Clinical Research Protocols
BLADDER
11/95 Multi-modality Treatment of Bladder Cancer: Laparascopic Surgical Staging, Neoadjuvant Cisplatin/Taxol,
External Beam Radiation Therapy and Salvage Cystectomy
Investigator Initiated
Protocol Number J9538. Closed to Accrual
Approved, The Johns Hopkins University Joint Committee on Clinical Investigation
Co-investigator
4/96 A Phase II trial of Gemcitabine Plus Cisplatin Combination Therapy in Chemonaive Patients with
Metastatic Urothelial Cancer
Industry Sponsored- Eli Lilly
Protocol Number J9622, Completed Accrual
Approved, The Johns Hopkins University Joint Committee on Clinical Investigation
Principal Investigator
4/97 An ECOG Multicenter Phase II Trial of Paclitaxel and Carboplatin in Metastatic Urothelial Cancer.
National Trial
Protocol Number E2896, Completed accrual
Approved, The Johns Hopkins University Joint Committee on Clincial Investigation
Principal Investigator
9/97 A Phase II, Open Label Study of Oral Piritrexim in Patients with Advanced Carcinoma of the
Urothelium Who Have Failed Standard Chemotherapy
Industry Sponsored- Ilex Oncology
Protocol Number J9728., Completed Accrual.
Approved, The Johns Hopkins University Joint Committee on Clinical Investigation, 9/97 Completed.
Principal Investigator
8/98 A Phase II Trial of Gemcitabine Plus Paclitaxel Combination Therapy in Patients with Locally
Advanced or Metastatic Urothelial Cancer
Industry sponsored- Eli Lilly
Protocol Number J9846. Completed Acrual
Approved, The Johns Hopkins University Joint Committee on Clinical Investigation
Principal Investigator
3/00 A Phase III Randomized Trial of Either M-VAC or Carboplatin + Paclitaxel As Postoperative
Adjuvant Therapy in Patients with Muscle-Invasive Transitional Cell Carcinoma of the Bladder at
High-Risk for Relapse.
National Trial
Protocol Number E1897, Closed nationally for low accrual.
Approved, The Johns Hopkins University Joint Committee on Clinical Investigation
Principal Investigator
2/01 A Phase IIa Study of the Efficacy of J-107088 in Patients with Metastatic Urothelial Transitional Carcinoma
Industry sponsored- Merck-Banyu
Protocol Number J0079- Banyu Protocol RC749J204-00. Completed accrual
Approved, The Johns Hopkins University Joint Committee on Clinical Investigation
Principal Investigator
PHASE I
Open Trials
8/05 A phase 1, open-label, multicenter, dose escalation study of the safety and pharmacokinetics of
AGS-PSCA given as monotherapy in subjects with advanced prostate cancer.
Industry sponsored, Agensys
Protocol Number J0554, Completed accrual.
Approved, Western Institutional Review Board
Principal Investigator
1/06 A Phase 1 Dose-Escalation Study of LY2157299 in Patients with Advanced or Metastatic Cancer
(Protocol H9H-MC-JBAH)
Industry sponsored, Eli Lilly
Protocol Number J0583, Ongoing
Approved, Western Institutional Review Board
Principal Investigator
9/06 A phase I study of BMS 641988 in patients with hormone refractory prostate cancer
Industry sponsored, Bristol Myers Squibb
Protocol Number J0614, Closed for toxicity
Approved, Johns Hopkins University Institutional Review Board.
Principal Investigator
11/06 A Phase I safety evaluation of oral enzastaurin in combination with bevacizumab in "
patients with advanced/metastatic cancer
Investigator Initiated, Industry sponsored – Eli Lilly
Protocol Number J0688, Ongoing
Approved, Johns Hopkins University Institutional Review Board
Principal Investigator
11/06 A Phase I open-label, multi-center dose-escalation study to assess the safety,
tolerability, and pharmacokinetics of AZD7762 adminsitered as a single agent and in combination
with weekly standard dose gemcitabine in patients with advanced solid malignancies
Industry sponsored- Astra Zeneca
Protocol Number J06101, Ongoing
Approved, Johns Hopkins University Institutional Review Board.
