Patient case: 45-year-old female with cervical cancer; genetic feature: ERBB2 (S310Y)

Clinical trial: Study of Immune Response Modifier in the Treatment of Breast, Ovarian, Endometrial and Cervical Cancers

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.

Detailed description: 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: 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

Relevance to patient case: possibly relevant