trial of active immunotherapy with globo h-klh (opt-822) in metastatic breast cancer subjects

Conditions: Metastatic Breast Cancer

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.


Eligibility criteria:
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.