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PROVIDER INFORMATION SHEET
Cancer Clinical Studies at
Virginia Mason Medical Center
This list represents the clinical studies in cancer treatment and cancer control approved by the Benaroya Research
Institute Institutional Review Board for use within Virginia Mason Medical Center. For more information please call us at
206.342.6954, email us, or visit ClinicalTrials.gov and enter the National Cancer Institute ID; there you will find study
schema, objectives, eligibility criteria and more.
Tumor Tissue Repository
VM BRITE: Virginia Mason Medical Center and Benaroya Research Institute Tumor Tissue Repository| PI: Prakash
Vishnu, MD
Bladder
A phase II single arm clinical trial of nivolumab (BMS-936558) in subjects with metastatic or unresectable urothelial
cancer who have progressed or recurred following treatment with a platinum agent | Study IDs: IRB15013,
NCT02387996| PI: Kamal Chatta, MD, CRC: Emma Bishop
Brain
Phase III Intergroup Study of Temozolomide Alone versus Radiotherapy with Concomitant and Adjuvant
Temozolomide versus Radiotherapy and Adjuvant PCV Chemotherapy in Patients with 1p/19q Codeleted Anaplastic
Glioma | Study IDs: N0577, NCT00887146| PI: Craig Nichols, CRC: Kathy Rabena
Randomized Phase II Trial of Concurrent Bevacizumab and Re-Irradiation vs. Bevacizumab Alone as Treatment for
Recurrent Glioblastoma| Study IDs: RTOG 1205, IRB13055, NCT01730950|PI: Huong Pham, MD, CRC: Kathy Rabena
A Phase III Clinical Trial Evaluating DCVax®-L, Autologous Dendritic Cells Pulsed With Tumor Lysate Antigen For The
Treatment Of Glioblastoma Multiforme (GBM)| Protocol ID: IRB14115, NCT00045968| PI: Lynne Taylor, MD, CRC: Leila
Ponce
Breast
Intra-Operative Radiotherapy after breast conserving therapy in the treatment of in situ and early stage breast
cancer. Study IDs: IRB11143 | PI: Janie Grumley, MD, CRC: Suzanne Vogt
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|Study IDs: IRB11055, SWOG 1007, NCT01272037 | PI: Nanette Robinson, MD, CRC: Kathy Rabena
Impact of Breast Conservation Surgery on Surgical Outcomes and Cosmesis in Patients with Multiple Ipsilateral Breast
Cancers (MIBC) |Study IDs: IRB14056, NCT01556243 | PI: Nanette Robinson, MD, CRC: Kathy Rabena
A phase III, randomized, open label, multicenter, controlled trial of niraparib versus physician’s choice in previouslytreated, HER2 negative, germline BRCA mutation-positive breast cancer patients. |Study IDs: IRB14054 | PI: Nanette
Robinson, MD, CRC: Kathy Rabena
An Observational Cohort Study of Treatment Patterns and Outcomes in Patients with HER2+ Metastatic Breast Cancer.
|Study IDs: IRB14027; NCT01615068| PI: Nanette Robinson, MD, CRC: Kathy Rabena
Hormone Therapy With or Without Everolimus in Treating Patients with Breast Cancer
Study ID: IRB15039; S1027|PI: Nanette Robinson, MD|CRC: Kathy Rabena
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Colorectal
A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas
and Second Primary Colorectal Cancers in Patients with Stage 0-III Colon Cancer, Phase III | Study IDs: SWOG S0820,
IRB12025 | PI: Craig Nichols, CRC: Zoya Hyder
A Randomized, Double-Blind Study of Ruxolitinib or Placebo in Combination with Regorafenib in Subjects with Relapsed
or Refractory Metastatic Colorectal Cancer | Study IDs: IRB14113, NCT02119676 | PI: Bruce Lin, MD, CRC: Emma Bishop
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 (PROSPECT) | Study IDs: IRB15044 | PI: Bruce Lin, MD, CRC: Emma Bishop
Gastric
A Phase III Randomized, Double-Blind, Placebo-Controlled Clinical Trial of BBI608 plus Weekly Paclitaxel vs. Placebo
plus Weekly Paclitaxel in Adult Patients with Advanced, Previously Treated Gastric and Gastro- Esophageal Junction
Adenocarcinoma | STUDY IDs #: IRB 14073, NCT02178956 | PI: Bruce Lin, MD, CRC: Zoya Hyder
Gynecological
Can Diet and Physical Activity Modulate Ovarian, Fallopian Tube and Primary Peritoneal Cancer for Progression-Free
