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PROTOCOL ALERT

PROTOCOL ALERT

doi: 10.1097/01.COT.0000290049.42382.b4
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The following is a partial list of new clinical trials recently added to the NCI's Physician Data Query (PDQ) database, accessible online at www.cancer.gov (Click on “Clinical Trials”).

Gynecologic Cancer

108052 (FU month 18), NCT00359619

Human Papillomavirus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Biologicals' Novel HPV Vaccine

Age: 18 to 25

Sponsor: Pharmaceutical/Industry

STUDY LEAD ORGANIZATION

GlaxoSmithKline

GSK Clinical Trials Call Center; Ph: 877-379-3718

107921 (FU month 36), NCT00359827

Human Papillomavirus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Biologicals' Novel HPV Vaccine

Age: 18 to 25

Sponsor: Pharmaceutical/Industry

STUDY LEAD ORGANIZATION

GlaxoSmithKline

GSK Clinical Trials Call Center; Ph: 877-379-3718

NOV002-IS21-OC, NCT00345540

Efficacy of NOV-002 in Combo with Carboplatin in Chemo-Resistant Ovarian Cancer

Age: 18 and over

Sponsor: Pharmaceutical/Industry

STUDY LEAD ORGANIZATION

Novelos Therapeutics Incorporated

Massachusetts General Hospital Cancer Center

Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute

Maria Roche, RN, NP; Ph: 617-724-4800; Email: mroche@partners.org

UMN-2006LS005, UMN-0601M80926, UMN-MT2006-02, NCT00319748

Phase II Study of 852A in Patients With Refractory Metastatic Breast, Ovarian, Endometrial, or Cervical Cancer

Age: Over 18

Sponsor: NCI

STUDY LEAD ORGANIZATION

University of Minnesota Cancer Center

Sarah Cooley, MD, Protocol chair; Ph: 612-625-8474, 888-226-2376

1547-851B, NCT00312286

Effectiveness of 851B Gel for the Treatment of High-Risk Cervical Human Papillomavirus (HPV) Infection

Age: 18 to 40

Sponsor: Pharmaceutical/Industry

STUDY LEAD ORGANIZATION

3M Pharmaceuticals

Takeda Pharmaceuticals North America Incorporated

Central Contact; Ph: 800-814-1795

Head and Neck Cancer

CHUV-CEPO-161-05, EU-20627, NCT00357617

Phase I/II Study of Celecoxib in Patients with Resectable Head and Neck Squamous Cell Carcinoma

Age: 18 and over

Sponsor: Other

STUDY LEAD ORGANIZATION

Centre Hospitalier Universitaire Vaudois

Francois Luthi, MD, Protocol chair; Ph: 41-213-140-155

1839IL/0547, NCT00228488

Effect of Iressa With/Without Concurrent Chemoradiotherapy on Tumor Gene Expression Profiles in Patients with Advanced Non-Nasopharyngeal Head and Neck Carcinoma

Age: 18 and over

Sponsor: Pharmaceutical/Industry

STUDY LEAD ORGANIZATION

AstraZeneca Pharmaceuticals LP

AstraZeneca Hong Kong; Ph: 852-2420-7388

06U.195, NCT00358007

Use of Cone Beam Kilovaltage Imaging in Patients Receiving Radiation Therapy for Head and Neck Cancer

Age: 18 and over

Sponsor: Other

STUDY LEAD ORGANIZATION

Kimmel Cancer Center at Thomas Jefferson University, Philadelphia

Mitchell Machtay, MD, Principal Investigator; Ph: 215-955-6706; Email: roseann.bonanni@mail.tju.edu

ARQ 501–208, NCT00358930

A Phase 2 Study of ARQ 501 in Patients with Squamous Cell Carcinoma of the Head and Neck

Age: 18 and over

Sponsor: Pharmaceutical/Industry

STUDY LEAD ORGANIZATION

ArQule Incorporated; Ph: 781-994-0300; Email: arquleclinical@arqule.com

RTOG-0435, NCT00360971

Phase III Randomized Study of Palifermin for Reducing Oral Mucositis in Patients With Locally Advanced Squamous Cell Carcinoma of the Oral Cavity, Oropharynx, Hypopharynx, or Larynx Undergoing Concurrent Radiotherapy and Chemotherapy

