PRESENT: Efficacy and Safety Study of NeuVax™ (Nelipepimut-S or E75) Vaccine to Prevent Breast Cancer Recurrence
Sponsor
Galena Biopharma, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01479244
Collaborator
(none)
758
197
2
58.7
3.8
0.1
Study Details
Study Description
Brief Summary
Purpose of this trial:
-
To assess the efficacy and safety of NeuVax™ administered with adjuvant Leukine® (sargramostim, GM-CSF).
-
To evaluate and compare the disease free survival (DFS) in the vaccinated and control subjects.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
This is a multicenter, multinational, prospective, randomized, double-blind, controlled Phase 3 study.
The subjects eligible for this trial have an early stage node-positive breast cancer. Their tumors express low or intermediate levels of the HER2 protein. NeuVax™ will be administered after completion of front-line, standard of care therapy (surgery, radiation therapy, and chemotherapy) and can be given concomitantly with physician prescribed endocrine treatment.
NeuVax™ is the immmunodominant nonapeptide derived from the extracellular domain of the HER2 protein, a well-established target for therapeutic intervention in breast carcinoma. The nelipepimut sequence stimulates specific CD8+ cytotoxic T lymphocytes (CTL) following binding to HLA-A2/A3 molecules on antigen presenting cells (APC). These activated specific CTLs recognize, neutralize and destroy through cell lysis HER2 expressing cancer cells, including occult cancer cells and micrometastatic foci. The nelipepimut immune response can also generate CTLs to other immunogenic peptides through inter- and intra-antigenic epitope spreading. Based on a successful Phase 2 trial, which achieved its primary endpoint of DFS, the Food and Drug Administration (FDA) granted NeuVax a Special Protocol Assessment (SPA) for its Phase 3 PRESENT (Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer with Low to Intermediate HER2 Expression with NeuVax Treatment) study.
The active portion of the study will last three years (36 months). The follow-up will last from 5 to 10 years.
Endpoints:
- Primary efficacy endpoint:
- 3-year DFS
- Secondary efficacy endpoints:
-
5- and 10-year DFS
-
3-year OS
-
5- and 10-year OS
-
Safety profile, and adverse events (AEs)
-
Patterns of recurrence to include Time to recurrence (TTR), time to local recurrence (TTLR), time to distant recurrence (TTDR), time to bone metastases (TTBM)
Safety Assessments:
Subjects will be assessed at every study visit for the safety endpoints, AEs,vital signs, physical examinations and laboratory data; yearly follow-up of survival will include imaging studies, ECGs, MUGA or ECHO scans and concomitant medications.
Study Design
Study Type:
Interventional
Actual Enrollment
:
758 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
PRESENT: Prevention of Recurrence in Early-Stage, Node-Positive Breast Cancer With Low to Intermediate HER2 Expressions With NeuVax™Treatment
Study Start Date
:
Nov 1, 2011
Actual Primary Completion Date
:
Sep 21, 2016
Actual Study Completion Date
:
Sep 21, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: NeuVax™ NeuVax™ in WFI solution with Leukine® |
Biological: NeuVax™ vaccine
E75 peptide acetate (HER2/neu p366-379) in WFI (1.5 mg/mL) mixed with 250 micrograms Leukine® (sargramostim, GM-CSF), will be administered in intradermal injections, in four divided doses (4 sites on upper thigh) once a month, for six consecutive months. At the end of the six months, NeuVax™ vaccine boosters will be given the same way once every six months for the next five times (totaling 36 months).
Other Names:
|
| Active Comparator: Leukine® Leukine® with WFI |
Biological: Leukine® (sargramostim, GM-CSF) and water for injection
Leukine® 250 micrograms in water for injection, will be administered in intradermal injections, in four divided doses (4 sites on upper thigh) once a month, for six consecutive months. At the end of the six months, boosters inoculations will be given the same way once every six months for the next five times (totaling 36 months).
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Comparison of DFS in vaccine treated patients and control patients [36 months]
The primary objective is to compare the DFS in subjects with operable early-stage, node-positive breast cancer who receive standard of care multimodality therapy plus NeuVax™ as the treatment group or standard of care multimodality therapy plus the vaccine adjuvant, Leukine® as the control group.