Principal Investigator
1/07 A Phase I trial of CEP-11981 in advanced solid tumor malignancies
Industry-sponsored, Cephalon
Protocol Number J0719, Ongoing
Approved, Johns Hopkins University Institutional Review Board
Principal Investigator
6/09 A Phase I trial on AMG-900 in advanced solid tumor malignancies
Industry-sponsored, AMGEN
Protocol Number J0915, Pending
Approved, Johns Hopkins University Institutional Review Board
Principal Investigator
Completed Clinical Trials
8/94 A Phase I Clinical and Pharmacologic Evaluation of Intravenous Phenylbutyrate in Patients with
Refractory Solid Tumors Given as 120-hour Infusion
Investigator Initiated- NCI sponosr
Protocol Number J9502. Completed accrual
Approved, The Johns Hopkins University Joint Committee on Clinical Investigation
Principal Investigator
3/96 A Phase I Clinical and Pharmacologic Evaluation of Oral Phenylbutyrate in Patients with
Refractory Solid Tumors on a Three Times Daily Schedule
Investigator Initiated- NCI sponsor
Protocol number J9616. Completed accrual
Approved, The Johns Hopkins University Joint Committee on Clinical Investigation
Principal Investigator
4/97 A Phase I Clinical and Pharmacological Evaluation of ABT-627 in Patients with Refractory Adenocarcinomas.
Investigator initiated, Industry sponsored- Abbott Laboratories
Protocol Number J9715- completed accrual
Approved, The Johns Hopkins University Joint Committee on Clinical Investigation
Principal Investigator
4/97 A Phase I Clinical and Pharmacological Evaluation of Phenylbutyrate in Patients with
Refractory CNS Tumors.
Investigator Initiated - New Approaches to Brain Tumor Therapy Consortium,
Protocol Number N9607. Completed accrual.
Approved, The Johns Hopkins University Joint Committee on Clinical Investigation
Principal Investigator
12/97 Phase I Study of Oral Piritrexim with Intravenous Gemcitabine in Patients with Advanced Solid
Tumors and Varying Degrees of Renal Function
Investigator Initiated, Industry sponsored- ILEX oncology. Completed accrual
Approved, The Johns Hopkins University Joint Committee on Clinical Investigation
Principal Investigator
1/00 Phase I Dose Escalation to Maximally Tolerated Dose Trial of 5-Azacytidine in Combination with
Sodium Phenylbutyrate in Patients with Refractory Solid Tumors
Investigator Initiated- NCI sponsor
Protocol Number J9982, Completed accrual
Approved, The Johns Hopkins University Joint Committee on Clinical Investigation
Principal Investigator
2/01 A Phase I Dose Escalation and Pharmacokinetic Evaluation of LY-317615
Industry sponsored- Eli Lilly
Protocol Number J0080. Completed accrual.
Approved, The Johns Hopkins University Joint Committee on Clinical Investigation
Principal Investigator
5/04 A Phase I Study of MGCD0103 Given as a Three Times Weekly Oral Dose in Patients with
Advanced Solid Tumors or Non-Hodgkin’s Lymphoma
Industry sponsored- Methylgene
Protocol Number J0411, completed accrual
Approved, Johns Hopkins University Institutional Review Board
Principal Investigator
5/04 A Phase I study of Mitoxantrone in combination with OSI-461 in patients with Advanced Malignancies
Industry sponsored, OSI Pharmaceuticals
Protocol Number J0422, Completed accrual
Approved, Johns Hopkins University Institutional Review Board
Principal Investigator
1/06 A phase I, randomized multicenter double-blind study of MK-0429 in the treatment of men
with hormone refractory prostate cancer and metastatic bone disease
Industry sponsored, Merck
Protocol Number J05114 Completed Accrual.