Age: 18 and over

Sponsor: NCI

STUDY LEAD ORGANIZATION

Radiation Therapy Oncology Group

David Rosenthal, MD, Protocol chair; Ph: 713-563-2300, 800-392-1611; Email: dirosenthal@mdanderson.org

Hematologic Malignancies

20050100, NCT00352703

PROMPT—Palifermin in Reduction of Oral Mucositis in PBSC Transplantation

Age: 18 and over

Sponsor: Pharmaceutical/Industry

STUDY LEAD ORGANIZATION

Amgen Incorporated

Amgen Call Center; Ph: 866-572-6436

EudraCT: 2005-000805-68, NCT00354120

Thymoglobuline Versus Alemtuzumab in Patients Undergoing Allogeneic Transplant

Age: 18 to 65

Sponsor: Other

STUDY LEAD ORGANIZATION

Gruppo Italiano Trapianto di Midollo Osseo

Roberto Marchioli, MD; Ph: 39-0872-570324; Email: marchioli@negrisud.it

HOD05, NCT00352027

Chemotherapy with Low-Dose Radiation for Pediatric Hodgkin's Disease

Age: 21 and under

Sponsor: Other

STUDY LEAD ORGANIZATION

St. Jude Children's Research Hospital

Massachusetts General Hospital Cancer Center

Maine Medical Center, Bramhall Campus

Stanford Cancer Center at Stanford University Medical Center

Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute

Monika Metzger, MD, Principal Investigator; Ph: 866-278-5833; Email: info@stjude.org

TSRCC-164-2006, NCT00363090

Phase I/II Study of Alemtuzumab in Combination With Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine, and Prednisone (CHOP) Chemotherapy in Patients With Newly Diagnosed, Stage II-IV Aggressive Peripheral T-Cell Non-Hodgkin's Lymphoma

Age: 18 and over

Sponsor: Other

STUDY LEAD ORGANIZATION

Toronto Sunnybrook Regional Cancer Centre at Sunnybrook Health Sciences Centre

Rena Buckstein, MD, Protocol chair; Ph: 416-480-5847; Email: rena.buckstein@sunnybrook.ca

BMT183, NCT00349778, IRB e-protocol 5704

High-Dose Sequential Therapy and Single Autologous Transplantation for Multiple Myeloma

Age: 18 to 75

Sponsor: Other

STUDY LEAD ORGANIZATION

Stanford Cancer Center at Stanford University Medical Center

BMT Referrals; Ph: 650-723-0822

AME 06.133v.A, NCT00354926

Safety and Efficacy Study of an Anti-CD20 Monoclonal Antibody (AME-133v) to Treat Non-Hodgkin's Lymphoma

Age: 18 and over

Sponsor: Pharmaceutical/Industry

STUDY LEAD ORGANIZATION

Applied Molecular Evolution

Susan Carpenter, PhD; Ph: 858-597-4990; Email: carpentersu@lilly.com

UMN-2005LS075, UMN-0511M77206, UMN-MT2005-25, NCT00357565

Phase II Study of a Myeloablative Conditioning Regimen Comprising Busulfan, Fludarabine Phosphate, and Melphalan Followed By Donor Umbilical Cord Blood Transplantation in Infants with High-Risk Acute Leukemia or Myelodysplastic Syndromes

Age: 2 and under at diagnosis

Sponsor: NCI

STUDY LEAD ORGANIZATION

University of Minnesota Cancer Center

Michael Verneris, MD, Protocol chair; Ph: 612-626-2961, 888-226-2376; Email: verneris@umn.edu

CCC-PHII-68, CHNMC-PHII-68, NCT00357032, NCI-7265

Phase II Study of PXD101 in Patients with Relapsed or Refractory Acute Myeloid Leukemia or in Older Patients with Newly Diagnosed Acute Myeloid Leukemia

