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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01360177
First received: April 18, 2011
Last updated: April 22, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Breast Cancer
Metastatic Breast Cancer
Procedure: 124 PET/CT imaging
Drug: Na134I
Drug: Tri-iodothyronine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Radioactive Iodide (131I) Treatment of 124I PET/CT Detected Breast Cancers

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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 [ Time Frame: 6 WEEKS POST-TREATMENT ] [ Designated as safety issue: No ]
    • 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


Secondary Outcome Measures:
  • 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 [ Time Frame: EVALUATED AT 6 WEEKS ] [ Designated as safety issue: No ]
    • 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


Enrollment: 0
Study Start Date: July 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radioactive Iodide and PET/CT Procedure: 124 PET/CT imaging
Standard of Care
Other Name: Positron emission tomography - computed tomography
Drug: Na134I
25 to 150 mCi
Other Name: GE Healthcare
Drug: Tri-iodothyronine
75 ug/8hr x 4 weeks; oral
Other Name: T3
Drug: Tri-iodothyronine
20 mg/day x 2
Other Name: T3

  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01360177

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Irene L. Wapnir Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01360177     History of Changes
Other Study ID Numbers: BRSMTS0012, SU-07292008-1271, 14941
Study First Received: April 18, 2011
Last Updated: April 22, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 23, 2014