Survival? | Study ID: IRB12119; GOG 225; NCT00719303| PI: Amy Brockmeyer, CRC: Allison Singer
A Randomized Phase III Study of Standard versus IMRT Pelvic Radiation for Post-Operative Treatment of Endometrial
and Cervical Cancer (Time-C) | Study ID: IRB13177| PI: Huong Pham, CRC: Allison Singer
Pre-Operative Assessment and Post-Operative Outcomes of Elderly Women with Gynecologic Cancers | Study ID:
IRB15038; NRG-CC002; NCT 02315469 | PI: Amy Brockmeyer, CRC: Allison
Hepatobiliary
A Randomized, Double Blind, Placebo Controlled, Multicenter Phase III Study of Regorafenib in Patients with
Hepatocellular Carcinoma (HCC) after Sorafenib (RESORCE) | Study IDs: NCT01774344, IRB13064 | PI: Bruce Lin, MD,
CRC: Kathy Rabena
DELTIC: Drug-Eluting Bead, Irinotecan Therapy of Unresectable Intrahepatic Cholangiocarcinoma (DELTIC) with
Concomitant Systemic Gemcitabine and Cisplatin | Study IDs: IRB13071 | PI: Flavio Rocha, MD, CRC: Kathy Rabena
Efficacy and Safety Study of PDT Using Photofrin in Unresectable Advanced Perihilar Cholangiocarcinoma| Study IDs:
IRB14041; NCT02082522| PI: Ian Gan, MD, CRC: Sarah Ackermann
HIV/AIDS Malignancy
A Companion Protocol to Evaluate Anogenital Human Papillomavirus (HPV) Infection and Anogenital Squamous
Intraepithelial Lesions (ASIL) in Subjects Participating in AMC Clinical Trials | Study IDs: AMC-058, IRB09053,
NCT00695422 | PI: David Aboulafia, CRC: Leila Ponce
Protective Effect of Quadrivalent Vaccine in Young HIV-Poisitve Males Who Have Sex With Males | Study IDs: AMC072, IRB10148, NCT01209325 | PI: David Aboulafia, CRC: Leila Ponce
A Phase I Study of Vorinostat in Combination With Paclitaxel and Carboplatin in Solid Tumors (With Focus on Upper
Aerodigestive Cancers) in Persons With HIV Infection | Study IDs: AMC-078, IRB11152, NCT01249443 | PI: David
Aboulafia, CRC: Leila Ponce
Improving Participation in AMC Clinical Trials | Study IDs: AMC-S006, IRB13024 | PI: David Aboulafia, MD, CRC: Leila
Ponce
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AMC-087, Phase I Trial of Cabozantinib (XL 184) for Advanced Solid Tumors in Persons with HIV Infection| Study IDs:
AMC-087 | PI: David Aboulafia, MD, CRC: Leila Ponce
AMC-088, A Randomized, Phase III Study of Intra-Anal Imiquimod 2.5% versus Topical 5-Fluorouracil 5% versus
Observation for the Treatment of High-Grade Anal Squamous Intraepithelial Lesions in HIV-Infected Men and Women
| Study IDs: AMC-088, IRB11152, NCT01249443 | PI: David Aboulafia, MD, CRC: Leila Ponce
A study to evaluate Diabetic Retinopathy in HIV subjects treated with EGRIFTA® | Study IDs: IRB12100 | PI: David
Aboulafia, MD, CRC: Leila Ponce | Sites: VMMC
AMC-085, Brentuximab Vedotin and Combination Chemotherapy in Treating Patients with Stage II-IV HIV-Associated
Hodgkin Lymphoma | Protocol ID: AMC 085, IRB13038, NCT01771107 | PI: David Aboulafia, MD, CRC: Leila Ponce
Leukemia
Connect MDS and AML: The Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML) Disease Registry
|Protocol ID: IRB13104, NCT01688011 | PI: David Aboulafia, MD, CRC: Leila Ponce
A Multicenter Phase 3 Randomized, Open-Label Study of Bosutinib versus Imatinib in Adult Patients with Newly
Diagnosed Chronic Phase Chronic Myelogenous Leukemia | Protocol ID: IRB14053, NCT02130557| PI: David Aboulafia,
MD, CRC: Leila Ponce
Lung
A Phase 2 Study of MM-121 in Combination with Docetaxel or Pemetrexed versus Docetaxel or Pemetrexed Alone in
Patients with Heregulin Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer | Protocol: IRB15016,
NCT02387216 | PI: Joseph Rosales, MD/ Leila Ponce
Phase Ib/II Trial of Carfilzomib with Irinotecan in Irinotecan-Sensitive Malignancies (Phase Ib) and Small Cell Lung
Cancer Subjects (Phase II) Who Have Progressed on Prior Platinum-Based Chemotherapy| Study IDs: IRB13025, | PI:
Kamal Chatta, MD, CRC: Emma Bishop
A Phase I, multi-center, randomized open label study to assess the systemic exposure and safety of 450 mg ceritinib
