Bethesda, Maryland 20892

  • Unspecified Adult Solid Tumor, Protocol Specific

Purpose:

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.


Study summary:

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.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed primary or metastatic cancer (other than melanoma, basal cell carcinoma, 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 significantly delay (i.e., > 2 weeks) scheduled standard therapy PATIENT CHARACTERISTICS: - ECOG performance status 0-1 - Platelet count > 100,000/mm^3 - Creatinine ≤ 1.4 mg/dL - SGOT and SGPT ≤ 2 times upper limit of normal (ULN) - Total bilirubin ≤ 2 times ULN (≤ 3.0 mg/dL in patients with Gilbert's syndrome) - Weight ≤ 350 pounds (160 kilograms) - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective nonhormonal contraception during and for 3 weeks after injection of study drug - No known allergy to trastuzumab - No active second malignancy except adequately treated basal cell skin carcinoma - No history of cardiac disease, including any of the following: - Myocardial infarction - Arrhythmia requiring therapy - Symptomatic valvular disease - Cardiomyopathy - Pericarditis - No coexisting medical or psychiatric condition that could limit study compliance - No severe claustrophobia PRIOR CONCURRENT THERAPY: - No nuclear medicine scan, except PET scan as part of on-study workup, during, and for 2 weeks after injection of study drug - Patients cannot have received another experimental drug within 14 days prior to or during study enrollment, with the exception of Hsp90 inhibitor AT13387 and PU-H71


NCT ID:

NCT00474578


Primary Contact:

Study Chair
Peter Choyke, MD
National Cancer Institute (NCI)


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States

Clinical Trials Office - Warren Grant Magnusen Clinical Center
Phone: 888-NCI-1937

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 27, 2022

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