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Investigator(s):
Peter Choyke, M.D., F.A.C.R. Principal Investigator Phone: 301-451-4220 pchoyke@mail.cc.nih.gov	Antonio Tito Fojo, M.D., Ph.D. Protocol Chair Phone: 301-402-1357 tfojo@helix.nih.gov
Referral Contact(s):
Yolanda McKinney, R.N., B.S.N. Research Nurse Phone: 301-443-1718 ymckinney@mail.nih.gov

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Primary Eligibility:

• Histologically confirmed primary or metastatic cancer (other than melanoma, basal cell carcinoma, sarcoma, or lymphoma)
• Primary tumor or metastatic focus must be ≥ 1.5 cm in diameter by palpation, ultrasound, mammography, MRI, or CT scan
• Tumor tissue must be available (either from the initial primary tumor or from current tumor lesion) for fluorescent in situ hybridization (FISH) and immunohistochemistry (IHC) analysis
• HER2/neu expression demonstrating 0, 1+, 2+, or 3+ by IHC
• Participation in this study must not delay scheduled standard therapy > 2 weeks
• No concurrent anticoagulants
• No nuclear medicine scan, except PET scan as part of on-study workup, during and for 2 weeks after injection of study drug
• Platelet count > 100,000/mm³
• Creatinine ≤ 1.4 mg/dL
• SGOT and SGPT ≤ 2 times upper limit of normal
• Bilirubin normal
• No history of cardiac disease, myocardial infarction, arrhythmias requiring therapy, symptomatic valvular disease, cardiomyopathy, or pericarditis
• ECOG Performance Status of 0 or 1
• Not pregnant or breast feeding
• Fertile patients must use effective non-hormonal contraception during and for 3 weeks after injection of study drug
• No known allergy to trastuzumab
• No chronic steroid therapy
• No active second malignancy (excluding treated basal cell skin carcinoma)
• Weight < 350 lbs (160 kg)
• No severe claustrophobia
• Willingness and ability to return for studies at approximately 2–4, 48, 72 and 168 hours after beginning the study

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Treatment Plan:

The design of this pilot trial follows the concept of a Phase 0 or exploratory IND study.

• 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 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
• Images will be correlated with FISH/IHC status and the optimal scanning strategy with regard to HER2 expression will be determined

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 10/24/08
Updated: 10/24/08