The James Buchanan Brady Urological Institute
 
 
 
Michael A. Carducci, MD Michael A. Carducci, M.D., FACP
Professor in Oncology and Urology
Johns Hopkins Medical Institutions

Email:carducci@jhmi.edu

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

 



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