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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00084799
First received: June 10, 2004
Last updated: February 6, 2009
Last verified: April 2006
  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:


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
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
Memorial Sloan-Kettering Cancer Center
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

Additional Information:
No publications provided

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: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014