Last updated on September 2011

Breast Imaging Using Indium In 111 CHX-A DTPA Trastuzumab in Patients With Primary Cancer or Metastatic Cancer


Brief description of study

RATIONALE: Using indium In 111 CHX-A DTPA trastuzumab in imaging procedures may help find certain types of cancer. PURPOSE: This early phase I trial is studying breast imaging using indium In 111 CHX-A DTPA trastuzumab in patients with primary cancer or metastatic cancer.

Detailed Study Description

OBJECTIVES: Primary - Correlate the uptake of indium In 111 CHX-A DTPA trastuzumab (indium In 111 Herceptin^®) with HER2 status as determined by fluorescent in situ hybridization (FISH) in patients with primary or metastatic cancer. Secondary - Determine the safety of this drug in these patients. - Determine the optimal timing of drug imaging as a function of HER2 status. - Determine the biodistribution of this drug in normal organs in these patients. - Determine the pharmacokinetic serum clearance of this drug in these patients. - To evaluate the change in 111Indium-CHX-A" DTPA trastuzumab uptake in tumors following treatment with a HER2-targeted therapy. (exploratory) OUTLINE: This is a pilot study. Patients are stratified according to HER2 status by fluorescent in situ hybridization (FISH) (negative vs positive). Patients receive indium In 111 CHX-A DTPA trastuzumab (indium In 111 Herceptin^®) IV over 10-15 minutes. Patients undergo imaging scans at approximately 2-4, 48, 72, and 168 hours after infusion. Spot breast images (including recently biopsied lesion for metastatic disease), whole-body gamma scintigraphy, and single-photon emission-computed tomography are obtained at each of the above time points. Patients undergo blood collection at baseline, immediately after infusion, and at 1, 2, 4, 48, 72, and 168 hours after infusion for toxicity evaluation and pharmacokinetic studies. Blood samples are examined by FISH and immunohistochemistry. After completion of study injection, patients are followed at 30 days. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Clinical Study Identifier: NCT00474578

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