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

NCT00096057 | Completed Phase 1

• 3 other identifiers: ROCHE-NP17787UCLA-0402065-01CDR0000391212
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

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.

Conditions

Breast Cancer

Keywords

recurrent breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IV breast cancer

Interventions

monoclonal antibody HuHMFG1 BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

University of Colorado Cancer Center at UC Health Sciences Center

Aurora, Colorado, 80045, United States

Location

M.D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

Related Publications (1)

• 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.

  PMID: 19811637 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

epitumomab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mark D. Pegram, MD

  Jonsson Comprehensive Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 9, 2004
• First Posted: November 9, 2004
• Study Start: May 1, 2004
• Study Completion: December 1, 2007
• Last Updated: June 26, 2013

Record last verified: 2007-04

Locations

US (3)