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

• Register: ClinicalTrials.gov
• Last refreshed on: 15 April 2013
• Main ID: NCT01445054
• Date of registration: 30/09/2011
• Primary sponsor: National Cancer Institute (NCI)
• Public title: 111 Indium CHX-A DTPA Trastuzumab (Indium-Herceptin) for Imaging Breast Cancer
• Scientific title: A Phase 0 Trial of (111)Indium CHX-A DTPA Trastuzumab Imaging in Cancer
• Date of first enrolment: February 2007
• Target sample size: 20
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01445054
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Countries of recruitment

United States

Contacts

• Name: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office

• Name: Yolanda McKinney, R.N.

• Name: Peter L Choyke, M.D.
• Affiliation: National Institutes of Health Clinical Center (CC)

Key inclusion & exclusion 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 2 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer

Intervention(s)

Drug: 111Indium Trastuzumab

Radiation: 111 Indium CHX-A DTPA-Trastuzumab

Primary Outcome(s)

Correlation of uptake with HER2/neu status of tumor. [Time Frame: No]

Secondary Outcome(s)

Establish safety of 111 Indium Trastuzumab, determine the optimal timing of imaging as a function of HER2 status and correlate uptake with traditional IHC assessment of HER2 status, biodistribution.

Secondary ID(s)

07-C-0101

070101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors