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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00474578 |
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.
Condition | Intervention | Phase |
---|---|---|
Unspecified Adult Solid Tumor, Protocol Specific |
Genetic: fluorescence in situ hybridization Other: immunohistochemistry staining method Other: laboratory biomarker analysis Other: pharmacological study Procedure: imaging technique Procedure: radionuclide imaging Procedure: single photon emission computed tomography Radiation: indium In 111 CHX-A DTPA trastuzumab |
Phase I |
Study Type: | Interventional |
Study Design: | Diagnostic |
Official Title: | A Phase 0 Trial of Indium CHX-A" DTPA Trastuzumab Imaging in Cancer |
Estimated Enrollment: | 20 |
Study Start Date: | June 2007 |
Estimated Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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
PATIENT CHARACTERISTICS:
No history of cardiac disease, including any of the following:
PRIOR CONCURRENT THERAPY:
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 |
Study Chair: | Peter Choyke, MD | National Cancer Institute (NCI) |
Study ID Numbers: | CDR0000538995, NCI-07-C-0101, NCI-P6943 |
Study First Received: | May 16, 2007 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00474578 History of Changes |
Health Authority: | Unspecified |
unspecified adult solid tumor, protocol specific |
Trastuzumab Neoplasm Metastasis |
Antineoplastic Agents Therapeutic Uses Trastuzumab Pharmacologic Actions |