Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| P30CA077598 | U.S. NIH Grant/Contract | View source | |
| NCI-CDR0000589252 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Monoclonal antibodies, such as CP-751871, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
PURPOSE: This phase I trial is studying the side effects and best way to give CP-751871 in treating patients with early-stage breast cancer that can be removed by surgery.
Primary
Secondary
OUTLINE: Patients receive CP-751871 IV over 5 hours on days 1 and 22 and undergo magnetic resonance spectroscopy on days 8 and 29. Patients may also undergo surgery between days 29-43 to obtain a tumor sample for analysis of markers related to the IGR-1R pathway.
After completion of study treatment, patients will be followed for 5 months.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| figitumumab | Biological | |||
| imaging biomarker analysis | Other | |||
| laboratory biomarker analysis | Other | |||
| pharmacological study | Other | |||
| conventional surgery | Procedure | |||
| magnetic resonance spectroscopic imaging | Procedure | |||
| neoadjuvant therapy | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor total choline (tCho) changes determined by magnetic resonance spectroscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Safety, tolerability and human anti-human antibodies (HAHA) response | ||
| Tissue markers | ||
| Measure of tumor glucose levels |
Not provided
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Menopausal status not specified
ECOG performance status 0-1
Platelet count ≥ 100,000/mm^³
Neutrophil count ≥ 1,500/mm³
Creatinine < 1.5 times upper limit of normal (ULN)
Bilirubin < 1.5 times ULN
ALT and AST < 2.5 times ULN
Fertile patients must use adequate barrier method contraception during and for at least 150 days after completion of study treatment
Ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures
No known hypersensitivity to monoclonal antibodies
No prior or active malignancies other than curatively treated in situ carcinoma of the cervix, uterus, or basal cell or squamous cell carcinoma of the skin
No serious uncontrolled medical disorder or active infection that would impair the ability to receive study treatment
No significant active cardiac disease including any of the following:
No dementia or significantly altered mental status that would limit the understanding or rendering of informed consent and compliance with study requirements
PRIOR CONCURRENT THERAPY:
More than 4 weeks since prior surgery and recovered
More than 2 weeks since high-dose corticosteroid therapy (i.e., ≥ 100 mg prednisone per day or > 40 mg dexamethasone per day)
No prior anti-IGF-1R based investigational therapy
No prior systemic therapy for primary disease
No concurrent chronic systemic high-dose immunosuppressive steroid therapy
No concurrent other anticancer drugs or therapy
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Douglas Yee, MD | Masonic Cancer Center, University of Minnesota | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Pathological response |
| Tumor size by MRI |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C525021 | figitumumab |
| D009682 | Magnetic Resonance Spectroscopy |
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
Not provided
Not provided