Radioactive Iodide (131I) Treatment of 124I PET/CT Detected Breast Cancers

Breast Cancer Clinical Trial

Official title:

Radioactive Iodide (131I) Treatment of 124I PET/CT Detected Breast Cancers

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01360177
• Other study ID #: BRSMTS0012
• Secondary ID: SU-07292008-1271
• Status: Withdrawn
• Phase: N/A
• First received: April 18, 2011
• Last updated: July 18, 2016
• Start date: July 2010
• Est. completion date: December 2014

Study information

• Verified date: July 2016
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is a treatment protocol designed to accompany the ongoing institutional 124I PET/CT pilot imaging study for patients with invasive breast cancer. Women whose tumors express NIS [Na+I- symporter, sodium iodide symporter] and demonstrate radioiodide uptake on 124I PET/CT scans will be eligible for 131I treatment if, (1) tumor dosimetry calculations yield a cumulative radiation dose of at least 30Gy in target tumor, (2) estimated cumulative thyroid irradiation is less than 500 cGy and, (3) the therapeutic dose of 131I is in the range of 25 to 100 mCi.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with measurable locally advanced or metastatic breast cancer who completed 124I PET/CT imaging study.

• Patients who are 18 years of age or older.

• Patients must have a life expectancy of at least 3 months.

• I 124 dosimetry completed with thyroid dose to 500 cGy or less and tumor dose of 2500 cGy or more.

• I131 therapeutic dose calculated from dosimetry. Dose must be in a range of 25 to 150 mCi.

• Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status 0-3 will be eligible.

• Use of concurrent systemic therapy (hormonal or cytotoxic) if associated with stable disease for at least three months prior to treatment.

• Women with locally advanced breast cancer and simultaneous metastases, even if surgery to eradicate local disease has taken place.

• Thyroid stimulating hormone (TSH) must be < 0.4 uIU/mL.

• White blood cell count >= 1,500 and platelet count >= 40,000

• Women receiving thyroid hormone supplements and methimazole.

• Ability to understand and the willingness to sign a written informed consent document.

• Premenopausal women must use contraception while receiving this treatment and during follow-up period of 42 days.

Exclusion Criteria:

• Stage 0-II breast cancer.

• Pregnant or nursing women.

• Not able to sign informed consent.

• Untreated psychiatric disorder.

• Women who have not had I124 PET/CT scan and dosimetry calculations.

• Radioiodide uptake in non-target organs or bone marrow does not exceed 25 cGy by pre-treatment dosimetry.

• Received chemotherapy less than 4 weeks before.

• History of thyroid cancer.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Procedure:
• 124 PET/CT imaging
Standard of Care

Drug:
• Na134I
25 to 150 mCi
• Tri-iodothyronine
75 ug/8hr x 4 weeks; oral
• Tri-iodothyronine
20 mg/day x 2

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target lesion size will be assessed clinically or radiologically in two directions . RECIST (Response Evaluation Criteria In Solid Tumors) will be implemented to determine response	cCR (complete clinical response) = disappearance of all tumor; cPR (clinical partial response) = >=30% decrease sum of longest target lesion diameters; cPD (progressive disease) = >=20% increase sum of longest target lesion diameters.; cSD (stable disease) = small changes that do not meet these criteria	6 WEEKS POST-TREATMENT	No
Secondary	Non target lesion size will be assessed clinically or radiologically in two directions . RECIST (Response Evaluation Criteria In Solid Tumors) will be implemented to determine response	Complete Response (CR): Disappearance of all non-target lesions; Incomplete Response/Stable Disease (SD): Persistence of one or more non-target lesions(s); Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions	EVALUATED AT 6 WEEKS	No