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

University of Minnesota (UMN)

Status and phase: Completed; Phase 2

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

Treatments: Drug: 852A

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00319748

06US03IMP-852A

MT2006-02 (Other Identifier)

2006LS005 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Intent-To-Treat

Experimental group

Description:

Patients treated with at least one dose - 852A subcutaneous injection.

Treatment:

Drug: 852A

Evaluable Cohort

Experimental group

Description:

Patients who received all 24 doses of 852A per protocol.

Treatment:

Drug: 852A