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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT00319748
First received: April 27, 2006
Last updated: January 4, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Ovarian Cancer
Endometrial Cancer
Cervical Cancer
Drug: 852A
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of 852A Administered Subcutaneously in Patients With Metastatic Refractory Breast, Ovarian, Endometrial and Cervical Cancers

Resource links provided by NLM:


Further study details as provided by Masonic Cancer Center, University of Minnesota:

Primary Outcome Measures:
  • Patients With Tumor Response (Response Evaluation Criteria in Solid Tumors) Who Received All 24 Doses of 852A. [ Time Frame: after 12 weeks (24 doses of 852A) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean Difference Values for Interleukin 1 Receptor Antagonist (IKL1ra) [ Time Frame: Prior to Dose 1 and 6 hours after Dose 1 ] [ Designated as safety issue: No ]
  • Mean Difference Values for 10 kDa Interferon-gamma-induced Protein (IP-10) [ Time Frame: Prior to Dose 1 and 6 Hours Post-Dose ] [ Designated as safety issue: No ]
  • Mean Difference Values for Macrophage Inflammatory Protein-1 Alpha (MIP-1a) [ Time Frame: Prior to Dose 1 and 6 Hours Post-Dose ] [ Designated as safety issue: No ]
  • Mean Difference Values for Macrophage Inflammatory Protein-1 Beta (MIP-1b) [ Time Frame: Prior to Dose 1 and 6 Hours Post-Dose ] [ Designated as safety issue: No ]
  • Mean Difference Values for Soluble CD40 Ligand (sCD40L) [ Time Frame: Prior to Dose 1 and 6 Hours Post-Dose ] [ Designated as safety issue: No ]
  • Mean Difference Values for Tumor Necrosis Factor-alpha (TNF-a) [ Time Frame: Prior to Dose 1 and 6 Hours Post-Dose ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: April 2006
Study Completion Date: December 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intent-To-Treat
Patients treated with at least one dose - 852A subcutaneous injection.
Drug: 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.
Other Names:
  • TLR-7
  • Toll-like receptor-7
Experimental: Evaluable Cohort
Patients who received all 24 doses of 852A per protocol.
Drug: 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.
Other Names:
  • TLR-7
  • Toll-like receptor-7

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00319748

Locations
United States, Minnesota
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Pfizer
Investigators
Principal Investigator: Sarah Cooley, MD Masonic Cancer Center, University of Minnesota
Principal Investigator: Melissa A. Geller, MD Masonic Cancer Center, University of Minnesota
  More Information

No publications provided

Responsible Party: Melissa Geller, M.D., Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00319748     History of Changes
Obsolete Identifiers: NCT00363493
Other Study ID Numbers: 06US03IMP-852A, MT2006-02, 2006LS005
Study First Received: April 27, 2006
Results First Received: August 17, 2009
Last Updated: January 4, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Masonic Cancer Center, University of Minnesota:
Breast
Ovarian
Endometrial
Cervical
Metastatic
852A
IRM
Oncology
Metastatic Cervical Cancer
Metastatic Ovarian Cancer
Metastatic Breast Cancer
Metastatic Endometrial Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Endometrial Neoplasms
Uterine Cervical Neoplasms
Ovarian Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Diseases
Genital Diseases, Female
Uterine Cervical Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on July 28, 2014