Secondary Outcome Measures
- Assessment of DFS and OS at 3, 5 and 10 years in vaccine and control groups, respectively; assessment of safety [3 through 10 years]
The secondary objectives are to evaluate the 2 groups of subjects for: 5- and 10-year DFS 3-year OS 5- and 10-year OS Time to recurrence (TTR), time to local recurrence (TTLR), time to distant recurrence (TTDR), time to bone metastases (TTBM) Overall safety profile and adverse events (AEs)
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Key Inclusion Criteria:
-
Pathological diagnosis of invasive adenocarcinoma of the breast
-
Breast cancer completely excised, or patient receiving neoadjuvant therapy prior to surgery
-
One of these 2 surgical treatments and axillary staging with sentinel lymph node dissection or axillary dissection level I/II:
-
Total mastectomy-patients with a positive sentinel lymph node must have undergone a completion axillary dissection level I/II
-
BCS (lumpectomy)-patients with a positive sentinel lymph node must have undergone a completion axillary dissection level I/II unless they had clinically node negative T1-T2 tumors and fewer than 3 involved lymph nodes
-
Node-positive disease
-
Primary tumor stage T1-3 at initial diagnosis
-
HER2 negative (HER2 1+ by IHC or HER2 2+ by IHC/FISH)
-
HLA-A2 or HLA-A3 haplotype
-
Completed NCCN approved neo-adjuvant/adjuvant chemotherapy or both
-
Completed radiation therapy
-
No evidence of disease
-
Able and willing (or have legal representative) to understand the study and provide consent
Key Exclusion Criteria:
-
Bilateral breast malignancy or suspicious mass in opposite breast
-
Inflammatory breast malignancy
-
History of prior breast cancer, ductal carcinoma in situ
-
Prior trastuzumab therapy
-
New York Heart Association Stage 3 or 4 cardiac disease
-
Sensory/motor neuropathy ≥ Grade 2
-
Autoimmune diseases or immune deficiency disease
-
Subjects on chronic steroid therapy, other immunosuppressive therapy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alabama Oncology | Bessemer | Alabama | United States | 35022 |
| 2 | Physicians Pain Specialists of Alabama, P.C. | Mobile | Alabama | United States | 36606 |
| 3 | Pain Centers Nationwide | Peoria | Arizona | United States | 83582 |
| 4 | Valley Pain Consultants | Scottsdale | Arizona | United States | 85254 |
| 5 | East Valley Hematology and Oncology Medical Group | Burbank | California | United States | 91505 |
| 6 | Coastal Pain Research | Carlsbad | California | United States | 92009 |
| 7 | Navajo Road Pain Management Center | El Cajon | California | United States | 92020 |
| 8 | California Cancer Associates for Research and Excellence, Inc. | Fresno | California | United States | 93720 |
| 9 | California Cancer Associates For Research and Excellence | Fresno | California | United States | 93720 |
| 10 | St. Jude Medical Center, Virginia K. Crosson Cancer Center | Fullerton | California | United States | 92801 |
| 11 | Interventional Pain Management | Irvine | California | United States | 92618 |
| 12 | South Orange County Surgical Medical Group | Laguna Hills | California | United States | 92653 |
| 13 | University of Southern California/Norris Cancer Hospital | Los Angeles | California | United States | 90033 |
| 14 | Alexander Ford, MD | Los Angeles | California | United States | 90035 |
| 15 | Cancer Care Institute | Los Angeles | California | United States | 90036 |
| 16 | Pete J. Ruane, MD, Inc. | Los Angeles | California | United States | 90036 |
| 17 | Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute | Los Angeles | California | United States | 90048 |
| 18 | Moores UC San Diego Cancer Center (UCSD) | San Diego | California | United States | 92093 |
