Dose Escalation Study With 99mTC - or 186 Re-labelled Humanised Monoclonal Antibody (hMAb) BIWA 4 in Patients With Head and Neck Cancer

July 29, 2014 updated by: Boehringer Ingelheim

A Phase I Dose Escalation Study With 99mTC - or 186 Re-labelled Humanised Monoclonal Antibody BIWA 4, in Patients With Head and Neck Cancer

The general aim of the present study was to assess the safety and tolerability of intravenously administered Technetium 99m (99mTc) and Rhenium-186 radionuclide (186 Re) -labelled hMAb BIWA 4, to confirm preferential accumulation in the tumour of 99mTc - labelled hMAb BIWA 4, to determine the maximum tolerated radiation dose of 186 Re-labelled hMAb BIWA 4 and to propose a safety dose for phase II development.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with histological confirmation of squamous cell carcinoma in the head and neck
  • Patients destined for surgery by means of neck dissection (Part A) or :
  • Patients with either local and/or regional recurrent disease for which curative treatment options were not available or distant metastases. The tumor deposits had to be measurable either clinically or by one or more radiological technique (s) (CT, MRI, bone scintigraphy). Because RIT was expected to be more effective in smaller size tumor deposits, patients with lesions measuring > 3 cm in greatest dimension were preferred (Part B)
  • Patients over 18 years of age
  • Patients younger than 80 years of age
  • Patients who had given 'written informed consent'
  • Patients with a life expectancy of at least 3 months
  • Patients with a good performance status: Karnofsky > 60

Exclusion Criteria:

  • Life-threatening infection, allergic diathesis, organ failure (bilirubin > 30µmol/l and/or creatinine > 150 µmol/l) or evidence of a recent myocardial infarction on ECG or unstable angina pectoris

  • Pre-menopausal women (last menstruation <= 1 year prior to study start)

    • Not surgically sterile (hysterectomy, tubal ligation) and
    • Not practicing acceptable means of birth control, (nor not planned to be continued throughout the study). Acceptable methods of birth control include oral, implantable or injectable contraceptives
  • Women with a positive serum pregnancy test at baseline
  • Chemotherapy or radiotherapy within 4 weeks before inclusion in the study
  • White blood cell count < 3000/mm³, granulocyte count < 1500/mm³ or platelet count < 100000/mm³
  • Hematological disorders, congestive heart failure, bronchial asthma, alimentary or contact allergy, severe atopy or allergy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 99mTc - labelled hMAb BIWA 4 - low dose
Drug: 99mTc - labelled hMAb BIWA 4
Drug: unlabelled hMAb BIWA 4 - low dose
Experimental: 99mTc - labelled hMAb BIWA 4 - medium dose
Drug: 99mTc - labelled hMAb BIWA 4
Drug: unlabelled hMAb BIWA 4 - medium dose
Experimental: 99mTc - labelled hMAb BIWA 4 - high dose
Drug: 99mTc - labelled hMAb BIWA 4
Drug: unlabelled hMAb BIWA 4 - high dose
Experimental: 186 Re - labelled hMAb BIWA 4 - escalating dose
Drug: 186 Re - labelled hMAb BIWA 4

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of patients with adverse events
Time Frame: up to 10 weeks
up to 10 weeks
Presence of human-anti-human-antibody (HAHA)
Time Frame: after 144 hours post infusion
after 144 hours post infusion
Number of patients with clinically significant changes in vital signs
Time Frame: up to 6 weeks after infusion
up to 6 weeks after infusion
Biodistribution of 99mTC-labelled hMAb BIWA 4 in tumour and normal tissue samples - Biopsy (Part A)
Time Frame: at 48 h after infusion
uptake expressed as percentage of the injected dose per kg tissue (%ID/kg)
at 48 h after infusion
Immunoscintigraphic imaging evaluation (Parts A + B)
Time Frame: up to 21 hours after infusion
up to 21 hours after infusion
AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time Frame: up to 336 hours after infusion
up to 336 hours after infusion
Cmax (Maximum measured concentration of the analyte in plasma)
Time Frame: up to 336 hours after infusion
up to 336 hours after infusion
tmax (Time from dosing to the maximum concentration of the analyte in plasma)
Time Frame: up to 336 hours after infusion
up to 336 hours after infusion
t½ (Terminal half-life of the analyte in plasma)
Time Frame: up to 336 hours after infusion
up to 336 hours after infusion
Vz (Apparent volume of distribution during the terminal phase)
Time Frame: up to 336 hours after infusion
up to 336 hours after infusion
Vss (Apparent volume of distribution under steady-state conditions)
Time Frame: up to 336 hours after infusion
up to 336 hours after infusion
CL (Total body clearance)
Time Frame: up to 336 hours after infusion
up to 336 hours after infusion
MRT (Mean residence time)
Time Frame: up to 336 hours after infusion
up to 336 hours after infusion
Cumulative urinary excretion of radioactivity over time
Time Frame: up to 96 hours after infusion
up to 96 hours after infusion
Number of patients with abnormal changes in laboratory parameters
Time Frame: up to 6 weeks after infusion
up to 6 weeks after infusion
Occurence of dose limiting toxicities (DLT)
Time Frame: up to 144 hours post infusion
up to 144 hours post infusion
Uptake of 99mTC-labelled hMAb BIWA 4 in tumour and normal tissue samples (Part A)
Time Frame: up to 6 weeks after infusion
Assessment of biodistribution by radioimmunoscintigraphy expressed as low, medium or high
up to 6 weeks after infusion
Actual organ uptake of 99mTC-labelled hMAb BIWA 4
Time Frame: at 21 h after infusion
expressed as % I.D. (injected dose)
at 21 h after infusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Tumour response according to response criteria of the World Health Organisation (WHO)
Time Frame: up to 144 hours after infusion
assessed by Computer Tomography (CT) and/or by Magnet resonance imaging (MRI) and/or bone scintigraphy and/or by physical examination
up to 144 hours after infusion
Maximum tolerated radiation dose of 186Re-labelled hMAb BIWA 4
Time Frame: up to 144 hours after infusion
up to 144 hours after infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 1999

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2001

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1170.1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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