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Clinical Trials Monthly - November 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 large b-cell lymphoma, t-cell lymphoma, myelodysplastic syndrome, and bladder cancer (urothelial carcinoma).

Testing Immunotherapy Against Bladder Cancer

Bladder cancer is the fourth most common cancer in men and 12th most common for women. “The average five-year survival rate for bladder cancer by stage falls from 70 percent for localized disease to 33 percent for regional disease, yet this cancer is greatly under-studied and significantly underfunded,” said Jonathan L. Wright, MD, MS, FACS, assistant professor in the department of urology at the University of Washington School of Medicine.

Over the past year, a new trial hopes to turn these statistics around. Wright is principal investigator in a Dendreon-sponsored trial: Randomized, Phase II, Open-Label Study Evaluating DN24-02 as Adjuvant Therapy in Subjects with High Risk HER2+ Urothelial Carcinoma (NCT01353222). (See page 2)

“A significant portion of bladder cancers will express HER2, like breast cancers,” Wright said. “The technique in this trial uses the immune system of high-risk patients to target HER2.”

After it has been determined that HER2 is present, the patient’s blood is drawn and exposed to the antigen. The patient’s blood is then reinfused at three separate times over two-week intervals. This trial is open to patients with urothelial carcinoma with ≥pT2 disease after surgical removal, with or without positive lymph nodes. The primary endpoint is overall survival. Side effects from the treatment may include fever and chills.

“Bladder cancer is under-studied and we are very excited to offer this trial in this arena,” Wright said. “We’re working toward more research and finding a cure.”

If you have questions about the trial, contact Hamideh Razazi, research coordinator, at hrazazi@seattlecca.org or (206) 288-1230, or Dr. Wright at jlwright@fhcrc.org.

Lymphoma

Zevalin for Newly Diagnosed Diffuse Large B-Cell Lymphoma

A Phase III, Open-Label, Multicenter, Randomized Study of Sequential Zevalin (Ibritumomab Tiuxetan) versus Observation in Patients at Least 60 Years of Age with Newly Diagnosed Diffuse Large B-Cell Lymphoma in PET-Negative Complete Remission After R-CHOP or R-CHOP-Like Therapy (NCT01510184)

Zevalin is a radioimmunotherapy. This study involves treating patients with a monoclonal antibody attached to a radioactive charge, yttrium 90, and will compare the effects of the study treatment with observation (no further therapy) in patients who achieved complete response after chemotherapy for diffuse large B-cell lymphoma. Rituximab, an immunotherapy already approved by the U.S. Food and Drug Administration for lymphoma treatment, will also be given as part of the study drug treatment plan. Investigator: Ajay K. Gopal, MD

SGN-35 + CHP versus CHOP for T-Cell 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 (NCT01777152)

Brentuximab vedotin is an antibody drug conjugate (ADC). ADCs usually have two parts; a part that targets cancer cells (the antibody) and a cell-killing part (the chemotherapy). The antibody part of brentuximab vedotin sticks to a target called CD30, an important molecule on some cancer cells, including some types of mature T-cell lymphomas (MTCL) and some normal cells of the immune system. The cell-killing part of brentuximab vedotin is a chemotherapy called monomethyl auristatin E (MMAE). It can kill cells to which the antibody part of brentuximab vedotin attaches. Patients who take part in this study will have CD30 on their tumor cells. This trial is open to MTCL patients who have never been treated. This study compares standard treatment, CHOP, which is cyclophosphamide, hydroxydaunorubicin, vincristine (Oncovin), and prednisone, to a combination of treatment that replaces vincristine with brentuximab vedotin. The combination treatment is called A+CHP, which is brentuximab vedotin (Adecetris) plus cyclophosphamide, hydroxydaunorubicin, and prednisone. Investigator: Andrei R. Shustov, MD

Myelodysplastic Syndrome

Azacitidine Plus Best Supportive Care for Low-Risk Myelodysplastic Syndrome

A Phase III, Multicenter, Randomized, Double-Blind Study to Compare the Effi cacy 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 

This study will examine if people with Myelodysplastic Syndromes (MDS) need fewer blood transfusions if they take an experimental drug called azacitidine (also called oral azacitidine). Sponsored by the Celgene Corporation, this study will compare oral azacitidine to placebo to determine its effect on patients and their disease as well as patient quality of life. Researchers will also look at any genetic and chemical abnormalities present in patients’ diseased cells and whether these abnormalities play a role in how the disease responds to oral azacitidine. Investigator: Bart Lee Scott, MD

Urologic Cancer

DN24-02 for High-Risk HER2+ Urothelial Carcinoma (Dendreon Neuvenge)

A Randomized, Phase II, Open-Label Study Evaluating DN24-02 as Adjuvant Therapy in Subjects with High Risk HER2+ Urothelial Carcinoma (NCT01353222)

DN24-02 is an autologous cellular immunotherapy product designed to stimulate an immune response against HER2/neu. It consists of autologous peripheral blood mononuclear cells, including antigen presenting cells, which are activated ex vivo with a recombinant fusion protein. This study will evaluate the safety of DN24-02, an investigational drug, to determine if it will help patients live longer, and if the immune system will respond to treatment with it. Investigator: Jonathan L. Wright, MD, MS, FACS
 

Hotlist

NCI Designation

Disease Site

Description

NCT01353222

Bladder

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

7754

Brain

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

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

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

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)

NCT01723943

Breast Cancer/Spouses

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

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

NCT01730950

Glioblastoma

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

NCT00916409

Glioblastoma

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

NCT01266031

Glioblastoma

Phase I/II Adaptive Randomized Trial of Bevacizumab Versus Bevacizumab Plus Vorinostat in Adults With Recurrent 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

NCT01556490

Liver Cancer

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

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

NCT01718353

Prostate

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

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

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, 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

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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