A Double-blind, Randomized Trial of Active Immunotherapy With Globo H-KLH (OPT-822) in Subjects With Metastatic Breast Cancer
- Female subjects ≥ 21 years of age with histological or cytological diagnosis of
- 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
- Performance status: ECOG ≤ 1 and life expectancy ≥ 3 months.
- Organ Function Requirements - Subjects must have adequate organ functions as defined
- 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
- 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
- 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
- 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.