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

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02199886
• Other study ID #: 1152.3
• Status: Terminated
• Phase: Phase 1
• First received: July 24, 2014
• Last updated: July 24, 2014
• Start date: July 1998

Study information

• Verified date: July 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• 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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

Intervention

Drug:
• BIBH 1
labeled with eight to ten millicurie of 131I

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

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

External Links

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