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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Ludwig Institute for Cancer Research
ClinicalTrials.gov Identifier:
NCT00084799
First received: June 10, 2004
Last updated: June 15, 2015
Last verified: June 2015
History of Changes
  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

Resource links provided by NLM:

MedlinePlus related topics: Cancer 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
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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 
Study First Received: June 10, 2004
Last Updated: June 15, 2015
Health Authority: United States: Food and Drug Administration

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 September 28, 2016