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

NCT02199886 | Terminated Phase 1

• 1 other identifier: 1152.3
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lung Neoplasms

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Concentration of human anti-human antibodies (HAHA)

  up to day 30

Study Arms (1)

BIBH 1

EXPERIMENTAL

dose escalation: 0.5, 2, 10 or 20mg/m\*\*2, 7 days prior to surgery

Drug: BIBH 1

Interventions

BIBH 1 DRUG

labeled with eight to ten millicurie of 131I

BIBH 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2014
• First Posted: July 25, 2014
• Study Start: July 1, 1998
• Primary Completion: December 1, 2001
• Last Updated: July 25, 2014

Record last verified: 2014-07