Approved, Western Institutional Review Board
Principal Investigator
8/07 A Phase I trial of MGCD-0103 and Docetaxel in advanced solid tumors
Industry sponsored, Pharmion
Protocol Number J0722, Closed secondary to company decision
Approved, Johns Hopkins University Institutional Review Board
Principal Investigator
PROSTATE
Open Clinical Trials
11/05 A Pharmacodynamic Study of Pre-Prostatectomy Rapamycin in Advanced Localized
Prostate Cancer Investigator Initiated
Protocol Number J0576, Completed accrual as planned
Approved, Johns Hopkins University Institutional Review Board
Principal Investigator
12/05 CALGB 90401- A Randomized double-blinded placebo controlled Phase III trial comparing
Docetaxel and prednisone with and without Bevacizumab (IND #7921, NSC #704865)
in Men with Hormone
Refractory Prostate Cancer
National Trial
Protocol Number ECALGB90401, Closed to Accrual- Patients in follow-up
Approved, CIRB
Principal Investigator/ ECOG Study Chair
10/06 A randomized phase II study of two dose levels of ATN-224 in patiens with biochemically relapsed,
hormone-naïve prostate cancer
Investigator contribution, Industry sponsored- Attenuon
Protocol Number J0667, Closed to Accrual, Patients in follow-up
Approved, Johns Hopkins University Institutional Review Board
Principal Investigator/ Study Chair
1/07 E3805 CHAARTED: ChemoHormonal Therapy versus Androgen Ablation Randomized Trial for
Extensive Disease in Prostate Cancer
National Trial
Protocol Number E3805, Ongoing
Approved, CIRB
Principal Investigator
8/07 A phase I trial of AGS16M18 in hormone refractory prostate cancer
Industry Sponsored, Merck
Protocol Number J0749, Closed to Accrual
Approved, Johns Hopkins University Insitutional Review Board
Principal Investigator/Study Chair
2/08 Phase III Trial of Denosumab versus Zolendronic Acid in Men with Metastatic Hormon
Refractory Prostate Cancer
Industry Sponsored, Amgen
Protocol Number J07108, Closed to accrual, patients in follow-up
Approved, Johns Hopkins University Institutional Review Board
Principal Investigator/ Study Chair
2/08 Randomized Double Blind Study of the Effects of Two Doses of POMx on Rising PSA in
Patients Post-Local Therapy for Prostate Cancer
Investigator Initiated, Industry Sponsored, POM Wonderful
Protocol Number J0791, Ongoing
Approved, Johns Hopkins University Institutional Review Board
Principal Investigator/ Study Chair
7/08 Phase III study of docetaxel and atrasentan versus docetaxel and placebo for patients with
advanced hormone refractory prostate cancer
National, Cooperative Group
SWOG 0421, Ongoing
Approved, Johns Hopkins University Institutional Review Board
Principal Investigator/ECOG Study Chair
9/08 Randomized Open Label Multicenter Phase III Study of Androgen Deprivation with
Leuprolide +/- Docetaxel for Clinically Asymptomatic Prostate Cancer Subjects with a Rising
PSA Following Definitive Local Therapy
Industry Sponsored, Sanofi-Aventis
Protocol Number J0788, Ongoing
Approved, Johns Hopkins University Institutional Review Board
Principal Investigator
9/08 Phase III randomized, placebo controlled double blind study to assess the efficacy
and safety of once-daily orally administered ZD4054 10mg in non-metastatic hormone resistant
prostate cancer patients
Industry Sponsored, AstraZeneca
Protocol Number J0814, Ongoing
Approved, Johns Hopkins University Institutional Review Board
Principal Investigator
1/09 Effect of POMx extract tablets on biomarkers: A preprostatectomy study
Investigator Initiated, POM Wonderful/DOD
Protocol Number J0846, Ongoing
Approved, Johns Hopkins University Institutional Review Board
Principal Investigator
6/09 Phase I /II trial of vorinostat and temsirolimus in castrate resistant prostate cancer
Investigator-initiated, SPORE Science
Protocol Number- J0874, Pending
Approved, Johns Hopkins University Institutional Review Board
Principal Investigator
6/09 Multi-modality study of Sunitinib and DOcetaxel in men undergoing salvage radiotherapy for prostate cancer
Investigator-Initiated, Duke/DOD
Protocol Number- J0910, Pending
Approved, Johns Hopkins University Institutional Review Board
Principal Investigator
6/09 Phase II trial of two doses of itraconazole in chemo-niave men with castrate resistant
metastatic prostate cancer
Investigator- Initiated, Commonwealth Foundation
Protocol Number- J0915, Pending
Approved, Johns Hopkins University Institutional Review Board
Principal Investigator
6/09 Phase II study of short course androgen deprivation with or without bevacizumab in men with a
rising PSA after local therapy
Investigator- Initiated, DFCI/DOD
Protocol Number- J0906, Pending
Approved, Johns Hopkins University Insitutional Review Board
Principal Investigator
Completed Clinical Trials
8/94 Phase I/II Study of Autologous Human GM-CSF Gene Transduced Prostate Cancer Vaccines in
Patients with Metastatic Prostate Carcinoma
Investigator Initated
Protocol Number J9424. Completed accrual
Approved, NIH Recombinant DNA Advisory Committee
Co-investigator.
