Breast Imaging Using Indium In 111 CHX-A DTPA Trastuzumab in Patients With Primary Cancer or Metastatic Cancer - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00474578

Purpose

RATIONALE: Using indium In 111 CHX-A DTPA trastuzumab in imaging procedures may help find certain types of cancer.

PURPOSE: This early phase I trial is studying breast imaging using indium In 111 CHX-A DTPA trastuzumab in patients with primary cancer or metastatic cancer.

Condition	Intervention	Phase
Unspecified Adult Solid Tumor, Protocol Specific	Genetic: fluorescence in situ hybridization Other: diagnostic laboratory biomarker analysis Other: immunohistochemistry staining method Other: pharmacological study Procedure: diagnostic imaging technique Radiation: indium In 111 CHX-A DTPA trastuzumab	Phase I

Study Type:	Interventional
Study Design:	Primary Purpose: Diagnostic
Official Title:	A Phase 0 Trial of "111 Indium CHX-A" DTPA Trastuzumab Imaging in Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Trastuzumab

U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:

Correlation of drug uptake with HER2 status as determined by fluorescent in situ hybridization (FISH) [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety [ Designated as safety issue: Yes ]
Optimal timing of drug imaging [ Designated as safety issue: No ]
Correlation of drug uptake with HER2 status as determined by immunohistochemistry [ Designated as safety issue: No ]
Biodistribution of drug in normal organs [ Designated as safety issue: No ]
Pharmacokinetics [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	June 2007

Detailed Description:

OBJECTIVES:

Primary

Correlate the uptake of indium In 111 CHX-A DTPA trastuzumab (indium In 111 Herceptin^®) with HER2 status as determined by fluorescent in situ hybridization (FISH) in patients with primary or metastatic cancer.

Secondary

Determine the safety of this drug in these patients.
Determine the optimal timing of drug imaging as a function of HER2 status.
Determine the biodistribution of this drug in normal organs in these patients.
Determine the pharmacokinetic serum clearance of this drug in these patients.
To evaluate the change in 111Indium-CHX-A" DTPA trastuzumab uptake in tumors following treatment with a HER2-targeted therapy. (exploratory)

OUTLINE: This is a pilot study. Patients are stratified according to HER2 status by fluorescent in situ hybridization (FISH) (negative vs positive).

Patients receive indium In 111 CHX-A DTPA trastuzumab (indium In 111 Herceptin^®) IV over 10-15 minutes. Patients undergo imaging scans at approximately 2-4, 48, 72, and 168 hours after infusion. Spot breast images (including recently biopsied lesion for metastatic disease), whole-body gamma scintigraphy, and single-photon emission-computed tomography are obtained at each of the above time points.

Patients undergo blood collection at baseline, immediately after infusion, and at 1, 2, 4, 48, 72, and 168 hours after infusion for toxicity evaluation and pharmacokinetic studies. Blood samples are examined by FISH and immunohistochemistry.

After completion of study injection, patients are followed at 30 days.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed primary or metastatic cancer (other than melanoma, basal cell carcinoma, or lymphoma)
Primary tumor or metastatic focus must be ≥1.5 cm in diameter by palpation, ultrasound, mammography, MRI, or CT scan
Tumor tissue must be available (either from the initial primary tumor or from current tumor lesion) for fluorescent in situ hybridization (FISH) and immunohistochemistry (IHC) analysis
- HER2/neu expression demonstrating 0, 1+, 2+, or 3+ by IHC
Participation in this study must not significantly delay (i.e., > 2 weeks) scheduled standard therapy

PATIENT CHARACTERISTICS:

ECOG performance status 0-1
Platelet count > 100,000/mm^3
Creatinine ≤ 1.4 mg/dL
SGOT and SGPT ≤ 2 times upper limit of normal (ULN)
Total bilirubin ≤ 2 times ULN (≤ 3.0 mg/dL in patients with Gilbert's syndrome)
Weight ≤ 350 pounds (160 kilograms)
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective nonhormonal contraception during and for 3 weeks after injection of study drug
No known allergy to trastuzumab
No active second malignancy except adequately treated basal cell skin carcinoma
No history of cardiac disease, including any of the following:
- Myocardial infarction
- Arrhythmia requiring therapy
- Symptomatic valvular disease
- Cardiomyopathy
- Pericarditis
No coexisting medical or psychiatric condition that could limit study compliance
No severe claustrophobia

PRIOR CONCURRENT THERAPY:

No nuclear medicine scan, except PET scan as part of on-study workup, during, and for 2 weeks after injection of study drug
Patients cannot have received another experimental drug within 14 days prior to or during study enrollment, with the exception of Hsp90 inhibitor AT13387 and PU-H71

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00474578

Locations

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office	Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair:

Peter Choyke, MD

National Cancer Institute (NCI)

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00474578 History of Changes
Other Study ID Numbers:	070101, CDR0000538995, NCI-07-C-0101, NCI-P6943
Study First Received:	May 16, 2007
Last Updated:	September 29, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institutes of Health Clinical Center (CC):

unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:

Pentetic Acid
Trastuzumab
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antidotes

Protective Agents
Physiological Effects of Drugs
Iron Chelating Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012