research, which is part of this evaluation. Researchers will also perform genetic testing to identify, confirm, and validate biomarkers to alisertib (MLN8237). Investigator: Christina S. Baik, MD, MPH

Rectal Cancer

Chemotherapy or Chemotherapy + Radiation for Rectal Cancer Patients Undergoing Surgery (The Prospect Trial)

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). Depending on response to the FOLFOX, treatment may also include a selective use of 5FUCMT. The drugs in the FOLFOX regimen are all approved by the FDA and have been used routinely since 2002 to treat patients with advanced colorectal cancer. More information about the trial is available on the SCCA Blog. Investigators: Alessandro Fichera, MD, and Veena Shankaran, MD

Hotlist

NCI Designation

Disease Site

Description

NCT01564784

Acute Lymphoblastic Leukemia

An Open-Label, Randomized Phase III Study Of Inotuzumab Ozogamicin Compared to a Defined Investigator's Choice in Adult Patients with Relapsed or Refractory CD22-Positive Acute Lymphoblastic Leukemia (ALL)

NCT01744223

Bone Marrow Transplant

A PhaseI/II Dose Escalation Study Evaluating Safety and Feasibility of BPX-501 T Cells after Partially Mismatched, Related, T Cell-Depleted HSCT

NCT01969643

Breast Cancer

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

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

NCT01295710

GVHD

Phase III Study of US-ATG-F to Prevent Moderate to Severe Chronic GVHD in Adult Acute Myeloid Leukemia, Acute Lymphoid Leukemia, and Myelodysplastic Syndrome Patients After Allogeneic Stem Cell Transplantation from Unrelated Donors

NCT01610414

GVHD

Phase III Randomized Observer Blind Study to Evaluate Efficacy, Safety ,and Immunogenicity of GSK Biologicals Herpes Zoster Vaccine GSK1437173A

NCT01982123

Lung Cancer

Pulmonary Functional Imaging for Radiation Treatment Planning for Lung Cancer

NCT01752114

Lung Nodules

Early Diagnosis of Pulmonary Nodules Using a Plasma Proteomic Classifier

NCT01728805

Lymphoma

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

NCT01855750

Lymphoma

A Randomized, Double-Blind, Placebo-Controlled Phase III Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, PCI-32765 (Ibrutinib), in Combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects with Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma

NCT01712490

Lymphoma

A Randomized, Open-Label, Phase III Trial of A+AVD Versus ABVD as Frontline Therapy in Patients with Advanced Classical Hodgkin's Lymphoma

NCT01991184

Lymphoma

An Open-Label, Phase I, Dose-Escalation Study Evaluating the Safety and Tolerability of GDC-0853 in Patients with Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia

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

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

Myelodysplastic 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)

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

NCT02061761

Phase I/Leukemia/Lymphoma

A Phase I Dose Escalation and Cohort Expansion Study of the Safety, Tolerability, and Efficacy of Anti-LAG-3 (BMS-986016) in Relapsed or Refractory Chronic Lymphocytic Leukemia and Lymphomas

NCT01988896

Phase I/Metastatic Solid Tumors

A Phase Ib Study of the Safety and Pharmacology of MPDL3280A Administered with Cobimetinib in Patients with Locally Advanced or Metastatic Solid Tumors

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)

NCT01946204

Prostate Cancer

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men with Non-Metastatic (M0) Castration-Resistant Prostate Cancer



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.