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

NCT01516307 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: OPT-822-001
• Study Type: interventional
• Target: 349
• Locations: 5 countries
• Sites: 43

Brief Summary

The purpose of this study is to compare active immunotherapy (OPT-822/OPT-821) with PBS in combination with low dose cyclophosphamide, in post-treated metastatic breast cancer subjects with stable disease or response to treatment.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  Progression or up to 2 years

Secondary Outcomes (1)

• Overall Survival (OS)

  5 years

Study Arms (2)

OPT-822/OPT-821 (30 μg/100 μg) and Cyclophosphamide

EXPERIMENTAL

Patients will be randomized 2:1 to receive OPT-822/OPT-821(30 μg/100 μg) plus Cyclophosphamide IV (300mg/m2).

Biological: OPT-822/OPT-821(30 μg/100 μg); Drug: Cyclophosphamide

Phosphate Buffer Saline (PBS) and Cyclophosphamide

PLACEBO COMPARATOR

Patients will receive Phosphate Buffer Saline (PBS) plus Cyclophosphamide IV (300mg/m2).

Biological: Phosphate Buffer Saline (PBS); Drug: Cyclophosphamide

Interventions

OPT-822/OPT-821(30 μg/100 μg) BIOLOGICAL

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

OPT-822/OPT-821 (30 μg/100 μg) and Cyclophosphamide

Phosphate Buffer Saline (PBS) BIOLOGICAL

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

Phosphate Buffer Saline (PBS) and Cyclophosphamide

Cyclophosphamide DRUG

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

OPT-822/OPT-821 (30 μg/100 μg) and Cyclophosphamide; Phosphate Buffer Saline (PBS) and Cyclophosphamide

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female subjects ≥ 21 years of age with histological or cytological diagnosis of breast carcinoma.
• Subjects with metastatic breast cancer who have achieved stable disease (SD), partial response (PR), or complete response (CR) after at least 1 regimen of anticancer therapy (i.e. chemotherapy or target therapy, either alone or in any combination). Involvement of supraclavicular lymph node is considered metastasis.
• Subjects must have recovered from toxicities of prior therapies. (i.e. CTCAE ≤ grade 2).
• Performance status: ECOG ≤ 1 and life expectancy ≥ 3 months.
• Organ Function Requirements - Subjects must have adequate organ functions as defined below:
• AST/ALT ≤ 3X ULN (upper limit of normal)
• AST/ALT ≤ 5X ULN \[with underlying Liver Metastasis\]
• Total Bilirubin ≤ 2.0 X ULN
• Serum Creatinine ≤ 1.5X ULN
• ANC ≥ 1500 /μL
• Platelets \> 100,000/μL
• No Symptomatic Congestive Heart Failure (Ejection Fraction EF ≥ 50%)
• Ability to understand and the willingness to sign a written informed consent document according to institutional guidelines.
• All positive or negative ER (estrogen receptor), PR (progesterone receptor), and HER-2 subjects are eligible for this study.
• However, subjects who are HER-2 positive and responsive to anti-HER-2 therapy (e.g. Herceptin), are encouraged to remain on anti-HER-2 therapy and not enroll in this trial.

You may not qualify if:

• Subjects are pregnant or breast-feeding at entry.
• Subjects with more than 2 events of disease progression after the development of metastatic breast cancer.
• Subjects who are currently receiving any other concomitant anticancer therapy with the EXCEPTION of bisphosphonates and hormone therapy.
• During the study period, subjects using hormonal therapy and bisphosphonates should maintain a constant dose and should not change existing regimen.
• However, if a change in hormonal therapy is indicated, e.g. due to intolerable adverse effects, the regimen may be modified but change should be minimized thereafter.
• Subjects with metastasis limited to the bone only are excluded. However, subjects with current metastasis limited to the bone only and with a history of distant metastasis are eligible. Subjects with current metastasis limited to the bone only and with current breast tissue lesion are eligible.
• Subjects who have any history of other malignancy (except non-melanoma skin carcinoma and carcinoma-in-situ of the uterine cervix) within 5 years of study entry.
• Subjects with splenectomy.
• Subjects with HIV infection.
• Subjects with any major autoimmune diseases or autoimmune disorders requiring systemic iv/oral steroids or immunosuppressive or immunomodulatory therapies.
• e.g. Type 1 juvenile onset diabetes mellitus, antibody positive for rheumatoid arthritis, Grave's disease, Hashimoto's thyroiditis, lupus, scleroderma, systemic vasculitis, hemolytic anemia, immune mediated thrombocytopenia, etc
• Autoimmune disorders confined to the skin (e.g. psoriasis) are eligible, and topical steroids are allowed for the treatment of such skin disorders.
• Subjects with any known uncontrolled inter-current illness including ongoing or active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Subjects with any of the following MEDICATIONS within 4 weeks prior to randomization:
• Anti-neoplastic agents