| 19 | University of California, San Francisco (UCSF), Hellen Diller Family Comprehensive Cancer Center | San Francisco | California | United States | 94115 |
| 20 | Pain Institute of Santa Monica | Santa Monica | California | United States | 90404 |
| 21 | Randy Scharlach, MD | Woodland Hills | California | United States | 91367 |
| 22 | University of Colorado Cancer Center, Anschutz Medical Campus | Aurora | Colorado | United States | 80045 |
| 23 | Red Rocks Center for Rehabilitation | Golden | Colorado | United States | 80401 |
| 24 | Western Connecticut Health Network, Danbury Hospital | Danbury | Connecticut | United States | 06810 |
| 25 | Stamford Hospital, Bennett Cancer Center | Stamford | Connecticut | United States | 06904 |
| 26 | Pain Management Associates of CT, PC | Stamford | Connecticut | United States | 06905 |
| 27 | Innovative Medical Research of South Florida, Inc. | Aventura | Florida | United States | 33180 |
| 28 | Holy Cross Hospital-Michael & Dianne Bienes Comprehensive Cancer Center | Fort Lauderdale | Florida | United States | 33308 |
| 29 | Cancer Specialists of North Florida (ICON) | Jacksonville | Florida | United States | 32256 |
| 30 | MD Anderson Center-Orlando Health | Orlando | Florida | United States | 32806 |
| 31 | Florida Cancer Research Institute (Florida Cancer Care) | Plantation | Florida | United States | 33317 |
| 32 | Florida Cancer Care | Plantation | Florida | United States | 33324 |
| 33 | H.Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | United States | 33612 |
| 34 | Northeast Georgia Cancer Care | Athens | Georgia | United States | 30607 |
| 35 | Interventional Spine and Pain Management | Atlanta | Georgia | United States | 30309 |
| 36 | Central Georgia Cancer Care | Macon | Georgia | United States | 31201 |
| 37 | Cancer Treatment Centers of America | Newnan | Georgia | United States | 30265 |
| 38 | Northwestern University Feinberg School of Medicine, Lynn Sage Comprehensive Breast Center | Chicago | Illinois | United States | 60611 |
| 39 | Pain Management Institute | Overland Park | Kansas | United States | 66210 |
| 40 | Cancer Center of Kansas | Wichita | Kansas | United States | 67214 |
| 41 | James Graham Brown Cancer Center, University of Louisville | Louisville | Kentucky | United States | 40202 |
| 42 | Mary Bird Perkins Cancer Center | Baton Rouge | Louisiana | United States | 70809 |
| 43 | Center of Cancer and Blood Disorders (VEEDA network) | Bethesda | Maryland | United States | 20817 |
| 44 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02215 |
| 45 | Lahey Clinic Department of Hematology and Oncology | Burlington | Massachusetts | United States | 01805 |
| 46 | Physiatry Consultants | Bay City | Michigan | United States | 48796 |
| 47 | Michigan Interventional Pain Center | Brownstown | Michigan | United States | 48183 |
| 48 | William Beaumont Hospital Cancer Center | Royal Oak | Michigan | United States | 48071 |
| 49 | Glenn Saperstein, D.O., LLC | Saginaw | Michigan | United States | 48604 |
| 50 | Advanced Physical Medicine | St. Clair Shores | Michigan | United States | 48080 |
| 51 | Eastchester Cancer Care Center | Bronx | New York | United States | 10469 |
| 52 | Fountain Medical Group | New York | New York | United States | 10021 |
| 53 | Weill Cornell Medical College | New York | New York | United States | 100665 |
| 54 | Upper East Side Pain Medicine, P.C. | New York | New York | United States | 36607 |
| 55 | Comprehensive Pain Management | Syosset | New York | United States | 11791 |
| 56 | APWI | Williamsville | New York | United States | 14221 |
| 57 | Wake Forest Baptist Health | Winston-Salem | North Carolina | United States | 27157 |
