Status:
TERMINATED
Dose-escalation Study of BIBH 1 in Patients With Non-small Cell Lung Cancer Scheduled for Surgical Resection
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Lung Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 n...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT02199886
Start Date
July 1 1998
Last Update
July 25 2014
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