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Research Trials

Oncology Trials

See also: breast cancer research trials
If you are a physician or patient and want to learn about the below oncology clinical trials offered at Sibley, please contact Effat Bennett, M.S.N., Ed.D, B.S.N., O.C.N., 202-660-6324, ebenne25@jhmi.edu.

TopicTitleStudy IDSibley PI
ProstateStereotactic Body Radiation Therapy and Short-Term Androgen Ablation for Intermediate-Risk, Localized Adenocarcinoma of the ProstateJ11157Curtiland Deville, M.D.
ProstateHypofractionated Adaptive Image-Guided Radiation Therapy for Localized Adenocarcinoma of the ProstateJ0859Curtiland Deville, M.D.
ProstatePhase II Randomized Placebo-Controlled Double-Blind Study of Salvage Radiation Therapy (SRT) Plus Placebo Versus SRT Plus Enzalutamide in Men with High-Risk PSA-Recurrent Prostate Cancer after Radical ProstatectomyJ1454Curtiland Deville, M.D.
ProstatePhase II Randomized Observation versus Stereotactic Ablative RadiatIon for OLigometastatic Prostate CancEr (ORIOLE) TrialJ15180Curtiland Deville, M.D.
ProstateA Phase 3, Randomized, Efficacy and Safety Study of Enzalutamide Plus Leuprolide, Enzalutamide Monotherapy, and Placebo Plus Leuprolide in Men With High-Risk Nonmetastatic Prostate Cancer Progressing After Definitive Therapy (Protocol Number: MDV3100-13)J15188Channing Paller, M.D.
ProstateA Phase 3, Randomized, Efficacy and Safety Study of Enzalutamide Plus Leuprolide, Enzalutamide Monotherapy, and Placebo Plus Leuprolide in Men With High-Risk Nonmetastatic Prostate Cancer Progressing After Definitive Therapy (Protocol Number: MDV3100-13)J15188Channing Paller, M.D.
ProstateOvercoming drug resistance in metastatic castration-resistant prostate cancer with novel combination of TGF-β receptor inhibitor LY2157299 and enzalutamide: a randomized multi-site phase II studyJ1416Channing Paller, M.D.
ProstateA Randomized Phase II Study Comparing Bipolar Androgen Therapy vs. Enzalutamide in Asymptomatic Men with Castration Resistant Metastatic Prostate Cancer: The TRANSFORMER TrialJ1557Channing Paller, M.D.
ProstateA Randomized Phase 2 Trial of Ascorbic Acid in Combination with Docetaxel in Men with Metastatic Prostate CancerJ15106Channing Paller, M.D.
ProstateA Randomized Phase 2 Study of Sipuleucel-T with or without Radium-223 in Men with Asymptomatic or Minimally Symptomatic Bone-Metastatic Castrate-Resistant Prostate CancerJ1522Channing Paller, M.D.
ProstateA biospecimen bank and study to understand genitourinary cancer and other benign urologic conditions.J1380A. Smith, M.D.
ProstateUnderstanding mechanisms of response and resistance to androgen-directed therapies in men with advanced prostate cancer through interrogation of tumor biopsies (with a focus on androgen receptor variants): A pilot/feasibility studyJ1262Channing Paller, M.D.
ProstateImmune Evaluation Study of Sipuleucel-T in African American and non-African American Men with Castrate Resistant Prostate Cancer (Karmanos Cancer Institute protocol # 2013-108);J1409Channing Paller, M.D.
ProstateDevelopment of Circulating Molecular Predictors of Chemotherapy and Novel Hormonal Therapy Benefit in Men with Metastatic Castration Resistant Prostate Cancer (mCRPC)J14136Channing Paller, M.D.
GenitourinaryA Randomized Phase II Study of Co-Expression Extrapolation (COXEN) with Neoadjuvant Chemotherapy for Localized, Muscle-Invasive Bladder CancerS1314A. Smith, M.D.
GenitourinaryA Prospective Phase II Trial of Neoadjuvant Systemic Chemotherapy Followed by Extirpative Surgery for Patients with High Grade Upper Tract Urothelial CarcinomaEA8141A. Smith, M.D.