| 58 | St. Alexius Medical Center, Mid Dakota Clinic, PC | Bismarck | North Dakota | United States | 58501 |
| 59 | Akron General Medical Center | Akron | Ohio | United States | 44302 |
| 60 | Cancer Treatment Centers of America | Tulsa | Oklahoma | United States | 74133 |
| 61 | OHSU Knight Cancer Institute | Portland | Oregon | United States | 97239 |
| 62 | Gettysburg Cancer Center | Gettysburgh | Pennsylvania | United States | 17325 |
| 63 | Conemaugh Memorial Hospital-Memorial Medical Center | Johnstown | Pennsylvania | United States | 15905 |
| 64 | J. Fred Stoner, MD | New Castle | Pennsylvania | United States | 16101 |
| 65 | University of Pittsburgh Medical Center (UPMC) Cancer Center | Pittsburgh | Pennsylvania | United States | 15232 |
| 66 | Progressive Pain Solutions | Wind Gap | Pennsylvania | United States | 18091 |
| 67 | Jerrold Rosenberg, MD | Providence | Rhode Island | United States | 02904 |
| 68 | The West Clinic Comprehensive Breast Center | Germantown | Tennessee | United States | 38138 |
| 69 | The West Clinic | Memphis | Tennessee | United States | 38120 |
| 70 | PRIDE | Dallas | Texas | United States | 75235 |
| 71 | UT Southwestern Medical Center / Simmons Comprehensive Cancer Center | Dallas | Texas | United States | 75390 |
| 72 | Brooke Army Medical Center (now SAMMC) | Ft. Sam Houston | Texas | United States | 78234 |
| 73 | Baylor College of Medicine | Houston | Texas | United States | 77030 |
| 74 | The University of Texas MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
| 75 | University of Texas MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
| 76 | Cancer Care Centers of South Texas | San Antonio | Texas | United States | 78229 |
| 77 | Clinical Trials of Texas, Inc | San Antonio | Texas | United States | 78229 |
| 78 | Virginia Cancer Specialists | Fairfax | Virginia | United States | 22031 |
| 79 | Swedish Cancer Institute Research | Seattle | Washington | United States | 98104 |
| 80 | Multicare Health System-Research Institute | Tacoma | Washington | United States | 98405 |
| 81 | Medical College of Wisconsin Department of Surgery Froedtert Hospital and Cancer Center | Milwaukee | Wisconsin | United States | 52336 |
| 82 | Central Onco Hospital | Plovdiv | Bulgaria | 4002 | |
| 83 | Serdika | Sofia | Bulgaria | 1303 | |
| 84 | Tsaritsa Yoanna - ISUL | Sofia | Bulgaria | 1527 | |
| 85 | Complex Oncology Center, Veliko Tarnovo | Tarnovo | Bulgaria | 5000 | |
| 86 | Sveta Marina | Varna | Bulgaria | 9010 | |
| 87 | Cross Cancer Institute | Edmonton | Alberta | Canada | T6G1Z2 |
| 88 | Ottawa Hospital Cancer Centre | Ottawa | Ontario | Canada | K1H 8L6 |
| 89 | Health Sciences North Cancer Centre | Sudbury | Ontario | Canada | P3E 5J1 |
| 90 | Sunnybrook Research Institute | Toronto | Ontario | Canada | M4N 3M5 |
| 91 | Hospital Charles LeMorne | Greenfield Park | Quebec | Canada | J4V 2H1 |
| 92 | Masaryk Memorial Cancer Institute, Comprehensive Cancer Care Clinic | Brno | Czech Republic | 656 53 | |
| 93 | University Hospital Hradec Kralove, Clinic of Oncology and Radiotherapy | Hradec Kralove | Czech Republic | 500 05 | |
| 94 | University Hospital Olomouc, Clinic of Oncology | Olomouc | Czech Republic | 775 20 | |
| 95 | General University Hospital in Prague, Clinic of Oncology | Prague 2 | Czech Republic | 128 08 | |
| 96 | Institut de Cancérologie de l'Ouest Siet Paul Papin | Angers | Cedex 9 | France | 49933 |
| 97 | Centre Oscar Lambret | Cédex | Lille | France | 59020 |
| 98 | Institut de Cancérologie de l'Ouest/René Gauducheau | St Herblain, Nantes Cedex | Loire-Atlantique | France | 44805 |
| 99 | Centre Antoine Lacassagne | Nice | France | 06189 | |
| 100 | Charité Campus Mitte Universitaetsmedizin-Berlin Brustzentrum/Studienzentrum | Berlin | Germany | 10117 | |
