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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00084799

First Posted: June 11, 2004

Last Update Posted: June 16, 2015

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborator:

National Cancer Institute (NCI)

Information provided by:

Ludwig Institute for Cancer Research

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: None (Open Label) Primary Purpose: Treatment
Official Title:	A Multiple-Dose Targeting Study of hu3S193 in Patients With Small Cell Lung Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: lung cancer

MedlinePlus related topics: Lung Cancer

U.S. FDA Resources

Further study details as provided by Ludwig Institute for Cancer Research:


Study Start Date:	February 2004

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.

Eligibility

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00084799

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


ClinicalTrials.gov Identifier:	NCT00084799 History of Changes
Other Study ID Numbers:	CDR0000365621 MSKCC-04012 LUDWIG-LUD2002-015
First Submitted:	June 10, 2004
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

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