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

NCT ID: NCT02204033

Last Updated: 2014-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-03-31

Brief 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 radiation dose of 186 Re-labelled hMAb BIWA 4 and to propose a safety dose for phase II development.

Conditions

Head and Neck Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

99mTc - labelled hMAb BIWA 4 - low dose

Group Type: EXPERIMENTAL

99mTc - labelled hMAb BIWA 4

Intervention Type: DRUG

unlabelled hMAb BIWA 4 - low dose

Intervention Type: DRUG

99mTc - labelled hMAb BIWA 4 - medium dose

Group Type: EXPERIMENTAL

99mTc - labelled hMAb BIWA 4

Intervention Type: DRUG

unlabelled hMAb BIWA 4 - medium dose

Intervention Type: DRUG

99mTc - labelled hMAb BIWA 4 - high dose

Group Type: EXPERIMENTAL

99mTc - labelled hMAb BIWA 4

Intervention Type: DRUG

unlabelled hMAb BIWA 4 - high dose

Intervention Type: DRUG

186 Re - labelled hMAb BIWA 4 - escalating dose

Group Type: EXPERIMENTAL

186 Re - labelled hMAb BIWA 4

Intervention Type: DRUG

Interventions

99mTc - labelled hMAb BIWA 4

Intervention Type: DRUG

186 Re - labelled hMAb BIWA 4

Intervention Type: DRUG

unlabelled hMAb BIWA 4 - low dose

Intervention Type: DRUG

unlabelled hMAb BIWA 4 - medium dose

Intervention Type: DRUG

unlabelled hMAb BIWA 4 - high dose

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1170.1

Identifier Type: -

Identifier Source: org_study_id