Lung Neoplasms Clinical Trial
Official title:
A Phase I Single Dose-escalation Study of BIBH 1 in Patients With Non-small Cell Lung Cancer Scheduled for Surgical Resection
NCT number | NCT02199886 |
Other study ID # | 1152.3 |
Secondary ID | |
Status | Terminated |
Phase | Phase 1 |
First received | July 24, 2014 |
Last updated | July 24, 2014 |
Start date | July 1998 |
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.
Status | Terminated |
Enrollment | 6 |
Est. completion date | |
Est. primary completion date | December 2001 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Boehringer Ingelheim |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Occurrence of dose-limiting toxicities as defined by Common toxicity criteria (CTC) | up to 30 days | No | |
Primary | Number of patients with abnormal biodistribution for 131I BIBH 1 | up to day 30 | No | |
Primary | Tumor absorbed dose of 131I BIBH 1 | week 2 | No | |
Secondary | Concentration of human anti-human antibodies (HAHA) | up to day 30 | No |
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