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Department of Medicine Annual Report FY 2014

Clinical Trials

Division of Hematology & Oncology:
CLINICAL TRIALS

All trials open to accrual by primary investigator 07/01/2013 – 06/30/2014
**Newly opened to accrual FY2014

Amer Beitinjaneh, PI

  • DEFLECT-1: A Phase 3b Multi-Center, Double-Blind, Randomized, Placebo Controlled Study to Demonstrate the Safety and Efficacy of Fidaxomicin for Prophylaxis against CLostridium difficilE-Associated Diarrhea in Adults Undergoing Hematopoietic Stem Cell Transplantation (Optimer)

Thao P. Dang, PI

  • The Use of Circulating Tumor Cells in Non-Small Cell Lung Cancer: Novel Isolation Methods and Clinical Applications (UVA)
  • Randomized, Phase III, Double-Blind Placebo-Controlled Trial of Sunitinib (NSC #736511, IND #74019) as Maintenance Therapy in Non-Progressing Patients following an Initial Four Cycles of Platinum-Based Combination Chemotherapy in Advanced, Stage IIIB/IV Non-Small Cell Lung Cancer (CALGB)
  • A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB-IIIA Non-Small Cell Lung Cancer (ECOG)
  • **Phase I and Randomized Phase II Double Blind Clinical Trial of Cisplatin and Etoposide in Combination with Veliparib (ABT-888) or Placebo as Frontline Therapy for Extensive Stage Small Cell Lung Cancer (ECOG)
  • **A Phase II, Multicenter, Single-Arm Study of MPDL3280A in patients with PD-L1-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Roche)

Patrick Dillon, PI

  • A Phase 3 Open-Label, Randomized, Multicenter Study of NKTR-102 Versus Treatment of Physician’s Choice in Patients with Locally Recurrent or Metastatic Breast Cancer Previously Treated with Anthracycline, a Taxan and Capecitabine (Nektar)
  • **Multicenter, Randomized, Doubleblind, Placebo-Controlled, Phase 3 Trial of Fulvestrant (Falsodex) with or without PD-0332991(Palbociclib) + Goserelin in Women with Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer Whose Disease Progressed After Prior Endocrine Therapy (Pfizer)
  • **A Randomized, Multicenter, Open-Label, Phase III Trial Comparing Trastuzumab Plus Pertuzumab Plus A Taxane Following Anthracylines versus Trastuzumab Emtansine Plus Pertuzumab Following Anthracyclines As Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer (Roche)
  • Breast 41: A pilot study of the immunogenicity of a 9-peptide breast cancer vaccine plus poly-ICLC in stage IB-IV breast cancer (UVA)
  • **A three-arm, randomized, open label, phase II study of everolimus in combination with exemestane versus everolimus alone versus capecitabine in the treatment of postmenopausal women with estrogen receptor positive, locally advanced, recurrent, or metastatic breast cancer after recurrence or progression on prior letrozole or anastrozole (Novartis)
  • A Phase II Study of Dovitinib (TKI258) in Patients with Recurrent or Metastatic Adenoid Cystic Carcinoma (UVA)
  • A Phase II Study Evaluating The Efficacy and Tolerability of Everolimus (RAD001) in Combination with Trastuzumab and Vinorelbine in the Treatment of Progressive HER-2 Positive Breast Cancer Brain Metastases (UNC Chapel Hill)
  • **A Phase 2 Study of Docetaxel in Combination with 1-methyl-D-tryptophan indoximod) in Metastatic Breast Cancer (NewLink Genetics)
  • The effect of the Nia Technique on the quality of life among participants with treated breast cancer (UVA)
  • 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 (NSABP)
  • A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score (RS) of 25 or Less (ECOG)

