A Multiple-Dose Targeting Study of hu3S193 in Patients With Small Cell Lung Cancer
18 Years
N/A
Both
Lung Cancer
Trial Information
A Multiple-Dose Targeting Study of hu3S193 in Patients With Small Cell Lung Cancer
OBJECTIVES:
Primary
- Determine the targeting, tissue distribution, and pharmacokinetics of monoclonal
antibody Hu3S193 in patients with progressive small cell lung cancer.
Secondary
- Determine the immunogenicity of this drug in these patients.
- Determine tumor response in patients treated with this drug.
- Determine the safety of this drug in these patients.
OUTLINE: This is an open-label, pilot study.
Patients receive monoclonal antibody Hu3S193 (MOAB Hu3S193) IV over 30 minutes on day 1 of
weeks 1-4. Patients also receive indium In III MOAB Hu3S193 IV over 30 minutes on day 1 of
weeks 1 and 4 and then undergo gamma camera imaging. Treatment continues in the absence of
disease progression or unacceptable toxicity.
Patients are followed at 1 and 4 weeks, every 3 months for 1 year, and then every 6-12
months thereafter.
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed small cell lung cancer
- Progressive disease after 1-3 prior chemotherapy regimens
- Measurable disease
- At least 1 measurable lesion ≥ 2 cm that is not in a previously irradiated field
- Positive immunohistochemical staining for Lewis Y
- No uncontrolled brain or leptomeningeal metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 70-100% OR
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- WBC ≥ 3,500/mm^3
- Platelet count ≥ 150,000/mm^3
Hepatic
- Bilirubin ≤ 2.0 mg/dL
- INR ≤ 1.3
Renal
- Creatinine ≤ 2.0 mg/dL
Cardiovascular
- No clinically significant cardiac disease
- No New York Heart Association class III or IV cardiac disease
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Stool guaiac test negative
- No gastrointestinal bleed within the past 6 months
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior mouse monoclonal antibody
Chemotherapy
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy
Surgery
- Not specified
Other
- More than 4 weeks since prior participation in any other clinical trial involving
another investigational agent
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Lee M. Krug, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000365621
NCT ID:
NCT00084799
Start Date:
February 2004
Completion Date:
Related Keywords:
- Lung Cancer
- recurrent small cell lung cancer
- Lung Neoplasms
- Small Cell Lung Carcinoma
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
