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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2003 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006347
First received: October 4, 2000
Last updated: February 28, 2009
Last verified: April 2003
  Purpose

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 Intervention Phase
Lung Cancer
Radiation: indium In 111 monoclonal antibody MN-14
Radiation: yttrium Y 90 monoclonal antibody MN-14
Phase 1

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


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

Study Start Date: August 2000
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 70-100%
  • ECOG 0-2

Life expectancy:

  • At least 3 months

Hematopoietic:

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

Hepatic:

  • 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

Renal:

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

Cardiovascular:

  • Ejection fraction at least 50%

Pulmonary:

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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

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

Chemotherapy:

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

Endocrine therapy:

  • Not specified

Radiotherapy:

  • 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

Surgery:

  • At least 4 weeks since prior major surgery
  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: NCT00006347

Locations
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
Investigators
Study Chair: Jack D. Burton, MD Garden State Cancer Center at the Center for Molecular Medicine and Immunology
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00006347     History of Changes
Other Study ID Numbers: CDR0000068199, CMMI-C-057A-99, NCI-H00-0064
Study First Received: October 4, 2000
Last Updated: February 28, 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
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Antibodies
Antibodies, Monoclonal
Immunoglobulins
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014