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

NCT ID: NCT00319748

Last Updated: 2019-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2008-12-31

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.

Conditions

Breast Cancer; Ovarian Cancer; Endometrial Cancer; Cervical Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intent-To-Treat

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

Group Type: EXPERIMENTAL

852A

Intervention Type: DRUG

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.

Evaluable Cohort

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

Group Type: EXPERIMENTAL

852A

Intervention Type: DRUG

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.

Interventions

852A

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.

Intervention Type: DRUG

Other Intervention Names

TLR-7; Toll-like receptor-7

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)

• 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.

• 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.

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Masonic Cancer Center, University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Masonic Cancer Center, University of Minnesota

Principal Investigators

Sarah Cooley, MD

Role: PRINCIPAL_INVESTIGATOR

Masonic Cancer Center, University of Minnesota

Melissa A. Geller, MD

Role: PRINCIPAL_INVESTIGATOR

Masonic Cancer Center, University of Minnesota

Locations

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

MT2006-02

Identifier Type: OTHER

Identifier Source: secondary_id

2006LS005

Identifier Type: OTHER

Identifier Source: secondary_id

06US03IMP-852A

Identifier Type: -

Identifier Source: org_study_id

NCT00363493

Identifier Type: -

Identifier Source: nct_alias