9/96 A Multicenter Phase 2 Evaluation of Targretin Capsules (LGD 1069) in Patients with Metastatic,
Androgen-independent Prostate Cancer
Industry sponsored, Ligand Pharmaceuticals
Protocol Number J9645. Completed accrual
Approved, The Johns Hopkins University Joint Committee on Clinical Investigation
Principal Investigator
4/97 An International Phase II Randomized, Double- blind, Multicenter Study to Determine the Tolerability
and Efficacy of Three Different Doses of Liarozole in Patients with Rising Prostate Specific Antigens
Levels after Definitive Treatment
Industry sponsored, Jannsen Pharmaceuticals
Protocol Number J9707. Completed.accrual
Approved, The Johns Hopkins University Joint Committee on Clinical Investigation
Principal Investigator
2/98 Dose Ranging Study Comparing Best Medical Therapy With and Without ABT-627 for the Treatment of
Men with Asymptomatic Hormone Refractory Prostate Cancer
Industry sponsored, Abbott Laboratories
Protocol Number J9804 Completed accrual
Approved, The Johns Hopkins University Committee on Clinical Investigation
Principal Investigator
2/98 Dose Ranging Study Comparing Best Medical Therapy With and Without ABT-627 for the
Treatment of Pain in Men with Symptomatic Hormone Refractory Prostate Cancer
Industry sponsored, Abbott Laboratories
Protocol Number J9805 Completed accrual
Approved, The Johns Hopkins University Joint Committee on Clinical Investigation
Principal Investigator
1/99 A Phase II Study of CT 2584 Mesylate in Patients with Hormone Refractory Prostate Cancer.
Industry sponsored, Cell Therapeutics
Protocol Number J9870 Completed accrual
Approved, The Johns Hopkins University Joint Committee on Clinical Investigation
Principal Investigator
1/00 A Randomized, Placebo-Controlled Trial of Celecoxib in Men Pre-prostatectomy for
Clinically Localized Adenocarcinoma of the Prostte: Evaluation of Drug-specific Biomarker Modulation.
Investigator Initiated, NCI sponsor
Protocol Number J0007, completed accrual
Approved, The Johns Hopkins University Joint Committee on Clinical Investigation
Principal Investigator
7/02 A Phase III Randomized Trial for Evaluating Two Distinct Treatment Regimens on Progression
Free Survival in Asymptomatic Patients with a Rising PSA After Hormonal Therapy for Prostate Cancer
Investigator Initiated, ECOG sponsor
Protocol Number E1899 Closed nationally secondary to poor accrual
Approved, Central Institutional Review Board
Principal Investigator/ Study Chair.
7/00 A Phase I/II Dose Finding Trial of the Intravenous Injection of Calydon CV787, A Prostate-Specific Antigen Cytolytic Adenovirus, in Patients with Hormone Refractory Prostate Cancer
Investigator Initiated, Industry sponsored, Calydon Corporation
Protocol Number Completed accrual
Approved, The Johns Hopkins Joint Committee on Clinical Investigation
Principal Investigator.
12/00 A Multi-center, Non-randomized, Open Label Phase II Study Evaluating Docetaxel Plus
Exisulind in Patients with Hormone Refractory Prostate Cancer
Investigator initiated, industry sponsored
Protocol Number Completed accrual
Approved, The Johns Hopkins Joint Committee on Clinical Investigation
Principal Investigator
2/01 A Phase II Open-label Study of Taxoprexin Injection by 2-hour Intravenous Infusion in
Patients with Metastatic, Hormone Refractory Prostate Cancer
Industry sponsored, Protarga
Protocol Number J0092, Completed accrual
Approved, The Johns Hopkins Joint Committee on Clinical Investigation
Principal Investigator
11/01 Phase III Randomized, Double-blind, Placebo Controlled Study of Safety, Efficacy of 10mg
Atrasentan in Men with Metastatic, Asymptomatic, Hormone Refractory Prostate Cancer.(Abbott M00-211)
Industry sponsored, Abbott Laboratories
Protocol Number J0142, Completed accrual
Approved, Western Institutional Review Board
Principal Investigator/ Study Chair.
