Dose-escalation Study of BIBH 1 in Patients With Non-small Cell Lung Cancer Scheduled for Surgical Resection

NCT ID: NCT02199886

Last Updated: 2014-07-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-07-31

Brief Summary

Study to assess the toxicity, pharmacokinetics, biodistribution and imaging characteristics associated with increasing doses of 131I-BIBH 1, to compare the uptake of 131I-BIBH 1 in tumour to that of normal tissue in patients with non-small cell lung cancer and to measure human anti-human antibody (HAHA) concentrations.

Conditions

Lung Neoplasms

Study Design

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

Study Groups

BIBH 1

dose escalation: 0.5, 2, 10 or 20mg/m\*\*2, 7 days prior to surgery

Group Type: EXPERIMENTAL

BIBH 1

Intervention Type: DRUG

labeled with eight to ten millicurie of 131I

Interventions

BIBH 1

labeled with eight to ten millicurie of 131I

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histologically confirmed primary or secondary advanced non-small cell lung cancer
• Eligible for a lung biopsy or scheduled for surgery that would provide biopsy material
• Karnofsky performance status of ≥ 70
• Expected survival of ≥ 3 months
• Greater than or equal to 18 years of age
• Absolute granulocyte count ≥ 2.5 x 10**9/L
• Lymphocyte count > 0.7 x 10**9/L
• Platelet count ≥ 100 x 10**9/L
• Serum Creatinine ≤ 2.0 mg/dl (0.20 mmol/L)
• Alanine aminotransferase/aspartate aminotransferase (ALT/AST) ≤ 3x upper limit of normal
• Total bilirubin < 2 mg/dl or 34µmol (SI unit equivalent)
• Ability to provide written informed consent

Exclusion Criteria

• Active metastatic disease to the central nervous system, exhibited by new or enlarging lesions on CT or MRI scan or within 3 months of treatment (i.e., surgery or radiotherapy) for brain metastases
• Exposure to an investigational agent within four weeks of the BIBH 1 infusion
• Patients that are not fully recovered from surgery. Because of the potential binding of BIBH 1 to healing scars, patients with incomplete healing at an incision site, as evidenced by incomplete granulation, infection or localized edema are excluded
• Chemotherapy or immunotherapy within four weeks preceding entry (six weeks for nitrsoureas and/or mitomycin-C.)
• Previous administration of a murine, chimeric or humanised measurement and/or antibody fragment
• Serious illness: e.g., active infections requiring antibiotics, bleeding disorders or diseases considered by the investigator to have potential for interfering with obtaining accurate results from this study
• Women who are breast-feeding or pregnant
• Men and women of childbearing potential who are unwilling to utilize a medically acceptable method of contraception
• Previous participation in this study
• Patients who have autoimmune disease or hypertopic skin conditions that possibly over-express Fibroblast Activation Protein and may be targeted by the antibody. These diseases include active inflammatory arthritis, cirrhosis and keloids.
• Patients with unstable angina pectoris. Patients prescribed medication to control their angina pectoris must be on a fixed dose for at least 1 month prior to screening to be eligible for the trial.
• Patients who experienced a myocardial infarction within 3 months of Screening.

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

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1152.3

Identifier Type: -

Identifier Source: org_study_id