taken with a low-fat meal and 600 mg ceritinib taken with a low-fat meal as compared with that of 750 mg ceritinib
taken in the fasted state in adult patients with ALK rearranged (ALK-positive) metastatic non-small cell lung cancer
(NSCLC)| Protocol: IRB15025, NCT02299505| PI: Joseph Rosales, MD, CRC: Leila Ponce
A Randomized Phase 2, Double-blind, Placebo-controlled, Multi-center Study Comparing Pemetrexed in Combination
with TH-302 vs. Pemetrexed in Combination with Placebo as Second-line Chemotherapy for Advanced Non-Squamous
Non-Small Cell Lung Cancer| Study IDs: IRB14045.| PI: Kamal Chatta, MD, CRC: Leila Ponce
Safety and Efficacy of Abraxane in Combination with Carboplatin to Treat Advanced NSCL Cancer in the Elderly
(ABOUND 70+)| Study IDs: IRB14090, NCT02151149 | PI: Joseph Rosales, MD, CRC: Emma Bishop
Lymphoma
A Phase 2b Open-label, Randomized Two-arm Study of Selinexor (KPT-330) with Low Dose Dexamethasone in Patients
with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)| Protocol ID: IRB15003, NCT02227251 | PI: David
Aboulafia, MD, CRC: Emma Bishop
A Randomized, Open-Label, Phase 3 Trial of A+AVD Versus ABVD as Frontline Therapy in Patients With Advanced
Classical Hodgkin Lymphoma | Study IDs: IRB12128, NCT01712490| PI: David Aboulafia, MD, CRC: Leila Ponce
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Brentuximab Vedotin and CHP (A+CHP) vs CHOP in
the Frontline Treatment of Patients with CD30-Positive Mature T-Cell Lymphomas | Study IDs: IRB12077 | PI: David
Aboulafia, MD, CRC: Leila Ponce
A Phase II Trial of PET-Directed Therapy for Limited Stage Diffuse Large B-Cell Lymphoma (DLBCL) | Study IDs:
IRB13067, SWOG S1001 | PI: Prakash Vishnu, CRC: Kathy Rabena
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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Idelalisib (GS1101) in Combination with Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas | Study IDs: IRB14036
| PI: Prakash Vishnu, MD, CRC: Emma Bishop
A Sequential Phase I/Randomized Phase II Trial of Vorinostat and Risk-Adapted Chemotherapy with Rituximab in HIVRelated B-cell Non-Hodgkin’s Lymphoma | Protocol ID: IRB10139/ AMC-075, NCT01193842 | PI: David Aboulafia, MD,
CRC: Leila Ponce
Melanoma
A Multicenter, Double-blind, Placebo-controlled, Adaptive Phase 3 Trial of POL-103A Polyvalent Melanoma Vaccine in
Post-resection Melanoma Patients with a High Risk of Recurrence | Protocol ID: IRB14135, NCT01546571 | PI: Prakash
Vishnu, MD/ CRC: Kathy Rabena
A Randomized Phase II Trial of Intermittent Versus Continuous Dosing Of Dabrafenib (NSC-763760) and Trametinib
(NSC-763093) in BRAFV600E/K Mutant Melanoma | Protocol ID: IRB15017/ S1320, NCT02199730 | PI: Prakash Vishnu,
MD, CRC: Kathy Rabena
Myeloma
A Phase II Randomized Study Comparing Two Doses of Carfilzomib (NSC-756640) with Dexamethasone for Multiple
Myeloma Patients with Relapsed or Refractory Diseases |Study IDs: S1304, NCT01903811 |PI: Prakash Vishnu, MD,
CRC: Kathy Rabena
Pancreatic
Pancreatic Cancer Outcomes | Study IDs: BRI IRB12046, UW IR File # 7858 | PI: Theresa Brentnall MD/Vincent Picozzi
MD, CRC: Katherine Wilder
A Phase IIB, Randomized, Controlled, Multicenter, Open-Label Study of the Efficacy and Immune Response of GVAX
Pancreas Vaccine (with Cyclophosphamide) and CRS-207 Compared to Chemotherapy or to CRS-207 Alone in Adults
with Previously Treated Metastatic Pancreatic Adenocarcinoma | Study IDs: IRB13110 | PI: Vincent Picozzi MD, CRC:
Gretchen Sharp
An International, Multi-Center, Double-Blind, Randomized, Phase III Trial of 90Y-Clivatuzumab Tetraxetan plus LowDose Gemcitabine Versus Placebo plus Low-Dose Gemcitabine in Patients with Metastatic (Stage IV) Pancreatic
Adenocarcinoma Who Received at Least Two Prior Treatments (PANCRIT-1) | Study IDs: IRB13131 | PI: Vincent Picozzi
MD, CRC: Gretchen Sharp
Nab-paclitaxel and Gemcitabine vs Gemcitabine Alone as Adjuvant Therapy for Patients with Resected Pancreatic
