Status:
TERMINATED
111 Indium CHX-A DTPA Trastuzumab (Indium-Herceptin) for Imaging Breast Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Prostate Cancer
Eligibility:
FEMALE
18-99 years
Phase:
EARLY_PHASE1
Brief Summary
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-appro...
Detailed Description
Background: * Trastuzumab (Herceptin ), targets HER2 (aka: neu, ErbB2, c-erb-B2) on the surface of cancer cells and is used in the treatment of breast cancers that overexpress HER2/Neu (Erb2). It has...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 20 2014
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01445054
Start Date
March 1 2007
End Date
August 20 2014
Last Update
March 11 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892