Phase II Study of Combidex in Axillary Node Staging in Breast Cancer
18 Years
N/A
Both
Breast Cancer
Trial Information
Phase II Study of Combidex in Axillary Node Staging in Breast Cancer
OBJECTIVES:
Primary
- Determine the utility of magnetic resonance (MR) imaging using ferumoxtran-10 in
identifying metastases to the axillary lymph nodes in patients with invasive breast
cancer.
Secondary
- Determine the changes in MR T1 and T2 signal intensity in primary breast tumors after
administration of this drug to these patients.
- Determine the potential of delayed imaging, in terms of defining tumor boundaries, in
these patients.
OUTLINE: Patients receive ferumoxtran-10 IV over 25-30 minutes on day 0 in the absence of
unacceptable toxicity. Patients undergo MRI of the involved breast and ipsilateral axilla on
day 0 (once before and once after ferumoxtran-10 administration) and then once on day 1.
Within 3 weeks after the completion of imaging studies, patients undergo sentinel lymph node
biopsy. If the sentinel node is positive for malignancy on touch prep, an axillary lymph
node dissection is performed if clinically indicated.
Patients are followed at approximately 1 month after surgery.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 8.3 months.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed invasive breast cancer
- Candidate for sentinel lymph node biopsy and/or axillary lymph node dissection
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age
- 18 and over
Sex
- Male or female
Menopausal status
- Not specified
Performance status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- WBC ≥ 3,000/mm^3
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count > 100,000/mm^3
- Ferritin ≤ 350 ng/mL*
- Transferrin saturation level ≤ 40%* NOTE: *Patients with lab values above these
limits may be eligible provided there is no hemochromatosis by hematology
consultation
Hepatic
- Bilirubin normal
- AST and ALT ≤ 2.5 times upper limit of normal
- Alkaline phosphatase normal
- PT normal
- Albumin normal
- No history of cirrhosis
Renal
- Creatinine normal OR
- Creatinine clearance > 60 mL/min
Cardiovascular
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
Other
- Not pregnant or nursing
- Negative pregnancy test
- Medically stable
- No ongoing or active infection
- No history of allergic reaction attributed to compounds of similar chemical or
biological composition to ferumoxtran-10 (e.g., iron preparations, parenteral iron,
parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide
preparations)
- No history of allergic reaction to any contrast media
- No immunodeficiency that would predispose patient to a specific or non-specific
mediator release
- No contraindication to MRI, including any of the following:
- Severe claustrophobia
- Pacemaker
- Aneurysm clips
- Defibrillators
- Certain types of replacement joints
- Other institutional contraindication to MRI
- No psychiatric illness or social situation that would preclude study compliance
- No other uncontrolled illness
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- More than 30 days since prior investigational agents
- More than 3 months since prior ferumoxides
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Utility of magnetic resonance imaging using ferumoxtran-10 in identifying metastases to axillary lymph nodes
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Karen A. Kurdziel, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Massey Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000420833
NCT ID:
NCT00107484
Start Date:
September 2005
Completion Date:
October 2006
Related Keywords:
- Breast Cancer
- stage IV breast cancer
- stage I breast cancer
- stage II breast cancer
- stage IIIA breast cancer
- stage IIIB breast cancer
- stage IIIC breast cancer
- male breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Massey Cancer Center at Virginia Commonwealth University | Richmond, Virginia 23298-0037 |