| 101 | Brustzentrum Klinikum Bremen-Mitte gGmbH | Bremen | Germany | 28177 | |
| 102 | Universitätsklinikum Erlangen, Frauenklinik | Erlangen | Germany | D-91054 | |
| 103 | Kliniken Essen Mitte, Evang. Huyssens Stiftung/Knappschaft GmbH, Klinik für Senologie/Brustzentrum | Essen | Germany | D-45136 | |
| 104 | Universitätsklinikum Frankfurt, Klinik für Frauenheilkunde und Geburtshilfe | Frankfurt | Germany | 60590 | |
| 105 | Nationales Centrum für Tumorerkrankungen (NCT), Gynäkologische Onkologie | Heidelberg | Germany | 69120 | |
| 106 | Universitätsklinikum Schleswig-Holstein, Campus Kiel | Kiel | Germany | 24105 | |
| 107 | Universität Marburg | Marburg | Germany | 35043 | |
| 108 | Rotkreuzklinikum München gGmbH, Frauenklinik | Muenchen | Germany | 80637 | |
| 109 | Universitätsklinikum Münster, Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe | Münster | Germany | 48149 | |
| 110 | Klinikum Stuttgart, Krankenhaus Bad Cannstatt, Frauenklinik | Stuttgart | Germany | 70374 | |
| 111 | Klinikum Mutterhaus der Borromaeerinnen | Trier | Germany | 54290 | |
| 112 | Gemeinschaftspraxis für Innere Medizin, Haematologie und internistische Onkologie Dr. R Schlag/Dr. Schoettker | Wuerzburg | Germany | D-97080 | |
| 113 | Hetenyi Geza Hospital, Department of Oncology | Szolnok | Jasz-Nagykun-Szolnok | Hungary | H-5000 |
| 114 | Szent Margit Hospital, V. Department of Internal Medicine, Oncology | Budapest | Hungary | H-1032 | |
| 115 | Semmelweis University, Department of Diagnostic Radiology and Oncotherapy | Budapest | Hungary | H-1083 | |
| 116 | Petz Aladar County Teaching Hospital, Center for Oncoradiology | Gyor | Hungary | H-9024 | |
| 117 | Kaposi Mor County Teaching Hospital, Center for Clinical Oncology | Kaposvar | Hungary | 7400 | |
| 118 | Borsod-Abauj-Zemplen County Hospital and University Educational Hospital, Center for Clinical Oncology and Radiology | Miskolc | Hungary | 3526 | |
| 119 | Sheba Medical Centre | Tel Hasomer | Ramat Gan | Israel | 52621 |
| 120 | Rambam Health Care Campus | Haifa | Israel | 31096 | |
| 121 | Rabin Medical Centre | Petach Tikva | Israel | 49100 | |
| 122 | Kaplan Medical Centre | Rehovot | Israel | 76100 | |
| 123 | Provincial Specialist Hospital in Wroclaw, Department of Chemotherapy | Kamienskiego | Wroclaw | Poland | 51-124 |
| 124 | Polish Red Cross Marine Hospital, Department of Chemotherapy | Gdynia | Poland | 81-519 | |
| 125 | Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz, Department of Chemotheraphy | Lodz | Poland | 93-513 | |
| 126 | Greater Poland Cancer Center, Department of Chemotherapy | Poznan | Poland | 61-866 | |
| 127 | Magodent | Warsaw | Poland | 04-125 | |
| 128 | Non-Public Health Care Facility MAGODENT | Warsaw | Poland | 04-125 | |
| 129 | "Gavril Curteanu" Municipal Clinical Hospital | Oradea | Bihor | Romania | 410469 |
| 130 | Medisprof SRL, Department of Medical Oncology | Cluj-Napoca | Cluj | Romania | 400058 |
| 131 | Oncology Center "Sf. Nectarie", Department of Medical Oncology | Craiova | Dolj County | Romania | 200347 |
| 132 | Dr. Constantin Opris County Emergency Hospital, Department of Oncology | Baia Mare, Maramures | Romania | 430031 | |
| 133 | Filantropia Clinical Hospital, Obstetrics and Gynaecology Department | Bucharest | Romania | 011171 | |
| 134 | Coltea Clinical Hospital, Oncology Department | Bucharest | Romania | 030171 | |
| 135 | Bucharest Universtiy Emergency Hosptial, Oncology Department | Bucharest | Romania | 050098 | |
| 136 | "Prof. Dr. Ion Chiricuta" Institute of Oncology | Cluj-Napoca | Romania | 400015 | |
| 137 | Iasi Regional Oncology Institute, Department of Medical Oncology | Iasi | Romania | 700483 | |
