Monoclonal Antibody Therapy in Treating Patients With Progressive Small Cell Lung Cancer

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Lung Cancer	Biological: monoclonal antibody Hu3S193	Phase 1

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Masking:	None (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

Arms and Interventions

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Outcome Measures

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Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021

Sponsors and Collaborators

Ludwig Institute for Cancer Research

National Cancer Institute (NCI)

Investigators

Principal Investigator:	Lee M. Krug, MD	Memorial Sloan Kettering Cancer Center
Principal Investigator:	Chaitanya R. Divgi, MD	Memorial Sloan Kettering Cancer Center

More Information

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ClinicalTrials.gov Identifier:	NCT00084799 History of Changes
Other Study ID Numbers:	CDR0000365621; MSKCC-04012; LUDWIG-LUD2002-015
First Posted:	June 11, 2004
Last Update Posted:	June 16, 2015
Last Verified:	June 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