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

NCT00319748

Last updated date
Study Location
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Cancer, Ovarian Cancer, Endometrial Cancer, Cervical Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Breast Cancer, Ovarian Cancer, Endometrial Cancer, Cervical CancerStudy of Immune Response Modifier in the Treatment of Breast, Ovarian, Endometrial and Cervical Cancers
NCT00319748
  1. Minneapolis, Minnesota
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study of Immune Response Modifier in the Treatment of Breast, Ovarian, Endometrial and Cervical Cancers
Official Title  ICMJE Phase II Study of 852A Administered Subcutaneously in Patients With Metastatic Refractory Breast, Ovarian, Endometrial and Cervical Cancers
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Cancer
  • Ovarian Cancer
  • Endometrial Cancer
  • Cervical Cancer
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: Intent-To-Treat
    Patients treated with at least one dose - 852A subcutaneous injection.
    Intervention: Drug: 852A
  • Experimental: Evaluable Cohort
    Patients who received all 24 doses of 852A per protocol.
    Intervention: Drug: 852A
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 14, 2009)
15
Original Enrollment  ICMJE
 (submitted: April 27, 2006)
40
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00319748
Other Study ID Numbers  ICMJE 06US03IMP-852A
MT2006-02 ( Other Identifier: Blood and Bone Marrow Transplantation Program )
2006LS005 ( Other Identifier: Masonic Cancer Center, University of Minnesota )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Melissa Geller, M.D., Masonic Cancer Center, University of Minnesota
Study Sponsor  ICMJE Masonic Cancer Center, University of Minnesota
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Sarah Cooley, MDMasonic Cancer Center, University of Minnesota
Principal Investigator:Melissa A. Geller, MDMasonic Cancer Center, University of Minnesota
PRS Account Masonic Cancer Center, University of Minnesota
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP