Lung Neoplasms
Conditions
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.
Interventions
DRUGBIBH 1
labeled with eight to ten millicurie of 131I
Sponsors
Boehringer Ingelheim
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of dose-limiting toxicities as defined by Common toxicity criteria (CTC) | up to 30 days |
| Number of patients with abnormal biodistribution for 131I BIBH 1 | up to day 30 |
| Tumor absorbed dose of 131I BIBH 1 | week 2 |
Secondary
| Measure | Time frame |
|---|---|
| Concentration of human anti-human antibodies (HAHA) | up to day 30 |
Outcome results
None listed