11/01 Phase III Randomized, Double-blind, Placebo Controlled Study of Safety, Efficacy of 10mg Atrasentan in
Men with Nonmetastatic, Hormone Refractory Prostate Cancer (Abbott M00-244)
Industry Sponsored, Abbott Laboratories
Protocol Number J0143, Completed accrual
Approved, Western Institutional Review Board
Principal Investigator/ Study Chair
11/01 A Phase III Extension Study to Evaluate the Safety of Atrasentan in Men with Hormone Refractory
Prostate Cancer. (Abbott M00-258)
Industry sponsored, Abbott Laboratories
Protocol Number J0144, Completed accrual
Approved, Western Institutional Review Board
Principal Investigator
3/03 A Phase II Study Evaluating the Efficacy of Atrasentan (ABT-627) in Men with Hormone Naive Prostate Cancer who are Exhibiting Early Signs of Biochemical Failure(Abbott – M01-366)
Industry sponsored, Abbott Laboratories
Protocol Number J0219, Completed accrual
Approved, Johns Hopkins University Institutional Review Board
Principal Investigator
11/02 A randomized Phase II study of Docetaxel and DN-101 in Hormone Refractory Prostate Cancer
Industry sponsored, Novacea
Protocol Number J0235, Completed accrual
Approved, Western Institutional Review Board
Principal Investigator
3/04 Docetaxel with Rapid Hormonal Cycling as a Treatment for Patients with Prostate Cancer
Investigator initiated, Industry Supported
Protocol Number J0335, completed accrual
Approved JH IRB #2
Principal Investigator
11/06 A phase II study of CGC-11047 in patients with metastatic hormone refractory prostate cancer
Industry Sponsored, DOD supported - Cellgate
Protocol Number J0653, Closed secondary to financial stability of company
Approved, Johns Hopkins University Institutional Review Board
Principal Invesigator
1/06 A phase II study cilingetide in men with non-metastatic hormone refractory prostate cancer
Investigator Initiated
Protocol Number J0608, closed by sponsor for lack of efficacy
Approved, Johns Hopkins University Institutional Review Board
Principal Investigator
1/06 E5803, A Phase II Trial of GW572016 in Patients with Recurrent Prostate Cancer as Evident
By a Rising PSA
National Trial
Protocol Number E5803, Closed to accrual
Approved, Western Institutional Review Board
Principal Investigator
11/06 A phase II trial of Dasatinib in hormone refractory prostate cancer
Industry sponsored, Bristol Myers Squibb
Protocol Number J06132, Complete
Approved, Johns Hopkins University Institutional Review Board
Principal Investigator
RENAL
1/05 A Phase I/II trial of SAHA in combination with bevacizumab in advanced renal cell cancer
Investigator- Intiatied, UO1 grant supported
Protocol Number J0570, Ongoing
Approved, Johns Hopkins University Institutional Review Board
Principal Investigator
12/08 E2805- ASSURE Study- Adjuvant Sorafenib, Sunitinib or Placebo for resected Renal Cell Cancer
National Study, ECOG
Protocol Number E2805, Ongoing
Approved, Central IRB
Principal Investigator
12/08 Phase I study of AGS-16M18 in metastatic renal cell cancer
Industry-sponosred, Agensys
Protocol Number J0818, Ongoing
Approved, Johns Hopkins Institutional Review Board
Principal Investigator
7/09 Phase I/II study of LBH-589 in combination with Everolimus in advanced renal cell cancer
Investigator-Initiated, Novartis
Protocol Number J0862, Pending
Approved, Johns Hopkins Insitutional Review Board
Principal Investigator
6/09 Phase II dose ranging study of Axitinib in patients with advanced renal cell cancer
Industry-sponsored, Pfizer
Protocol Number J09
Approved, Johns Hopkins Institutional Review Board
Principal Investigator
8/09 Phase I /II study of MS-275 and Interleukin-2 in advanced renal cell cancer
Investigator-initiated, UO1
Protocol Number J0841, Pending
Approved, Johns Hopkins Institutional Review Board
Principal Investigator
