A Clinical Trial Evaluating the Safety and Clinical Activity of Radioiodide (131I-) as a Novel Targeted Therapy for Metastatic Breast Cancer That Overexpresses Functional Na/I Symporter

NCT02988648 | Withdrawn Phase 1 DMC

• 1 other identifier: 1607018035
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this phase I/II study is to evaluate the safety and clinical activity of Radioiodide (131I-) as a novel targeted therapy for metastatic breast cancer that overexpresses functional Na/I symporter. The study will enroll patients with metastatic breast cancer who have had clinical and/or radiographic evidence of disease progression on prior hormonal and/or chemotherapy.

Conditions

Breast Cancer

Keywords

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• objective tumor response rate

  The primary efficacy measure is objective tumor response rate (CR or PR) with targeted activity level of \> 20% response rate. Patients should be followed regularly until disease progression and until resolution of all acute toxicities associated with treatment administration. If stable disease or resolution of toxicities takes longer than 24 weeks, follow up frequency will be determined by the treating physician.

  Up to 24 weeks

Study Arms (1)

radioiodide (I-)

EXPERIMENTAL

The Phase I portion will follow a 3+3 design with 4 dose levels (30, 60, 120, and 200 mCi) of I- treatment. The maximum tolerated dose (from Phase I) will be used in the Phase II efficacy assessment which will follow a Simon's optimal two-stage design.

Radiation: Radioiodide (131I-)

Interventions

Radioiodide (131I-) RADIATION

The Phase I portion will follow a 3+3 design with 4 dose levels (30, 60, 120, and 200 mCi) of I- treatment. The maximum tolerated dose (from Phase I) will be used in the Phase II efficacy assessment which will follow a Simon's optimal two-stage design.

radioiodide (I-)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed breast cancer with clinical and/or radiological evidence of measurable or evaluable metastatic disease by Response Evaluation in Solid Tumors (RECIST) 1.1.
• Life expectancy ≥12 weeks.
• Radiologic or clinical evidence of disease progression on prior hormonal and/or chemotherapy
• There is no restriction on the number of prior lines of therapy.
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of \< 2.
• Full recovery to Grade ≤ 2 from any prior side effects of prior therapy for cancer including radiation therapy, chemotherapy, and/or immunotherapy.
• Adequate bone marrow function defined as white blood cells (WBCs) ≥ 3.0 × 109/L, neutrophils ≥ 1.5 × 109/L, platelets ≥ 100 × 109/L.
• Adequate renal function defined as serum creatinine \< 1.5 mg/dL or creatinine clearance (GFR) \> 40 mL/min calculated using the following formula: GFR = 175 x Serum Cr-1.154 x age-0.203 x 0.742 (female) and x 1.212 (if patient is African American).
• Adequate liver function defined as AST, ALT ≤ 3 × upper limit of normal (UNL) in the absence of liver metastasis and ≤ 5 × UNL with liver metastases; bilirubin \< 1.5 × UNL; alkaline phosphatase ≤ 2.5 × UNL in the absence of liver metastasis and \< 5 × UNL in case of bone metastases.
• TSH, T3 and free T4 must be within normal range.
• The patient should not have had intravenous or intrathecal iodinated contrast agents (IVP, CT with contrast, myelogram, angiogram) for 4 weeks prior to screening to their 124I- PET/CT scans and/or 131I- treatment.
• Patients with treated brain metastases are eligible if the brain metastases have remained stable for more than 4 weeks after completing therapy to the brain.
• Normal urine or serum Beta-HCG in premenopausal women of childbearing potential
• Women of childbearing potential must agree to use effective contraception during the treatment period and for at least 6 months after the last dose of 124I- and/or 131I- as these agents interfere with radioactive iodide uptake
• Signed informed consent.

You may not qualify if:

• Concurrent anti-tumor treatment including radiation therapy, hormonal and chemotherapy.
• Patients with symptomatic cardiac disease such as coronary artery disease, congestive heart failure, or atrial fibrillation.
• Significant gastrointestinal abnormalities, including: ulcerative colitis, chronic diarrhea associated with intestinal malabsorption, Crohn's disease, and prior surgical procedures affecting absorption.
• Women who are nursing or pregnant.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Smilow Cancer Center

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Lajos Pusztai, M.D., D.Phil

  Yale University: Professor of Medicine, Section of Medical Oncology

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 7, 2016
• First Posted: December 9, 2016
• Study Start: December 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: August 22, 2018

Record last verified: 2018-08

Locations

US (1)