Study of Immune Response Modifier in the Treatment of Breast, Ovarian, Endometrial and Cervical Cancers
Condition: Breast Cancer; Ovarian Cancer; Endometrial Cancer; Cervical Cancer
MeSH terms: Ovarian Neoplasms; Uterine Cervical Neoplasms; Endometrial Neoplasms
Intervention: 852A
Intervention description: 0.2% 852a subcutaneous injection, 2 times per week for 12 weeks (24 doses) starting at 0.6 mg/m2; subsequent dose escalation for additional courses may be increased by 0.2 mg/m2 not to exceed 1.2 mg/m2.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast; Ovarian; Endometrial; Cervical; Metastatic; 852A; IRM; Oncology; Metastatic Cervical Cancer; Metastatic Ovarian Cancer; Metastatic Breast Cancer; Metastatic Endometrial 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.
    

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