Status:
COMPLETED
Study of Immune Response Modifier in the Treatment of Breast, Ovarian, Endometrial and Cervical Cancers
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Collaborating Sponsors:
Pfizer
Conditions:
Breast Cancer
Ovarian Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 Criteria
Inclusion
- 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
- 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
- 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
- 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
- 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
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00319748
Start Date
April 1 2006
End Date
December 1 2008
Last Update
August 26 2019
Active Locations (1)
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1
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455