Sponsors & Collaborators

• OBI Pharma, Inc: lead

Study Sites (43)

The University of Alabama at Birmingham (UAB)

Birmingham, Alabama, 35294, United States

Location

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

Fullerton, California, 92835, United States

Location

University of California, San Diego (UCSD)

La Jolla, California, 92093, United States

Location

University of California, Irvine (UCI)

Orange, California, 92868, United States

Location

University of California, San Francisco (UCSF)

San Francisco, California, 94115, United States

Location

Coastal Integrative Cancer Care

San Luis Obispo, California, 93401, United States

Location

Central Coast Medical Oncology Corporation

Santa Maria, California, 93454, United States

Location

University of California, Los Angeles (UCLA)

Santa Monica, California, 90404, United States

Location

Memorial Regional Hospital

Hollywood, Florida, 33021, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Hope Women's Cancer Center

Asheville, North Carolina, 28801, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

UNIMED Medical Institute

Hong Kong, China

Location

HCG, Bangalore Institute of Oncology

Bengaluru, India

Location

Curie Manavata Cancer Centre

Mumbai, India

Location

Dong-A University Hospital

Busan, South Korea

Location

Pusan National University Hospital

Busan, South Korea

Location

Inha University Hospital

Chungcheongbuk-Do, South Korea

Location

National Cancer Center

Chungcheongbuk-Do, South Korea

Location

Kyungpook National University Medical Center

Daegu, South Korea

Location

Yeungnam University Medical Center

Daegu, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

Seoul National University Hospital ,

Seoul, South Korea

Location

Seoul St. Mary's Hospital

Seoul, South Korea

Location

Severance Hospital

Seoul, South Korea

Location

Changhua Christian Hospital

Changhua, Taiwan

Location

Chang Gung Memorial Hospital-KS

Kaohsiung City, Taiwan

Location

Kaohsiung Medical University Hospital

Kaohsiung City, Taiwan

Location

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

Location

Chang Gung Memorial Hospital -Linkou

Linkou District, Taiwan

Location

Mackay Memorial Hospital

New Taipei City, Taiwan

Location

China Medical University Hospital

Taichung, Taiwan

Location

Taichung Veterans General Hospital

Taichung, Taiwan

Location

Chi Mei Medical Center

Tainan, Taiwan

Location

National Cheng Kung University Hospital

Tainan, Taiwan

Location

Chang Gung Memorial Hospital-Taipei

Taipei, Taiwan

Location

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Shuang-Ho Hospital

Taipei, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

Tri-Service General Hospital

Taipei, Taiwan

Location

Related Publications (1)

• Huang CS, Yu AL, Tseng LM, Chow LWC, Hou MF, Hurvitz SA, Schwab RB, L Murray J, Chang HK, Chang HT, Chen SC, Kim SB, Hung JT, Ueng SH, Lee SH, Chen CC, Rugo HS. Globo H-KLH vaccine adagloxad simolenin (OBI-822)/OBI-821 in patients with metastatic breast cancer: phase II randomized, placebo-controlled study. J Immunother Cancer. 2020 Jul;8(2):e000342. doi: 10.1136/jitc-2019-000342.

  PMID: 32718986 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2012
• First Posted: January 24, 2012
• Study Start: December 1, 2011
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2019
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (11); CN (1); TW (16); US (13); IN (2)