| 138 | Oncomed SRL, Department of Medical Oncology | Timisoara | Romania | 300239 | |
| 139 | Oncology Center #2, Department of Healthcare of Krasnodar Territory Administration | Sochi | Krasnodar | Russian Federation | 354057 |
| 140 | Republican Oncology Center | Saransk | Republic of Mordovia | Russian Federation | 430032 |
| 141 | Republican Clinical Oncoogy Center | Kazan | Republic of Tatarstan | Russian Federation | 420029 |
| 142 | Pyatigorsk Oncology Center | Pyatigorsk | Stavropol Region | Russian Federation | 357502 |
| 143 | Arkhangelsk Clinical Oncology Center | Arkhangelsk | Russian Federation | 163045 | |
| 144 | Sverdlovsk Regional Oncology Center | Ekaterinburg | Russian Federation | 620036 | |
| 145 | Regional Oncology Center | Irkutsk | Russian Federation | 664035 | |
| 146 | Ivanovo Regional Oncology Center | Ivanovo | Russian Federation | 153040 | |
| 147 | Clinical Oncology Center #1, Department of Healthcare of Krasnodar Territory Administration | Krasnodar | Russian Federation | 350040 | |
| 148 | Krasnoyarsk Kryzhanovsky Regional Oncology Center | Krasnoyarsk | Russian Federation | 660133 | |
| 149 | Kursk Regional Clinical Oncology Center | Kursk | Russian Federation | 305035 | |
| 150 | N.N. Blokhin Russian Cancer Research Center | Moscow | Russian Federation | 115478 | |
| 151 | N.N. Blokhin Russian Cancer Reserach Center | Moscow | Russian Federation | 115478 | |
| 152 | Clinical Diagnostics Center | Nizhny Novgorod | Russian Federation | 603006 | |
| 153 | Nizhny Novgorod Regional Oncology Center | Nizhny Novgorod | Russian Federation | 603081 | |
| 154 | Orel Oncology Center | Orel | Russian Federation | 302020 | |
| 155 | Orenburg Regional Clinical Oncology Center | Orenburg | Russian Federation | 460051 | |
| 156 | Medical Institution of Ryazan Region | Ryazan | Russian Federation | 390011 | |
| 157 | Samara Regional Clinical Oncology Center | Samara | Russian Federation | 443031 | |
| 158 | Petrov Research Institute of Oncology | St Petersburg | Russian Federation | 197758 | |
| 159 | Leningrad Regional Oncology Center | St. Petersburg | Russian Federation | 191104 | |
| 160 | St. Petersburg Clinical Hospital | St. Petersburg | Russian Federation | 194017 | |
| 161 | Mechnikov North-Western State Medical University | St. Petersburg | Russian Federation | 195067 | |
| 162 | Municipal Clinical Oncology Center | St. Petersburg | Russian Federation | 198255 | |
| 163 | Tambov Regional Clinical Oncology Center | Tambov | Russian Federation | 392013 | |
| 164 | Research Institute of Oncology | Tomsk | Russian Federation | 634028 | |
| 165 | Bashkir State Medical University | Ufa | Russian Federation | 450000 | |
| 166 | Regional Clinical Oncology Center | Veliky Novgorod | Russian Federation | 173016 | |
| 167 | Volgograd Regional Oncology Center #3 | Volzhskiy | Russian Federation | 404130 | |
| 168 | Yaroslavl Regional Oncology Center | Yaroslavl | Russian Federation | 150054 | |
| 169 | Clinical Diagnostics Center | Simferopol | Autonomous Republic of Crimea | Ukraine | 95000 |
| 170 | Kryvyi Rih Oncology Center/Dnipropetrovsk Regional Council, Department of Chemotherapy | Kryvyi Rih | Dnipropetrovsk Region | Ukraine | 50000 |
| 171 | Mariupol City Interdistrict Oncology Center, Surgery Department #2 | Mariupol | Donetsk Region | Ukraine | 87500 |
| 172 | Kharkiv Regional Clinical Oncology Center, Day Care Unit | Kharkiv | Kyivskyi District | Ukraine | 61070 |
| 173 | Chernivtsi Regional Clinical Oncology Center, Day Care Unit | Chernivtsi | Ukraine | 58013 | |
| 174 | Dnipropetrovsk City Multispecialty Clinical Hospital #4/Dnipropetrovsk Regional Council, Department of Chemotherapy | Dnipropetrovsk | Ukraine | 49102 | |