Michael Douvas, PI

  • **A phase II randomized, multicenter study of treatment-free remission in chronic myeloid leukemia in chronic phase (CML-CP) patients who achieve and sustain MR4.5 after switching to nilotinib (Novartis)
  • Detecting and Monitoring Hematologic Malignancies Through a New Molecular Method Named Anchored ChromPET (Chromosomal Paired End Tags) (UVA)
  • **A randomized, double-blind, placebo-controlled, phase 3 study of brentuximab vedotin and CHP (A+CHP) versus CHOP in the frontline treatment of patients with CD30-positive mature T-cell lymphomas (Seattle Genetics)
  • Development of Small Molecule Inhibitors of Core Binding Factor Mutations in Acute Leukemias (UVA)

Tamila Kindwall-Keller, PI

  • Defibrotide for Patients with Hepatic Veno-Occlusive Disease(VOD): A Treatment IND Study(Under CFR 312.34) (Gentium)
  • A multicenter safety study of unlicensed, investigational cryopreserved cord blood units (CBUs) manufactured by the National Cord Blood Program (NCBP) and provided for unrelated hematopoietic stem cell transplantation of pediatric and adult patients (National Cord Blood Program)
  • **A Prospective Observational Study of the Association Between CD34+ Cell-Dose Infused in Autologous Stem Cell Transplantation and Engraftment in Multiple Myeloma Patients (UVA)

James Stone, PI

  • A Phase III Clinical Trial Evaluating TheraSphere in Patients with Metastatic Colorectal Carcinoma of the Liver who have failed first line chemotherapy(Nordion) [Weiss was PI thru May 2014]

Geoffrey R. Weiss, PI

  • A Phase 1 Study of the Safety, Tolerability, Pharmacokinetics and Immunoregulatory Activity of BMS-663513 (Anti-CD137) in Subjects with Advanced and/or Metastatic Solid Tumors(Bristol-Myers-Squibb)
  • A Phase III Trial of 6 Versus 12 Treatments of Adjuvant Folfox Plus Celecoxib or Placebo for Patients With Resected Stage III Colon Cancer (CALGB 80702)
  • A Phase 1, Open-label, Dose-escalation, Safety and Pharmacokinetic Study of CDX-1127 in Patients with Selected Refractory or Relapsed Hematologic malignancies or Solid Tumors (Celldex Therapeutics)
  • A Multi-Center, Randomized, Placebo-Controlled Phase II Study of Regorafenib in Combination With FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) Versus Placebo With FOLFIRI as Second-Line Therapy in Patients with K-RAS or BRAF Mutant Metastatic Colorectal Cancer (UNC)
  • **A Multicenter, Randomized, Controlled, Three-Arm, Phase III Study to Evaluate the Safety and Efficacy of MK-3475 Compared to Ipilimumab in Patients with Advanced Melanoma (Merck)
  • A Phase III Clinical Trial Evaluating TheraSphere in Patients with Metastatic Colorectal Carcinoma of the Liver who have failed first line chemotherapy(Nordion) [Weiss was PI thru May 2014, current PI is James Stone]

Michael Williams, PI

  • Prospective, Longitudinal, Multinational Registry of Patients With Newly Diagnosed Peripheral T-Cell Lymphoma (Allos Therapeutics)
  • Investigator-initiated study to evaluate the long-term toxicity and efficacy of bendamustine in patients with non-Hodgkin lymphoma treated on five phase 2 trials (Weill Cornell)
  • **A Phase 1b, Open-label, Multicenter Study of Urelumab (BMS-663513) in Combination with Rituximab in Subjects with Relapsed/Refractory B-Cell Malignancies (Bristol-Myers-Squibb)
  • Intergroup Randomized Phase II Four Arm Study In Patients >= 60 With Previously Untreated Mantle Cell Lymphoma (ECOG)
  • **Randomized Phase II Open Label Study of Lenalidomide R-CHOP (R2CHOP) vs RCHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone) in Patients with Newly Diagnosed Diffuse Large B Cell Lymphoma (ECOG)
  • **An Open-Label Treatment Use Protocol for Ibrutinib (PCI-32765) in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (Janssen)

 

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