Cancer (the "Apact" Study) (apact) | Study IDs: IRB14023 | PI: Vincent Picozzi MD, CRC: Gretchen Sharp
Evaluating Health-Related Quality of Life among Patients Treated with Abraxane and Gemcitabine for Metastatic
Pancreatic Cancer: A Pilot Study | IRB14064 | PI: Vincent Picozzi, MD, CRC: Katherine Wilder
A Randomized, Double-Blind, Phase 3 Study of the JAK 1/2 Inhibitor, Ruxolitinib or Placebo in Combination With
Capecitabine in Subjects With Advanced or Metastatic Adenocarcinoma of the Pancreas Who Have Failed or Are
Intolerant to First-Line Chemotherapy (The JANUS 2 Study) | Protocol ID: IRB14091, NCT02119663 | PI: Vince Picozzi,
MD/ CRC: Gretchen Sharp
A Randomized, Open Label, Phase 2 Trial of Gemcitabine plus Nab-paclitaxel with or without FG-3019 as Neoadjuvant
Chemotherapy in Locally Advanced, Unresectable Pancreatic Cancer | Study IDs: IRB14038 | PI: Vincent Picozzi MD,
CRC: Gretchen Sharp
Prostate
The Men’s Eating and Living (MEAL) Study: A Randomized Trial of Diet to Alter Disease Progression in Prostate Cancer
Patients on Active Surveillance| Study IDs: IRB11034, CALGB 70807, NCT01238172 | PI: John Corman, CRC: Zoya Hyder
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A Phase III Prospective Randomized Trial of Dose-Escalated Radiotherapy With or Without Short-Term Androgen
Deprivation Therapy for Patients With Intermediate-Risk Prostate Cancer | Study IDs: RTOG 0815, NCT00936390 | PI:
Huong Pham, MD, CRC: Zoya Hyder
Androgen Deprivation Therapy and High Dose Radiotherapy With or Without Whole-Pelvic Radiotherapy in
Unfavorable Intermediate or Favorable High Risk Prostate Cancer | Study IDs: RTOG 0924, IRB11135, NCT01368588 |
PI: Huong Pham, MD, CRC: Zoya Hyder
Surgery With or Without Docetaxel and Leuprolide or Goserelin in Treating Patients With High-Risk Localized Prostate
Cancer | Study IDs: CALGB 90203, NCT00430183 | PI: John Corman, MD, CRC: Zoya Hyder
A Phase 3 Randomized, Placebo-controlled Double-blind Study of JNJ-56021927 in Combination with Abiraterone
Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects with Chemotherapy-naive Metastatic
Castration-resistant Prostate Cancer (mCRPC) | Protocol ID: IRB14146, NCT02257736 | PI: Kamal Chatta, MD, CRC:
Zoya Hyder
Detection of Gleason Grade-Specific Transcripts in Urine, Prostatic Tissue and Blood Serum in Men with Prostate
Cancer Undergoing Saturation Biopsy or Surgery| Study IDs: IRB13066| PI: Christopher Porter, CRC: Debbie Sparks
SPARTAN: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men with
Non-Metastatic (M0) Castration-Resistant Prostate Cancer| Study IDs: IRB14058, NCT01946204| PI: Kamal Chatta, MD,
CRC: Zoya Hyder
A Randomized, Double-blind, Multicenter, Parallel-Group , Phase III Study to Evaluate Efficacy and Safety of
DCVAC/PCa versus Placebo in Men with Metastatic Castration Resistant Prostate Cancer Eligible for 1st Line
Chemotherapy| Study IDs: IRB13101, NCT02111577| PI: John Corman, MD, CRC: Kathryn Dahl
Renal
An International Phase 3 Randomized Trial of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard
Treatment of Advanced Renal Cell Carcinoma (ADAPT)| Study IDs: NCT01582672, IRB12136| PI: Kamal Chatta, MD,
CRC: Zoya Hyder
EVEREST: EVErolimus for Renal Cancer Ensuing Surgical Therapy, A Phase III Study| Study IDs: S0931| PI: Kamal Chatta,
MD, CRC: Zoya Hyder
A Multicenter, Open-label, Phase 1b/2 Study to Evaluate the Safety and Efficacy of RX-0201 in Combination With
Everolimus to Treat Subjects With Advanced Renal Cell Carcinoma| Study IDs: IRB14040, NCT02089334| PI: Kamal
Chatta, MD, CRC: Zoya Hyder
Teratoma
A randomized, blinded, placebo-controlled, phase II trial of LEE011 in patients with relapsed, refractory, incurable
teratoma with recent progression | Protocol ID: IRB14084, NCT02300987 | PI: Craig Nichols, MD, CRC: Leila Ponce
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(206) 342-6954 | Email: [email protected]