| 175 | Donetsk City Oncology Center | Donetsk | Ukraine | 83087 | |
| 176 | Donetsk Regional Antitumor Center, Oncosurgery Department #2 | Donetsk | Ukraine | 83092 | |
| 177 | State Institution: S.P. Grigoriev Institute of Medical Radiology Under the Academy of Medical Sciences of Ukraine | Kharkiv | Ukraine | 61024 | |
| 178 | Public Institution: Kiev Regional Oncology Hospital within Kyiv Regional Council | Kiev | Ukraine | 04107 | |
| 179 | Kirovohrad Regional Oncology Center, Department of Mammology | Kirovohrad | Ukraine | 25011 | |
| 180 | Kyiv City Clinical Oncology Center, Department of Chemotherapy | Kyiv | Ukraine | 03115 | |
| 181 | Lviv State Regional Treatment and Diagnostics Oncology Center, Department of Chemotherapy | Lviv | Ukraine | 79031 | |
| 182 | Odesa Regional Clinical Hospital, Center for Mastology | Odesa | Ukraine | 65000 | |
| 183 | Zakarpattia Regional Clinical Oncology Center, Department of Chemotherapy | Uzhhorod | Ukraine | 88014 | |
| 184 | Vinnytsia Regional Clinical Oncology Center | Vinnytsia | Ukraine | 21029 | |
| 185 | Public Institution Zaporizhia Regional Clinical Oncology Center within Zaporizhia Regional Council | Zaporizhia | Ukraine | 69040 | |
| 186 | Macclesfield District General Hospital | Macclesfield | Cheshire | United Kingdom | SK10 3BL |
| 187 | The Christie NHS Foundation Trust | Withington | Manchester | United Kingdom | M20 4BX |
| 188 | The Royal Marsden NHS Foundation Trust | Sutton | Surrey | United Kingdom | SM2 5PT |
| 189 | Leeds Teaching Hospitals Trust, St. James University Hospital | Leeds | West Yorkshire | United Kingdom | LS9 7TF |
| 190 | Leicester Royal Infirmary | Leicester | United Kingdom | LE1 5WW | |
| 191 | The Royal Marsden NHS Foundation Trust | London | United Kingdom | SW3 6JJ | |
| 192 | James Cook University Hospital | Middlesborough | United Kingdom | TS4 3BW | |
| 193 | Academic Unit of Oncology, Nottingham University Hospital-City Campus | Nottingham | United Kingdom | NG7 2UH | |
| 194 | Plymouth Oncology Centre, Derriford Hospital | Plymouth | United Kingdom | PL6 8DH | |
| 195 | Weston Park Hospital | Sheffield | United Kingdom | S10 2SJ | |
| 196 | Southampton General Hospital | Southampton | United Kingdom | SO16 6YD | |
| 197 | University Hospital of North Staffordshire | Stoke on Trent | United Kingdom | ST4 6QG |
Sponsors and Collaborators
- Galena Biopharma, Inc.
Investigators
- Principal Investigator: Elizabeth A Mittendorf, MD,FACS, M.D. Anderson Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Amin A, Benavides LC, Holmes JP, Gates JD, Carmichael MG, Hueman MT, Mittendorf EA, Storrer CE, Jama YH, Craig D, Stojadinovic A, Ponniah S, Peoples GE. Assessment of immunologic response and recurrence patterns among patients with clinical recurrence after vaccination with a preventive HER2/neu peptide vaccine: from US Military Cancer Institute Clinical Trials Group Study I-01 and I-02. Cancer Immunol Immunother. 2008 Dec;57(12):1817-25. doi: 10.1007/s00262-008-0509-2. Epub 2008 Apr 8.
- Mittendorf EA, Clifton GT, Holmes JP, Clive KS, Patil R, Benavides LC, Gates JD, Sears AK, Stojadinovic A, Ponniah S, Peoples GE. Clinical trial results of the HER-2/neu (E75) vaccine to prevent breast cancer recurrence in high-risk patients: from US Military Cancer Institute Clinical Trials Group Study I-01 and I-02. Cancer. 2012 May 15;118(10):2594-602. doi: 10.1002/cncr.26574. Epub 2011 Oct 11.
Responsible Party:
Galena Biopharma, Inc.
ClinicalTrials.gov Identifier:
NCT01479244
Other Study ID Numbers:
- NeuVax™ PH3-01, BB-IND 009187
- 2011-005219-98
First Posted:
Nov 24, 2011
Last Update Posted:
Feb 27, 2017
Last Verified:
Feb 1, 2017
Keywords provided by Galena Biopharma, Inc.
Additional relevant MeSH terms: