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

NCT01445054 | Terminated Early Phase 1 FDA Drug

• 2 other identifiers: 07010107-C-0101
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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-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.

Conditions

Breast Cancer; Prostate Cancer; Lung Cancer; Colon Cancer

Keywords

111 Indium Trastuzumab Imaging; PET; Optimal Scanning Strategy; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Compare uptake of 111Indium-CHX-A DTPA trastuzumab with HER2/Neu (ErbB2) status of the tumor as determined by IHC

  Correlation between uptake of 111Indium-CHX-A DTPA trastuzumab with HER2/Neu (ErbB2) and status of the tumor as determined by IHC

  5 days after intervention

Secondary Outcomes (5)

• Safety of 111Indium-trastuzumab.

  30 days after intervention

• Optimal timing of 111Indium-CHX-A DTPA trastuzumab imaging as a function of HER2/ Neu(ErbB2) status.

  completion of study

• Biodistribution of the agent in normal organs

  completion of study

• Pharmacokinetic serum clearance of 111Indium-CHXA DTPA trastuzumab

  24 hours after intervention

• To evaluate the change in 111Indium-CHX-A DTPA trastuzumab uptake in tumors following treatment with a HER2 targeted therapy

  completion of study

Study Arms (1)

1-Arm 1

EXPERIMENTAL

Subjects with primary or metastatic cancer other than melanoma, basal cell carcinoma, sarcoma, or lymphoma.

Drug: 111Indium CHX-A

Interventions

111Indium CHX-A DRUG

111Indium CHX-A will be administered intravenously over a 10-15 minute period using an intravenous catheter

1-Arm 1

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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. doi: 10.1158/1078-0432.CCR-04-1226.

  PMID: 15585615 BACKGROUND

• 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. doi: 10.1023/a:1006111117877.

  PMID: 10066073 BACKGROUND

• 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. doi: 10.1093/annonc/12.suppl_1.s15.

  PMID: 11521715 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Prostatic Neoplasms; Lung Neoplasms; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Peter L Choyke, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2011
• First Posted: October 3, 2011
• Study Start: March 1, 2007
• Primary Completion: August 20, 2014
• Study Completion: August 20, 2014
• Last Updated: March 11, 2019

Record last verified: 2019-03-07

Locations

US (1)