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Monoclonal Antibody HuHMFG1 in Treating Women With Locally Advanced or Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00096057
Recruitment Status : Completed
First Posted : November 9, 2004
Last Update Posted : June 26, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE November 9, 2004
First Posted Date  ICMJE November 9, 2004
Last Update Posted Date June 26, 2013
Study Start Date  ICMJE May 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Monoclonal Antibody HuHMFG1 in Treating Women With Locally Advanced or Metastatic Breast Cancer
Official Title  ICMJE An Open Label Phase I Study of Humanized Human Milk Fat Globule-1 (huHMFG1) Antibody in Patients With Locally Advanced or Metastatic Breast Cancer (TOPCAT)
Brief Summary

RATIONALE: Monoclonal antibodies such as HuHMFG1 can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: This phase I trial is studying the side effects and best dose of monoclonal antibody HuHMFG1 in treating women with locally advanced or metastatic breast cancer.

Detailed Description

OBJECTIVES:

  • Determine the safety and tolerability of monoclonal antibody HuHMFG1 in women with locally advanced or metastatic breast cancer.
  • Determine a safe recommended dose and schedule of this drug in these patients.
  • Determine the pharmacokinetic profile, in the absence of any other chemotherapy or endocrine agent, of this drug in these patients.
  • Determine the antitumor activity of this drug in these patients.
  • Determine time to progression in patients treated with this drug.
  • Assess immunological markers (e.g., granzyme B, gamma interferon, and C1Q) for determining response to this drug in these patients.
  • Assess markers of immunogenicity (e.g., human anti-human antibody) of this drug in these patients.
  • Assess tumor markers (e.g., CA15.3 and CEA) in patients treated with this drug.
  • Correlate, preliminarily, soluble HMFG1 antigen levels with pharmacokinetic data for this drug in these patients.

OUTLINE: This is an open-label, non-randomized, dose-escalation study.

Patients in cohorts 1 and 2 receive monoclonal antibody HuHMFG1 IV over 1-3 hours once every 21 days for doses 1 and 2. All subsequent dose intervals are based on individual half-life value of the drug, to be within 3 days of the estimated half-life in multiples of 7 days. Patients in cohorts 3 and 4 receive monoclonal antibody HuHMFG1 at the dosing interval determined in the first 2 cohorts. Treatment continues in the absence of disease progression or unacceptable toxicity.

Cohorts of 6 patients receive escalating doses of monoclonal antibody HuHMFG1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.

All patients are followed at 4 weeks and then every 6 weeks for 6 months. Patients with an antitumor response or stable disease are followed every 12 weeks until disease progression or initiation of another antitumor treatment.

PROJECTED ACCRUAL: A total of 6-24 patients will be accrued for this study within 18 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE Biological: monoclonal antibody HuHMFG1
Study Arms  ICMJE Not Provided
Publications * Pegram MD, Borges VF, Ibrahim N, Fuloria J, Shapiro C, Perez S, Wang K, Schaedli Stark F, Courtenay Luck N. Phase I dose escalation pharmacokinetic assessment of intravenous humanized anti-MUC1 antibody AS1402 in patients with advanced breast cancer. Breast Cancer Res. 2009;11(5):R73. doi: 10.1186/bcr2409.

*   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
Estimated Enrollment  ICMJE
 (submitted: November¬†8,¬†2006)
24
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed breast cancer

    • Locally advanced or metastatic disease
    • No inflammatory breast cancer
  • Measurable (RECIST) or evaluable disease (e.g., cytologically or radiologically detectable disease that does not fulfill RECIST criteria)
  • Failed prior OR not a candidate for OR refused anthracycline- and taxane-containing chemotherapy
  • Patients whose tumor overexpresses HER-2 must have failed prior trastuzumab (Herceptin®)
  • No known CNS metastases
  • No metastases accessible to complete surgical resection
  • Unstained slides cut from formalin-fixed and paraffin-embedded tumor blocks available

    • Appropriate tumor block also acceptable
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Sex

  • Female

Menopausal status

  • Not specified

Performance status

  • WHO 0-1

Life expectancy

  • At least 4 months

Hematopoietic

  • Hemoglobin ≥ 10 g/dL
  • Absolute neutrophil count ≥ 1,500/mm^3
  • WBC ≥ 1,000/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin ≤ 1.5 mg/dL
  • ALT or AST ≤ 2.5 times upper limit of normal (ULN) (< 5 times ULN in patients with liver metastases) OR
  • Alkaline phosphatase ≤ 2.5 times ULN (< 5 times ULN in patients with liver metastases)

    • Any degree of elevated alkaline phosphatase allowed provided it is due to bone metastases

Renal

  • Creatinine ≤ 1.5 times ULN OR
  • Creatinine clearance > 60 mL/min
  • Uric acid < 1.25 times ULN (for patients with hyperuricemia only)
  • Calcium (corrected for serum albumin) < 11.5 mg/dL (for patients with hypercalcemia only)

Cardiovascular

  • LVEF ≥ 45% by MUGA or echocardiogram within the past 4 weeks

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception
  • No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or cervical intra-epithelial neoplasia
  • No other uncontrolled illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • Prior biological therapy allowed
  • More than 2 weeks since prior blood transfusions or growth factors to aid hematological recovery
  • No other concurrent antitumor immunotherapy

Chemotherapy

  • See Disease Characteristics
  • More than 4 weeks since prior cytotoxic chemotherapy
  • No more than 3 prior chemotherapy regimens, including adjuvant/neoadjuvant therapy
  • No concurrent antitumor chemotherapy

Endocrine therapy

  • Prior hormonal therapy allowed
  • No concurrent corticosteroids except as physiologic replacement and/or for acute short-term treatment of, or prophylaxis against, infusion reactions
  • No concurrent antitumor hormonal therapy

Radiotherapy

  • See Disease Characteristics
  • More than 4 weeks since prior radiotherapy (except for palliative radiotherapy)
  • No concurrent antitumor radiotherapy, except for palliation to non-study lesions

    • Irradiated area should be as small as possible and involve ≤ 10% of the bone marrow in any given 4-week period

Surgery

  • More than 4 weeks since prior major surgery

Other

  • More than 30 days since prior investigational agents
  • No other concurrent investigational agents
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
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 NCT00096057
Other Study ID Numbers  ICMJE ROCHE-NP17787
UCLA-0402065-01
CDR0000391212 ( Registry Identifier: PDQ (Physician Data Query) )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Jonsson Comprehensive Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Mark D. Pegram, MD Jonsson Comprehensive Cancer Center
PRS Account National Cancer Institute (NCI)
Verification Date April 2007

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