111 Indium CHX-A DTPA Trastuzumab (Indium-Herceptin) for Imaging Breast Cancer

• Status: Terminated
• Trial end date: 2014-08-20
• Target enrollment: 0
• Participant gender: Female

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-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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Pentetic Acid; Trastuzumab

Criteria

• 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.