Monoclonal Antibody Therapy in Treating Patients With Progressive Small Cell Lung Cancer - Full Text View

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00084799

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	Drug: monoclonal antibody Hu3S193	Phase I

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Multiple-Dose Targeting Study of hu3S193 in Patients With Small Cell Lung Cancer

Further study details as provided by National Cancer Institute (NCI):

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00084799

Locations

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

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

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

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000365621, MSKCC-04012, LUDWIG-LUD2002-015
Study First Received:	June 10, 2004
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00084799
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent small cell lung cancer

Study placed in the following topic categories:

Thoracic Neoplasms
Carcinoma, Neuroendocrine
Recurrence
Carcinoma
Neuroendocrine Tumors
Antibodies, Monoclonal
Carcinoma, Small Cell
Neuroectodermal Tumors
Antibodies

Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Adenocarcinoma
Immunoglobulins
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site

Immunologic Factors
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009