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Monoclonal Antibody Therapy in Treating Patients With Progressive Small Cell Lung Cancer
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Purpose
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: This phase I trial is studying the side effects of monoclonal antibody therapy in treating patients with progressive small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
| Lung Cancer | Biological: monoclonal antibody Hu3S193 | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multiple-Dose Targeting Study of hu3S193 in Patients With Small Cell Lung Cancer |
| Study Start Date: | February 2004 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00084799
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Principal Investigator: | Lee M. Krug, MD | Memorial Sloan Kettering Cancer Center |
| Principal Investigator: | Chaitanya R. Divgi, MD | Memorial Sloan Kettering Cancer Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00084799 History of Changes |
| Other Study ID Numbers: |
CDR0000365621 MSKCC-04012 LUDWIG-LUD2002-015 |
| Study First Received: | June 10, 2004 |
| Last Updated: | June 15, 2015 |
Keywords provided by Ludwig Institute for Cancer Research:
|
recurrent small cell lung cancer |
Additional relevant MeSH terms:
|
Lung Neoplasms Small Cell Lung Carcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Carcinoma, Bronchogenic Bronchial Neoplasms Antibodies Immunoglobulins Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 28, 2017