To evaluate the tumor targeting performance of the human radiolabeled antibody 124I-F16SIP.To investigate pharmacokinetics/-dynamics of 124I-F16SIP, and to assess its uptake in tumor and normal tissues as obtained from the surgical specimen.
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The tumor targeting performance of the human radiolabeled antibody 124I-F16SIP.
Pharmacokinetics/-dynamics of 124I-F16SIP, and its uptake in tumor and normal
tissues as obtained from the surgical specimen.
Secondary outcome
Dosimetric parameters for tumor, bone marrow and normal organs.
Background summary
The F16SIP is a fully human antibody fragment, capable of preferential
localization around tumor blood vessels while sparing normal tissues. The
formation of new blood vessels is a rare event in the adult (exception made for
the female reproductive cycle), but is a pathological feature of most
aggressive types of cancer. The study aims at determining the
pharmacokinetics/-dynamics and specific tumor targeting properties of the F16
antibody in SIP format, labeled with the radionuclide 124I, in head and neck
cancer patients.
An efficient accumulation of 124I-F16SIP on the tumor lesions may provide and
incentive for both patient and clinical center to consider future therapeutic
strategies on the patient, based on F16 derivatives (e.g., F16-IL2 or
131I-F16SIP).
Study objective
To evaluate the tumor targeting performance of the human radiolabeled antibody
124I-F16SIP.
To investigate pharmacokinetics/-dynamics of 124I-F16SIP, and to assess its
uptake in tumor and normal tissues as obtained from the surgical specimen.
Study design
This is a phase 0 single microdose study of the tumor targeting human
124I-F16SIP monoclonal antibody, performed according to EMEA guideline
CPMP/SWP/2599/02/Rev1.
It is a uncontrolled, open-label study in one clinical center. 5 head and neck
cancer patients will be enrolled.
Single dose of 2 mg 124I-F16SIP labelled with up to 2 mCi (74 MBq) will be
administered i.v. to consenting patients. Target localization will be analyzed
by 3 PET/CT scans. Patients will be operated 7/8 days after infusion and the
uptake of 124I-F16SIP in tumor and normal tissues present in the surgical
specimen will be measured. The safety and tolerability of 124I-F16SIP will be
assessed with laboratory tests, vital signs measurement and recoding of adverse
events. Furthermore, the dosimetric parameters for the bone marrow will be
investigated.
Intervention
Administration of a single injection of 2 mg 124I-F16SIP, i.v.
Study burden and risks
Patients are exposed to radioactivity, but this will be very low because of the
low amount of radioactivity that will be used.
No adverse events are expected from the use of 124I-F16SIP.
De Boelelaan 1117
1081 HV
NL
De Boelelaan 1117
1081 HV
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-016036-12-NL |
| CCMO | NL29836.029.09 |