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Status:

COMPLETED

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

Lead Sponsor:

Jonsson Comprehensive Cancer Center

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Breast Cancer

Eligibility:

FEMALE

18+ years

Phase:

PHASE1

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 s...

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...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    May 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    December 1 2007

    Estimated Enrollment :

    24 Patients enrolled

    Trial Details

    Trial ID

    NCT00096057

    Start Date

    May 1 2004

    End Date

    December 1 2007

    Last Update

    June 26 2013

    Active Locations (3)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (3 locations)

    1

    Jonsson Comprehensive Cancer Center at UCLA

    Los Angeles, California, United States, 90095-1781

    2

    University of Colorado Cancer Center at UC Health Sciences Center

    Aurora, Colorado, United States, 80045

    3

    M.D. Anderson Cancer Center at University of Texas

    Houston, Texas, United States, 77030-4009