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

Metastatic Breast Cancer Clinical Trial

Official title:

A Double-blind, Randomized Trial of Active Immunotherapy With Globo H-KLH (OPT-822) in Subjects With Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01516307
• Other study ID #: OPT-822-001
• Status: Completed
• Phase: Phase 2
• Start date: December 2011
• Est. completion date: August 2019

Study information

• Verified date: September 2020
• Source: OBI Pharma, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 349
• Est. completion date: August 2019
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• 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.

• Subjects who desire to enroll in this study and for whom anti-HER-2 therapy is not available or contraindicated, may be eligible to enroll in this trial.

• In countries where continuous anti-HER2 therapy is considered standard of care for HER-2 positive metastatic disease, HER-2 positive subjects are not eligible.

• Women of childbearing potential must be willing to implement adequate contraception during the study. An adequate method of contraception will be at the investigator's discretion.

Exclusion Criteria:

• 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

• Immunotherapy [mAbs, Interferons, Cytokines (except GCSF)]

• Immunosuppressants (e.g. Cyclosporin, Rapamycin, Tacrolimus, Rituximab, Alemtuzumab, Natalizumab, etc.).

• Another investigational drug

• Subjects with pleural effusions and/or ascites, due to malignancy, requiring paracentesis every 2 weeks or more frequently.

• Subjects with any known severe allergies (e.g. anaphylaxis) to any active or inactive ingredients in the study drugs.

• Subjects with bladder inflammation and urinary outflow obstruction.

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	UNIMED Medical Institute	Hong-Kong
India	HCG, Bangalore Institute of Oncology	Bengaluru
India	Curie Manavata Cancer Centre	Mumbai
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Pusan National University Hospital	Busan-si
Korea, Republic of	Inha University Hospital	Chungcheongbuk-Do
Korea, Republic of	National Cancer Center	Chungcheongbuk-Do
Korea, Republic of	Kyungpook National University Medical Center	Daegu
Korea, Republic of	Yeungnam University Medical Center	Daegu
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Seoul National University Hospital ,	Seoul
Korea, Republic of	Seoul St. Mary's Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Taiwan	Changhua Christian Hospital	Changhua
Taiwan	Chang Gung Memorial Hospital-KS	Kaohsiung
Taiwan	Kaohsiung Medical University Hospital	Kaohsiung City
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung City
Taiwan	Chang Gung Memorial Hospital -Linkou	Linkou
Taiwan	Mackay Memorial Hospital	New Taipei City
Taiwan	China Medical University Hospital	Taichung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	Chi Mei Medical Center	Tainan City
Taiwan	Chang Gung Memorial Hospital-Taipei	Taipei
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Shuang-Ho Hospital	Taipei
Taiwan	Tri-Service General Hospital	Taipei
Taiwan	Koo Foundation Sun Yat-Sen Cancer Center	Taipei City
Taiwan	Taipei Veterans General Hospital	Taipei City
United States	Hope Women's Cancer Center	Asheville	North Carolina
United States	The University of Alabama at Birmingham (UAB)	Birmingham	Alabama
United States	University of Chicago Medical Center	Chicago	Illinois
United States	St. Jude Heritage Healthcare, Virginia K. Crosson Cancer Center	Fullerton	California
United States	Memorial Regional Hospital	Hollywood	Florida
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	University of California, San Diego (UCSD)	La Jolla	California
United States	Weill Cornell Medical College	New York	New York
United States	University of California, Irvine (UCI)	Orange	California
United States	University of California, San Francisco (UCSF)	San Francisco	California
United States	Coastal Integrative Cancer Care	San Luis Obispo	California
United States	Central Coast Medical Oncology Corporation	Santa Maria	California
United States	University of California, Los Angeles (UCLA)	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
OBI Pharma, Inc

Countries where clinical trial is conducted

United States,  China,  India,  Korea, Republic of,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS)		Progression or up to 2 years
Secondary	Overall Survival (OS)		5 years