NIH Clinical Research Studies

Protocol Number: 07-C-0101

Active Accrual, Protocols Recruiting New Patients

Title:
A Phase 0 Trial of (111)Indium CHX-A" DTPA trastuzumab Imaging in Cancer
Number:
07-C-0101
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.

Sponsoring Institute:
National Cancer Institute (NCI)
Recruitment Detail
Type: Participants currently recruited/enrolled
Gender: Female
Referral Letter Required: No
Population Exclusion(s): Male

Children

Eligibility 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 analysis for HER2/Neu (Erb2)

OR

the participant must provide permission to undergo tumor biopsy (limited to superficial lesions, no intra-cavity sites will be biopsied) for IHC studies.

-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, within normal limits; platelet count must be greater than 100,000.

-ECOG Performance score of 0 or 1.

-Ability to provide informed consent.

-Negative pregnancy test (serum or urine beta-HCG) 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.

-Willingness and ability to return for studies at 2-4 hours and approximately 48, 72 and 168 hours after beginning the study. Each time is bracketed by plus or minus 4 hours.

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 who require anticoagulants

-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)

Special Instructions:
Currently Not Provided
Keywords:
Exploratory IND
Gamma Camera
SPECT Imaging
Radionuclide
Antibody Imaging
Recruitment Keyword(s):
Breast Cancer
Condition(s):
Breast Cancer
Investigational Drug(s):
111 Indium CHX-A DTPA-Trastuzumab
Investigational Device(s):
None
Intervention(s):
Drug: 111 Indium CHX-A DTPA-Trastuzumab
Drug: 111Indium Trastuzumab
Supporting Site:
National Cancer Institute

Contact(s):
NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
Phone: 1-888-NCI-1937
Fax: Not Listed
Electronic Address: ncicssc@mail.nih.gov

Citation(s):
Milenic DE, Garmestani K, Brady ED, Albert PS, Ma D, Abdulla A, Brechbiel MW. Targeting of HER2 antigen for the treatment of disseminated peritoneal disease. Clin Cancer Res. 2004 Dec 1;10(23):7834-41.

Pegram MD, Pauletti G, Slamon DJ. HER-2/neu as a predictive marker of response to breast cancer therapy. Breast Cancer Res Treat. 1998;52(1-3):65-77. Review.

Menard S, Casalini P, Campiglio M, Pupa S, Agresti R, Tagliabue E. HER2 overexpression in various tumor types, focussing on its relationship to the development of invasive breast cancer. Ann Oncol. 2001;12 Suppl 1:S15-9. Review.

Active Accrual, Protocols Recruiting New Patients

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