Single Dose Escalation Study of 131I-Sibrotuzumab in Patients With Advanced or Metastatic Non-small Cell Lung Cancer

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

A Phase I Single Dose Escalation Study of 131I-Sibrotuzumab in Patients With Advanced or Metastatic Non-small Cell Lung Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02209727
• Other study ID #: 1152.6
• Status: Terminated
• Phase: Phase 1
• First received: August 5, 2014
• Last updated: August 5, 2014
• Start date: December 2000

Study information

• Verified date: August 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 determine the maximum tolerated dose (MTD) and safety profile of a single-dose administration of sibrotuzumab (50 mg) conjugated to an increasing dose of 131 I isotope.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. primary completion date: June 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Evidence of advanced, non-resectable, and/or metastatic non-small cell lung cancer and at least one previous conventional treatment for advanced disease

• Eastern cooperative Oncology Group (ECOG) performance status of 0 or 1

• Measurable or evaluable disease, determined by World Health Organization (WHO) criteria using standard imaging modalities, including ultrasound, X-ray, CT and/or Magnetic Resonance Imaging (MRI). Bone scans and/or antibody scans are not to be used to determine the extent of the disease

• Expected survival of = 16 weeks

• At least 18 years of age

• Platelet count = 100 x 10**9/L

• Absolute neutrophil count = 2.0 x 10**9/L

• Aspartate aminotransferase (AST) = 3 x upper limit of normal or < 5 x upper limit of normal if liver metastases are present

• Total bilirubin = 2mg/dL

• Serum creatinine = 2mg/dL

• Ability to provide written informed consent

Exclusion Criteria:

• Known brain metastases

• Exposure to an investigational agent within 30 days prior to receiving the scout dose

• Incomplete recovery from surgery or incomplete healing of an incision site or evidence of infection

• Treatment with cytotoxic chemotherapy, radiation or immunosuppressive therapy within the 30 days (42 days for nitrosoureas and/or mitomycin C) of the scout infusion. Patients using inhaled corticosteroids are considered eligible for enrollment

• Serious illnesses, i.e., active infections requiring antibiotics, bleeding disorders or other serious illnesses precluding the use of either 131I or sibrotuzumab

• Women who are breast-feeding or pregnant

• Men and women who were sexually active and are unwilling to utilize a medically acceptable method of contraception

• Hypertrophic skin disease or autoimmune disease that possibly involves over-expression of fibroblast activation protein (FAP), which can be targeted by the antibody. These diseases include active inflammatory arthritis, cirrhosis, and keloids

• Unstable angina pectoris. Patients prescribed medication to control their angina pectoris must have been on a fixed dose for at least 1 month prior to screening to be eligible for trial enrollment

• Myocardial infarction within 3 months prior to screening

• New York Heart Association (NYHA) Heart failure stage III or IV, or a left ventricular ejection fraction of = 40 %

• Impaired lung function, measured by a decrease in forced expiratory volume at one second (FEV1) to less than 50 % of the predicted normal value

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• 131I-Sibrotuzumab
50 mg Sibrotuzumab conjugated with 131I

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of the dose limiting toxicity (DLT)		up to 12 weeks	No
Primary	Determination of the maximum tolerated dose (MTD)	MTD is defined as the highest dose below which two patients experience DLT	up to 12 weeks	No
Primary	Occurrence of toxicity	graded according to the Common Toxicity Criteria (CTC)	up to 12 weeks	No
Secondary	Maximum tumor response using the World Health Organisation (WHO) Disease Response Criteria		8 weeks after therapeutic infusion	No

External Links

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