Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-01-04 @ 5:27 PM
Study NCT ID:
NCT00096057
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2004-11-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monoclonal Antibody HuHMFG1 in Treating Women With Locally Advanced or Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C547393', 'term': 'epitumomab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-04', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-25', 'studyFirstSubmitDate': '2004-11-09', 'studyFirstSubmitQcDate': '2004-11-08', 'lastUpdatePostDateStruct': {'date': '2013-06-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-11-09', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['recurrent breast cancer', 'stage IIIA breast cancer', 'stage IIIB breast cancer', 'stage IIIC breast cancer', 'stage IV breast cancer'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '19811637', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nPURPOSE: 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.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the safety and tolerability of monoclonal antibody HuHMFG1 in women with locally advanced or metastatic breast cancer.\n* Determine a safe recommended dose and schedule of this drug in these patients.\n* Determine the pharmacokinetic profile, in the absence of any other chemotherapy or endocrine agent, of this drug in these patients.\n* Determine the antitumor activity of this drug in these patients.\n* Determine time to progression in patients treated with this drug.\n* Assess immunological markers (e.g., granzyme B, gamma interferon, and C1Q) for determining response to this drug in these patients.\n* Assess markers of immunogenicity (e.g., human anti-human antibody) of this drug in these patients.\n* Assess tumor markers (e.g., CA15.3 and CEA) in patients treated with this drug.\n* Correlate, preliminarily, soluble HMFG1 antigen levels with pharmacokinetic data for this drug in these patients.\n\nOUTLINE: This is an open-label, non-randomized, dose-escalation study.\n\nPatients 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.\n\nCohorts 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.\n\nAll 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.\n\nPROJECTED ACCRUAL: A total of 6-24 patients will be accrued for this study within 18 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed breast cancer\n\n * Locally advanced or metastatic disease\n * No inflammatory breast cancer\n* Measurable (RECIST) or evaluable disease (e.g., cytologically or radiologically detectable disease that does not fulfill RECIST criteria)\n* Failed prior OR not a candidate for OR refused anthracycline- and taxane-containing chemotherapy\n* Patients whose tumor overexpresses HER-2 must have failed prior trastuzumab (Herceptin®)\n* No known CNS metastases\n* No metastases accessible to complete surgical resection\n* Unstained slides cut from formalin-fixed and paraffin-embedded tumor blocks available\n\n * Appropriate tumor block also acceptable\n* Hormone receptor status:\n\n * Not specified\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nSex\n\n* Female\n\nMenopausal status\n\n* Not specified\n\nPerformance status\n\n* WHO 0-1\n\nLife expectancy\n\n* At least 4 months\n\nHematopoietic\n\n* Hemoglobin ≥ 10 g/dL\n* Absolute neutrophil count ≥ 1,500/mm\\^3\n* WBC ≥ 1,000/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n\nHepatic\n\n* Bilirubin ≤ 1.5 mg/dL\n* ALT or AST ≤ 2.5 times upper limit of normal (ULN) (\\< 5 times ULN in patients with liver metastases) OR\n* Alkaline phosphatase ≤ 2.5 times ULN (\\< 5 times ULN in patients with liver metastases)\n\n * Any degree of elevated alkaline phosphatase allowed provided it is due to bone metastases\n\nRenal\n\n* Creatinine ≤ 1.5 times ULN OR\n* Creatinine clearance \\> 60 mL/min\n* Uric acid \\< 1.25 times ULN (for patients with hyperuricemia only)\n* Calcium (corrected for serum albumin) \\< 11.5 mg/dL (for patients with hypercalcemia only)\n\nCardiovascular\n\n* LVEF ≥ 45% by MUGA or echocardiogram within the past 4 weeks\n\nOther\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective barrier contraception\n* No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or cervical intra-epithelial neoplasia\n* No other uncontrolled illness that would preclude study participation\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* See Disease Characteristics\n* Prior biological therapy allowed\n* More than 2 weeks since prior blood transfusions or growth factors to aid hematological recovery\n* No other concurrent antitumor immunotherapy\n\nChemotherapy\n\n* See Disease Characteristics\n* More than 4 weeks since prior cytotoxic chemotherapy\n* No more than 3 prior chemotherapy regimens, including adjuvant/neoadjuvant therapy\n* No concurrent antitumor chemotherapy\n\nEndocrine therapy\n\n* Prior hormonal therapy allowed\n* No concurrent corticosteroids except as physiologic replacement and/or for acute short-term treatment of, or prophylaxis against, infusion reactions\n* No concurrent antitumor hormonal therapy\n\nRadiotherapy\n\n* See Disease Characteristics\n* More than 4 weeks since prior radiotherapy (except for palliative radiotherapy)\n* No concurrent antitumor radiotherapy, except for palliation to non-study lesions\n\n * Irradiated area should be as small as possible and involve ≤ 10% of the bone marrow in any given 4-week period\n\nSurgery\n\n* More than 4 weeks since prior major surgery\n\nOther\n\n* More than 30 days since prior investigational agents\n* No other concurrent investigational agents'}, 'identificationModule': {'nctId': 'NCT00096057', 'briefTitle': 'Monoclonal Antibody HuHMFG1 in Treating Women With Locally Advanced or Metastatic Breast Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'ROCHE-NP17787'}, 'secondaryIdInfos': [{'id': 'UCLA-0402065-01'}, {'id': 'CDR0000391212', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'monoclonal antibody HuHMFG1', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095-1781', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Jonsson Comprehensive Cancer Center at UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Cancer Center at UC Health Sciences Center', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '77030-4009', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M.D. Anderson Cancer Center at University of Texas', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Mark D. Pegram, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Jonsson Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jonsson Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}