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Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00006347
Recruitment Status : Unknown
Verified April 2003 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : March 3, 2009
Information provided by:

Study Description
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: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have relapsed or refractory small cell lung cancer.

Condition or disease Intervention/treatment Phase
Lung Cancer Radiation: indium In 111 monoclonal antibody MN-14 Radiation: yttrium Y 90 monoclonal antibody MN-14 Phase 1

Detailed Description:


  • Determine the dose limiting toxicity and maximum tolerated dose of yttrium Y 90 anti-CEA monoclonal antibody MN-14 in patients with relapsed or refractory small cell lung cancer.
  • Determine the dosimetric and pharmacokinetic properties of this treatment regimen in the blood, normal organs, and tumors of these patients.
  • Determine the stability and complexation with circulating carcinoembryonic antigen of this radioantibody in the plasma of these patients.
  • Determine the antibody response of these patients treated with this regimen.
  • Determine the antitumor effects of this treatment regimen in these patients.

OUTLINE: This is a dose escalation study of yttrium Y 90 anti-CEA monoclonal antibody MN-14 (90Y-hMN-14). Patients are stratified according to prior radiotherapy (yes vs no).

Patients undergo pretherapy imaging with indium In 111 anti-CEA monoclonal antibody MN-14 IV over 30-40 minutes on day -7 or -6 followed by external scintigraphy on days -7 or -6 to 0.

Patients who show positive localization of at least one documented tumor site receive 90Y-hMN-14 IV over 30-40 minutes on day 0.

Cohorts of 3-6 patients receive escalating doses of 90Y-hMN-14 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose limiting toxicity.

Patients are followed at 2, 4, 8, and 12 weeks; every 3 months for 2 years; and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 10-14 months.

Study Design

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase I Non-Myeloablative Trial With 90Y-Humanized MN-14 (Anti-CEA) Antibody for Relapsed or Refractory Small Cell Lung Cancer (SCLC)
Study Start Date : August 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

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


  • Histologically or cytologically confirmed small cell lung cancer (SCLC)

    • Must have received at least one prior course of standard chemotherapy and, if indicated, up to 6,900 cGy of thoracic radiotherapy
    • Patients who received prior radiotherapy must show evidence of progressive disease
    • Patients who received no prior radiotherapy to the primary tumor must show evidence of stable or progressive disease
  • Measurable disease
  • Must have evidence of carcinoembryonic antigen (CEA) production or expression documented by one of the following:

    • Serum CEA at least 10 ng/mL
    • Positive immunohistology of either the primary tumor or a metastasis with CEA specific monoclonal antibody
  • Must have unilateral bone marrow biopsy with less than 25% tumor involvement
  • No known, active brain metastases



  • 18 and over

Performance status:

  • Karnofsky 70-100%
  • ECOG 0-2

Life expectancy:

  • At least 3 months


  • WBC at least 3,000/mm^3
  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 2 mg/dL
  • AST no greater than 2 times upper limit of normal (ULN)
  • No hepatitis B or C
  • No other serious liver abnormality


  • Creatinine no greater than 1.5 times ULN
  • No urinary incontinence


  • Ejection fraction at least 50%


  • FEV_1 and FVC at least 60%
  • DLCO at least 50% predicted


  • No severe anorexia, nausea, or vomiting
  • No other significant medical problems
  • No prisoners
  • No reactivity to humanized MN-14 (in patients with prior exposure to chimeric or humanized antibody)
  • HIV negative
  • No active HIV-related disease
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 3 months following study participation


Biologic therapy:

  • See Chemotherapy
  • No concurrent growth factors (e.g., filgrastim [G-CSF])


  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy
  • No prior high dose chemotherapy with stem cell transplantation

Endocrine therapy:

  • Not specified


  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy
  • Prior radiotherapy to less than 30% of red marrow (including standard chest x-ray for limited stage SCLC) allowed


  • At least 4 weeks since prior major surgery
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): NCT00006347

United States, New Jersey
Garden State Cancer Center
Belleville, New Jersey, United States, 07109
Sponsors and Collaborators
Garden State Cancer Center at the Center for Molecular Medicine and Immunology
National Cancer Institute (NCI)
Study Chair: Jack D. Burton, MD Garden State Cancer Center at the Center for Molecular Medicine and Immunology
More Information

ClinicalTrials.gov Identifier: NCT00006347     History of Changes
Other Study ID Numbers: CDR0000068199
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: March 3, 2009
Last Verified: April 2003

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
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs