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Head and Neck NeoplasmsPhase 1NCT02204033

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

A Phase 1 study testing 99mTc - labelled hMAb BIWA 4, 186 Re - labelled hMAb BIWA 4 and unlabelled hMAb BIWA 4 - low dose in people with Head and Neck Neoplasms, run by Boehringer Ingelheim.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Head and Neck Neoplasms
What is being tested?
99mTc - labelled hMAb BIWA 4, 186 Re - labelled hMAb BIWA 4 and unlabelled hMAb BIWA 4 - low dose
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
No sites listed yet
Study dates
Mar 1999to Jun 2001
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

Official title: 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.

Being tested
99mTc - labelled hMAb BIWA 4, 186 Re - labelled hMAb BIWA 4, unlabelled hMAb BIWA 4 - low dose, unlabelled hMAb BIWA 4 - medium dose, unlabelled hMAb BIWA 4 - high dose
Medical subject headings
Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 99mTc - labelled hMAb BIWA 4Drug

  • 186 Re - labelled hMAb BIWA 4Drug

  • unlabelled hMAb BIWA 4 - low doseDrug

  • unlabelled hMAb BIWA 4 - medium doseDrug

  • unlabelled hMAb BIWA 4 - high doseDrug

Study groups in NCT02204033
Study groupRoleWhat they receive
99mTc - labelled hMAb BIWA 4 - low doseExperimentalNot described
Receives: Drug: 99mTc - labelled hMAb BIWA 4; Drug: unlabelled hMAb BIWA 4 - low dose
99mTc - labelled hMAb BIWA 4 - medium doseExperimentalNot described
Receives: Drug: 99mTc - labelled hMAb BIWA 4; Drug: unlabelled hMAb BIWA 4 - medium dose
99mTc - labelled hMAb BIWA 4 - high doseExperimentalNot described
Receives: Drug: 99mTc - labelled hMAb BIWA 4; Drug: unlabelled hMAb BIWA 4 - high dose
186 Re - labelled hMAb BIWA 4 - escalating doseExperimentalNot described
Receives: Drug: 186 Re - labelled hMAb BIWA 4

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with adverse events

    Measured: up to 10 weeks

  2. Presence of human-anti-human-antibody (HAHA)

    Measured: after 144 hours post infusion

  3. Number of patients with clinically significant changes in vital signs

    Measured: up to 6 weeks after infusion

  4. Biodistribution of 99mTC-labelled hMAb BIWA 4 in tumour and normal tissue samples - Biopsy (Part A)

    uptake expressed as percentage of the injected dose per kg tissue (%ID/kg)

    Measured: at 48 h after infusion

  5. Immunoscintigraphic imaging evaluation (Parts A + B)

    Measured: up to 21 hours after infusion

  6. AUC0-∞ (Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

    Measured: up to 336 hours after infusion

  7. Cmax (Maximum measured concentration of the analyte in plasma)

    Measured: up to 336 hours after infusion

  8. tmax (Time from dosing to the maximum concentration of the analyte in plasma)

    Measured: up to 336 hours after infusion

  9. t½ (Terminal half-life of the analyte in plasma)

    Measured: up to 336 hours after infusion

  10. Vz (Apparent volume of distribution during the terminal phase)

    Measured: up to 336 hours after infusion

  11. Vss (Apparent volume of distribution under steady-state conditions)

    Measured: up to 336 hours after infusion

  12. CL (Total body clearance)

    Measured: up to 336 hours after infusion

  13. MRT (Mean residence time)

    Measured: up to 336 hours after infusion

  14. Cumulative urinary excretion of radioactivity over time

    Measured: up to 96 hours after infusion

  15. Number of patients with abnormal changes in laboratory parameters

    Measured: up to 6 weeks after infusion

  16. Occurence of dose limiting toxicities (DLT)

    Measured: up to 144 hours post infusion

  17. Uptake of 99mTC-labelled hMAb BIWA 4 in tumour and normal tissue samples (Part A)

    Assessment of biodistribution by radioimmunoscintigraphy expressed as low, medium or high

    Measured: up to 6 weeks after infusion

  18. Actual organ uptake of 99mTC-labelled hMAb BIWA 4

    expressed as % I.D. (injected dose)

    Measured: at 21 h after infusion

Secondary outcomes (2)

  1. Tumour response according to response criteria of the World Health Organisation (WHO)

    assessed by Computer Tomography (CT) and/or by Magnet resonance imaging (MRI) and/or bone scintigraphy and/or by physical examination

    Measured: up to 144 hours after infusion

  2. Maximum tolerated radiation dose of 186Re-labelled hMAb BIWA 4

    Measured: up to 144 hours after infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2014 (estimated)
  2. Study startMar 1999
  3. Primary completionJun 2001

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02204033
Sponsor's protocol ID
1170.1
Status last verified
Jul 2014
First submitted
29 Jul 2014
Last updated
30 Jul 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 99mTc - labelled hMAb BIWA 4, 186 Re - labelled hMAb BIWA 4 and unlabelled hMAb BIWA 4 - low dose in people with Head and Neck Neoplasms, run by Boehringer Ingelheim.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with adverse events (time frame: up to 10 weeks). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02204033.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2014.

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