GenitourinaryA Randomized, Phase II Efficacy Assessment of Multiple MET Kinase Inhibitors (Cabozantinib, Crizotinib, Savolitinib, and Sunitinib) in Metastatic Papillary Renal Carcinoma (PAPMET)S1500Michael Carducci, M.D.
Lung - metastaticA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Long-Term Safety and Efficacy of Darbepoetin Alfa Administered Once-Every-3-Weeks in Anemic Subjects with Advanced Stage Non-small Cell Lung Cancer Receiving Multi-Cycle ChemotherapySIB1301Fred Smith, M.D.
Lung -
non-metastatic
Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)A151216Fred Smith, M.D.
Lung -
non-metastatic
Randomized Double Blind Placebo Controlled Study of Erlotinib or Placebo in Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-small Cell Lung Cancer (NSCLC)A081105Fred Smith, M.D.
Lung -
non-metastatic
A Phase III Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib Versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion ProteinNCTNE4512Fred Smith, M.D.
GynecologicAcquisition of Gynecologic Tissues, Cervical Cytology, Ascites, and Serum SpecimensGY004Bruce Kressel, M.D. 
GynecologicA Phase III study comparing single-agent olaparib or the combination of cediranib and olaparib to standard platinum-based chemotherapy in women with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancerJ9883Jeffery Lin, M.D.
GynecologicA Randomized Phase II/III study of the combination of Cediranib and Olaparib compared to Cediranib or Olaparib alone, or Standard of care chemotherapy in women with recurrent platinum-resistant or -refractory ovarian, fallopian tube, or primary peritoneal cancer (COCOS)GY005Bruce Kressel, M.D. 
OtherMolecular Analysis for Therapy (MATCH)EAY131Michael Carducci, M.D.
OtherImmunobiology Blood and Tissue Collection ProtocolJ13139Evan Lipson, M.D.
HemeE1412 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 LymphomaNCTNE1412Bruce Kressel, M.D. 
MelanomaCirculating tumor DNA (ctDNA) in advanced melanoma: analysis of concordance with tissue and the role of ctDNA in managing anti-cancer therapyJ1552Evan Lipson, M.D.
BrainA phase II trial of low dose fractionated radiation therapy as a chemo-potentiator of salvage temozolomide for recurrent anaplastic astrocytoma and glioblastoma multiformeJ11120Victoria Croog, M.D.
BrainA Randomized Phase II Study of Subventricular Zone (SVZ) Irradiation Plus Temozolomide in Newly Diagnosed Glioblastoma MultiformeJ1426Victoria Croog, M.D.
PediatricsA Phase II Study of Hypofractionated Stereotactic Radiotherapy in the Treatment of Metastatic Pediatric Sarcomas of Bony SitesJ1367Matthew Ladra, M.D.

Miscellaneous Trials

If you are a physician or patient and want to learn about the below clinical trials offered at Sibley, please contact Courtney M. Southard, M.P.H., 202-660-6767, csoutha1@jhmi.edu.

TopicTitleSibley PI
Gastroenterology & HepatologyMulticenter, Randomized Phase 2B Study to Evaluate the Efficacy, Safety and Tolerability of OCR-002 (ornithine phenylacetate) in Hospitalized Patients with Cirrhosis and Associated Hyperammonemia with an Episode of Hepatic Encephalopathy STOP-HE Study Kirti Shetty, M.D.
Gastroenterology & Hepatology
 
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients with Nonalcoholic Steatohepatitis (NASH) and fibrosis
Kirti Shetty, M.D.
Gastroenterology & HepatologyA Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial of Emricasan (IDN-6556), an Oral Caspase Inhibitor, in Subjects with Non-alcoholic Steatohepatitis (NASH) FibrosisKirti Shetty, M.D.