Trial of Active Immunotherapy With Globo H-KLH (OPT-822) in Metastatic Breast Cancer Subjects

PHASE2CompletedINTERVENTIONAL
Enrollment

349

Participants

Timeline

Start Date

December 31, 2011

Primary Completion Date

August 31, 2016

Study Completion Date

August 31, 2019

Conditions
Metastatic Breast Cancer
Interventions
BIOLOGICAL

OPT-822/OPT-821(30 μg/100 μg)

Subcutaneously on week 1, 2, 3, 5, 9, 13, 17, 25, and 37. OPT-822 and OPT-821 are combined at time of injection.

BIOLOGICAL

Phosphate Buffer Saline (PBS)

Subcutaneously on week 1, 2, 3, 5, 9, 13, 17, 25, and 37.

DRUG

Cyclophosphamide

Subcutaneously on week 1, 2, 3, 5, 9, 13, 17, 25, and 37.

Trial Locations (43)

10065

Weill Cornell Medical College, New York

28801

Hope Women's Cancer Center, Asheville

33021

Memorial Regional Hospital, Hollywood

35294

The University of Alabama at Birmingham (UAB), Birmingham

60637

University of Chicago Medical Center, Chicago

77030

University of Texas MD Anderson Cancer Center, Houston

90404

University of California, Los Angeles (UCLA), Santa Monica

92093

University of California, San Diego (UCSD), La Jolla

92835

St. Jude Heritage Healthcare, Virginia K. Crosson Cancer Center, Fullerton

92868

University of California, Irvine (UCI), Orange

93401

Coastal Integrative Cancer Care, San Luis Obispo

93454

Central Coast Medical Oncology Corporation, Santa Maria

94115

University of California, San Francisco (UCSF), San Francisco

Unknown

UNIMED Medical Institute, Hong Kong

HCG, Bangalore Institute of Oncology, Bengaluru

Curie Manavata Cancer Centre, Mumbai

Dong-A University Hospital, Busan

Pusan National University Hospital, Busan

Inha University Hospital, Chungcheongbuk-Do

National Cancer Center, Chungcheongbuk-Do

Kyungpook National University Medical Center, Daegu

Yeungnam University Medical Center, Daegu

Asan Medical Center, Seoul

Korea University Anam Hospital, Seoul

Seoul National University Hospital ,, Seoul

Seoul St. Mary's Hospital, Seoul

Severance Hospital, Seoul

Changhua Christian Hospital, Changhua

Chang Gung Memorial Hospital-KS, Kaohsiung City

Kaohsiung Medical University Hospital, Kaohsiung City

Kaohsiung Veterans General Hospital, Kaohsiung City

Chang Gung Memorial Hospital -Linkou, Linkou District

Mackay Memorial Hospital, New Taipei City

China Medical University Hospital, Taichung

Taichung Veterans General Hospital, Taichung

Chi Mei Medical Center, Tainan City

National Cheng Kung University Hospital, Tainan City

Chang Gung Memorial Hospital-Taipei, Taipei

Koo Foundation Sun Yat-Sen Cancer Center, Taipei

National Taiwan University Hospital, Taipei

Shuang-Ho Hospital, Taipei

Taipei Veterans General Hospital, Taipei

Tri-Service General Hospital, Taipei

Sponsors

Lead Sponsor

All Listed Sponsors
lead

OBI Pharma, Inc

INDUSTRY