A PHASE 0 SINGLE MICRODOSE STUDY TO EVALUATE THE PHARMACOKINETICS/-DYNAMICS AND SPECIFIC TUMORTARGETING OF 124-I-F16SIP IN HEAD AND NECK CANCER PATIENTS

Completed

• Conditions: head and neck cancer; head and neck squamous cell carcinoma; 10038666

• Registration Number: NL-OMON32737
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 5

Inclusion Criteria

1. Patients with previously untreated head and neck cancer scheduled for surgery
2. Histologically/cytologically confirmed diagnosis of cancer.

Exclusion Criteria

1. 1. Chemotherapy, radiation, hormone therapy (with the exception of a gradual titration of LHRH agonists) or immunotherapy or participation in any investigational drug study within 4 weeks of study entry (6 weeks in case of prior nitroureas chemotherapy).
2. Prior radiation dose > 30% of bone marrow volume.
3. Presence of cirrhosis or active hepatitis.
4. Presence of serious cardiac (congestive heart failure, heart insufficiency > grade II NYHA, angina pectoris, myocardial infarction within one year prior to study entry, uncontrolled hypertension or arrhythmia), neurological or psychiatric disorders.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The tumor targeting performance of the human radiolabeled antibody 124I-F16SIP.<br /><br>Pharmacokinetics/-dynamics of 124I-F16SIP, and its uptake in tumor and normal<br /><br>tissues as obtained from the surgical specimen.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Dosimetric parameters for tumor, bone marrow and normal organs.</p><br>