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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim

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.