study of immune response modifier in the treatment of breast, ovarian, endometrial and cervical cancers

Conditions: Breast Cancer; Ovarian Cancer; Endometrial Cancer; Cervical Cancer

Summary: the purpose of this study is to evaluate the anti-tumor activity of 852a when used to treat metastatic breast, ovarian, endometrial or cervical cancer not responding to standard treatment.

852a will be administered as a subcutaneous injection (sc) 2 times per week for 12 weeks (24 doses) with provisions for dose escalation or reduction based on tolerability.

Eligibility criteria:
inclusion criteria: * adequate performance status: * breast - karnofsky score \> 50; * ovarian, endometrial or cervical - gynecologic oncology group (gog) performance score ≤2 * if female and of childbearing potential, are willing to use adequate contraception (hormonal, barrier method, abstinence) prior to study entry and for the duration of study participation. * normal organ function within 14 days of study entry * diagnosis of one of the following malignancies: * metastatic breast cancer (br) * metastatic ovarian cancer (ov) * metastatic endometrial cancer (em) * metastatic cervical cancer (cx) breast cancer inclusion criteria: * measurable metastatic disease (\>1cm) in at least one site other than bone-only * progression on or failure to respond to at least one previous chemotherapy regimen for metastatic disease * progression on prior therapy with a hormonal agent if estrogen receptor or progesterone receptor positive, and/or with trastuzumab if her2-neu positive. if patient has progressed through hormone or trastuzumab therapy only, must have received one chemotherapy regimen. ovarian cancer inclusion criteria: * measurable metastatic disease as defined by response evaluation criteria in solid tumors (recist) * primary tumor must have been diagnosed histologically as either epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (not borderline or low malignant potential epithelial carcinoma). * subjects must have failed at least two previous chemotherapy regimens. paclitaxel must have been a component of one or both regimens and cisplatin or carboplatin must have been a component of one or both regimens. endometrial cancer inclusion criteria: * measurable metastatic disease * histologically proven recurrent or persistent endometrial cancer that is not amenable to curative treatment with surgery and/or radiation therapy and has failed 2 previous treatment regimens cervical cancer inclusion criteria: * measurable metastatic disease * histologically proven recurrent or persistent squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix that is not amenable to curative treatment with surgery and/or radiation therapy and has failed 2 previous treatment regimens. exclusion criteria: * had/have the following prior/concurrent therapy: * systemic corticosteroids (oral or injectable) within 7 days of first dose of 852a (topical or inhaled steroids are allowed) * investigational drugs/agents within 14 days of first dose of 852a * immunosuppressive therapy, including cytotoxic agents within 14 days of first dose of 852a (nitrosoureas within 30 days of first dose) * drugs known to induce qt interval prolongation and/or induce torsades de pointes unless best available drug required to treat life-threatening conditions * radiotherapy within 3 weeks of the first dose of 852a * hematopoietic cell transplantation within 4 weeks of first dose of 852a * evidence of active infection within 3 days of first dose of 852a * active fungal infection or pulmonary infiltrates (prior treated disease stable for 2 weeks is allowable) * cardiac ischemia, cardiac arrhythmias or congestive heart failure uncontrolled by medication * history of, or clinical evidence of, a condition which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk * uncontrolled intercurrent or chronic illness * active autoimmune disease requiring immunosuppressive therapy within 30 days * active coagulation disorder not controlled with medication * pregnant or lactating * concurrent malignancy (if in remission, at least 5 years disease free) except for localized (in-situ) disease, basal carcinomas and cutaneous squamous cell carcinomas that have been adequately treated * any history of brain metastases or any other active central nervous system (cns) disease

Keywords: breast ovarian endometrial cervical metastatic 852a irm oncology metastatic cervical cancer metastatic ovarian cancer metastatic breast cancer metastatic endometrial cancer