Age: 18 and over

Sponsor: NCI

STUDY LEAD ORGANIZATION

California Cancer Consortium

Kenneth Foon, MD, Protocol chair; Ph: 412-648-6589; Email: foonka@upmc.edu

MSKCC-05059, NCT00357396

Phase II Study of a Myeloablative Regimen Comprising Busulfan, Melphalan, and Thiotepa Followed By Allogeneic Hematopoietic Stem Cell Transplantation in Patients With High-Risk Tumors of the Ewing's Family

Age: 40 and under

Sponsor: Other

STUDY LEAD ORGANIZATION

Memorial Sloan-Kettering Cancer Center

Susan Prockop, MD, Protocol chair; Ph: 212-639-6715, 800-525-2225

FHCRC-1978.00, NCT00357084

Phase II Study of Methotrexate and Glucocorticoids in Treating Newly Diagnosed Acute Graft-Versus-Host Disease in Patients Who Have Undergone Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation

Study: Any age

Sponsor: NCI

STUDY LEAD ORGANIZATION

Fred Hutchinson Cancer Research Center

Marco Mielcarek, MD, Protocol chair; Ph: 206-667-2827

CASE-4202, CASE-RDN-5402, NCT00360776, NCI-6823

Phase II Study of Tipifarnib in Patients with Large Granular Lymphocyte Leukemia Who Present with Anemia or Neutropenia

Age: 18 and over

Sponsor: NCI

STUDY LEAD ORGANIZATION

Case Comprehensive Cancer Center

Thomas Loughran, MD, Protocol chair; Ph: 717-531-1078; Email: tloughran@psu.edu

Liver Cancer

LSO-OL005, NCT00355355

A Phase 3 Study of Talaporfin Sodium and Interstitial Light-Emitting Diodes Treating Hepatocellular Carcinoma (HCC)

Age: 18 and over

Sponsor: Pharmaceutical/Industry

STUDY LEAD ORGANIZATION

Light Sciences Corporation

Sar Har Luk, MD, Principal Investigator; Ph: 852-2468-5174; Email: luksh@ha.org.hk

Beatrice Jayme-Tiangco, MD, Principal Investigator; Ph: (632) 635-6789; Email: tixietiangco@yahoo.com

SiLVER05, NCT00355862, 2005-005362-36

Immunosuppression in Patients Undergoing Liver Transplantation for Hepatocellular Carcinoma

Age: 18 and over

Sponsor: Other

STUDY LEAD ORGANIZATION

Klinikum der Universitaet Regensburg

Edward K. Geissler, PhD, Study chair; Ph: 49-941-944-6964; Email: edward.geissler@klinik.uni-regensburg.de

Andreas A. Schnitzbauer, MD; Ph: 49-941-944-6770; Email: andreas.schnitzbauer@klinik.,uni-regensburg.de

07-2006, NCT00357422

Comparison Study of Operation and Percutaneous Ethanol Injection Therapy for Small, Solitary HCC

Age: 20 to 70

Sponsor: Other

STUDY LEAD ORGANIZATION

Seoul National University Hospital

J.H. Yoon, Principal Investigator; Ph: 82-2-2072-2228; Email: yoonjh@snu.ac.kr

07-2006-010, NCT00357474

Comparison Study of Transarterial Chemoembolization and Percutaneous Ethanol Injection for Multiple, Small HCCs

Age: 20 to 70

Sponsor: Other

STUDY LEAD ORGANIZATION

Seoul National University Hospital

H.S. Lee; Ph: 82-2-2072-2228; Email: hsleemd@snu.ac.kr

MAYO-MC0441, NCT00365391

Phase II Study of Bevacizumab and Erlotinib Hydrochloride in Patients With Advanced Hepatocellular Cancer

Age: 18 and over

Sponsor: NCI

STUDY LEAD ORGANIZATION

Mayo Clinic Cancer Center

Philip Philip, MD, PhD, FRCP, Protocol chair; Ph: 313-576-8728, 800-527-6266; Email: philipp@karmanos.org

