111 Indium CHX-A DTPA Trastuzumab (Indium-Herceptin) for Imaging Breast Cancer
Background: * Some breast cancer cells have specific proteins (receptors) on their surface that make the tumor grow faster than normal cells. One of these receptors is called HER2/neu. * An FDA-approved drug called Herceptin attaches to HER2/neu if it is present on the cancer cell. * Indium-Herceptin is an agent in which a tiny amount of radioactivity called Indium has been attached to a tiny amount of Herceptin. Objectives: -To see if Indium-Herceptin provides information about the characteristics of the breast cancer in women whose tumors express HER2/neu and those whose tumors do not. Eligibility: -Women 18 years or older with primary or metastatic breast cancer who have not received treatment with herceptin for at least 6 months before enrollment into the study. Design: * Tissue from the patient s original breast or tumor biopsy is analyzed for HER2/neu status. * Patients have a physical examination and review of medical records. * Patients receive an injection of Indium-Herceptin, followed by scanning with a gamma camera that detects the radioactivity in the Indium-Herceptin. * Patients return to the clinic 1, 2, 3 and 7 days later for repeat imaging to determine the best time to image after injection of Indium-Herceptin. * Blood samples are obtained every day of scanning to monitor the effects, if any, of the Indium-Herceptin and to see how fast the agent leaves the body.
Checked against the public recordLast updated Mar 11, 2019 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Diagnostic
- Study type
- Interventional
- Phase
- Early Phase 1
- Sponsor
- National Cancer Institute (NCI)
- Interventions being studied
- Drug: 111Indium CHX-A
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
* INCLUSION CRITERIA: Participant must have histological confirmation of primary or metastatic cancer other than melanoma, basal cell carcinoma, sarcoma, or lymphoma. * Primary tumor or metastatic focus must be 1.5cm or greater in diameter as established by palpation, ultrasound, mammography, CT or MRI. * Participant must be 18 years or older. * Availability of tumor tissue (either from the initial primary tumor or from current tumor lesion) for performing IHC or FISH analysis for HER2/Neu (Erb2) * Chemistry and CBC parameters: serum creatinine less than or equal to 1.4mg/dl. SGOT and SGPT less than or equal to 3 times of the upper limits of normal; total bilirubin, of less than or equal to 2 times the upper limits of normal or 3.0 mg/dl in patients with Gilbert s syndrome; platelet count must be greater than 100,00. * ECOG Performance score of 0 or 1. * Ability to provide informed consent. * Negative serum pregnancy test (within 48 hours of imaging agent injection) in women of child bearing age and willingness to use contraception (barrier, abstinence, non-hormonal) for 3 weeks after injection of (111)Indium trastuzumab if participant is of child bearing age. EXCLUSION CRITERIA: * Known allergy to trastuzumab. * Pregnant or lactating women. * Participants for whom enrollment would significantly delay (greater than 2 weeks) the scheduled standard of care therapy. * Participants with an active second malignancy (excluding treated basal cell skin carcinoma). * History of cardiac disease (myocardial infarction, arrhythmias requiring therapy, symptomatic valvular disease, cardiomyopathy, or pericarditis). * Participants with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results. * Participants with severe claustrophobia. * A participant who needs a nuclear medicine scan other than a PET scan as part of their work-up cannot enroll until these scans have been completed. * Gamma-camera table restrictions preclude scanning participants greater than 350 lbs (160 Kg) * With the exception of AT13387 and PU-H71, and Ad5f35HER2ECTM transduced autologous dendritic cell vaccine participants cannot have received another experimental drug within 14 days prior to or during study enrollment.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 11, 2019. Always confirm current availability with the study team.