Lung Cancer

CA165-026, NCT00359450, EUDRACT: 2005-005099-33

A Phase II Study of BMS-275183 in Patients with Pretreated Local Advanced or Metastatic NSCLC (Non-Small-Cell Lung Cancer)

Age: 18 and over

Sponsor: Pharmaceutical/Industry

STUDY LEAD ORGANIZATION

Bristol-Myers Squibb Company, New York

BMS Call Center; Ph: 866-892-1BMS, ext. 392

BMS Call Center Outside the US & Canada; Ph: 941-906-4711, ext. 392

MCC#14659, NCT00351039

Phase I/II Trial of Bevacizumab, Pemetrexed, and Erlotinib in Elderly Patients with Non-Small-Cell Lung Cancer

Age: 70 and over

Sponsor: Other

STUDY LEAD ORGANIZATION

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

Genentech Incorporated

Eli Lilly and Company

Aaron Becker, RN; Ph: 813-745-4679; Email: beckerad@moffitt.usf.edu

George R. Simon, MD; Ph: 813-745-3530; Email: simongr@moffitt.usf.edu

20131, NCT00351962

Phase I/II Study of Fractionated Stereotactic Radiotherapy for Medically Inoperable NSCLC or Metastatic Lung Tumors

Age: 18 and over

Sponsor: Other

STUDY LEAD ORGANIZATION

Alberta Cancer Board

Harold Lau, MD, Principal Investigator; Ph: 403-521-3842

M05-782, NCT00354562

ABT-751 in Combination With Docetaxel in Treating Patients With Advanced or Metastatic Non-Small-Cell Lung Cancer

Age: 18 and over

Sponsor: Pharmaceutical/Industry

STUDY LEAD ORGANIZATION

Abbott Laboratories

Global Medical Information, Abbott; Ph: 800-633-9110

310101, NCT00359359, EudraCT No: 2006-000067-29

Safety, Tolerability, Efficacy, and Pharmacokinetics Study of a New Chemotherapy Agent in Combination with Cisplatin to Treat Small-Cell Lung Cancer

Age: 18 and over

Sponsor: Pharmaceutical/Industry

STUDY LEAD ORGANIZATION

Schering Aktiengesellschaft

Schering AG, Germany, Medical Affairs; Ph: 49-30-46811800

UARIZ-HSC-0353, NCT00363805, U01-CA-101204

Phase II Randomized Study of Green Tea or Polyphenon E in Preventing Lung Cancer in Former Smokers With Chronic Obstructive Pulmonary Disease

Age: 40 to 80

Sponsor: NCI

STUDY LEAD ORGANIZATION

Arizona Cancer Center at University of Arizona Health Sciences Center

Iman Hakim, MD, PhD, MPH, Principal Investigator; Ph: 520-626-5355, 800-622-2673; Email: ihakim@azcc.arizona.edu

UMN-2005LS083, UMN-0602M81427, NCT00365547

Phase II Study of Topotecan Hydrochloride and Bevacizumab in Patients With Stage IIIB or IV Non-Small-Cell Lung Cancer Who Have Failed Prior Systemic Chemotherapy

Age: 18 and over

Sponsor: NCI

STUDY LEAD ORGANIZATION

University of Minnesota Cancer Center

Arkadiusz Dudek, MD, Protocol chair; Ph: 612-624-6610; Email: dudek002@umn.edu

TREAT, NCT00349089, EudraCT Number 2005-004840-30

Trial on Refinement of Early-Stage Lung Cancer Adjuvant Therapy

Age: 18 to 74

Sponsor: Other

STUDY LEAD ORGANIZATION

Thoraxklinik Heidelberg

Dr. Michael Thomas, Principal Investigator; Ph: 49-6221-396, ext.1300; Email: michael.thomas@thoraxklinik-heidelberg.de

Dr. Michael Kreuter, Study chair; Ph: 49-6221-396, ext. 0; Email: michael.kreuter@thoraxklinik-heidelberg.de

© 2006 Lippincott Williams & Wilkins, Inc.
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