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Phase I Non-Myeloablative Trial With 90Y-Humanized MN-14 (Anti-CEA) Antibody for Relapsed or Refractory Advanced Non-Small Cell Lung Cancer (NSCLC)

Phase 1
18 Years
Open (Enrolling)
Lung Cancer

Thank you

Trial Information

Phase I Non-Myeloablative Trial With 90Y-Humanized MN-14 (Anti-CEA) Antibody for Relapsed or Refractory Advanced Non-Small Cell Lung Cancer (NSCLC)

OBJECTIVES: I. 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 non-small cell
lung cancer. II. Determine the dosimetric and pharmacokinetic properties of this treatment
regimen in the blood, normal organs, and tumors of these patients. III. Determine the
stability and complexation with circulating carcinoembryonic antigen of this radioantibody
in the plasma of these patients. IV. Determine the antibody response of these patients with
this treatment regimen. V. 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 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 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.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung
cancer Adenocarcinoma, squamous large cell, or mixed cell histology Patients with
nonadenocarcinomatous 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 received at least one prior regimen of standard chemotherapy
and, if indicated, no greater than 6,900 cGy thoracic radiotherapy Patients with stage
IIIA/B unresectable disease who received prior radiotherapy must show evidence of
progressive disease (greater than 25% increase in primary tumor or appearance of new
lesions) Patients with stage IIIB or IV disease who received no prior radiotherapy to the
primary or index lesion must show evidence of stable or progressive disease by CT scans at
least 4 weeks apart Less than 25% tumor involvement in bone marrow No known, active brain

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/mm3 Granulocyte count
at least 1,500/mm3 Platelet count at least 100,000/mm3 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% by MUGA Pulmonary: FEV1 at
least 60% DLCO at least 50% 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 Not pregnant or
nursing Negative pregnancy test Fertile patients must use effective contraception during
and for at least 3 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior stem cell transplantation after
high-dose chemotherapy No concurrent growth factors Chemotherapy: See Disease
Characteristics See Biologic At least 4 weeks since prior chemotherapy Endocrine therapy:
Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior
radiotherapy Prior radiotherapy to less than 30% of red marrow allowed Surgery: At least 4
weeks since prior major surgery

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Jack D. Burton, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Garden State Cancer Center at the Center for Molecular Medicine and Immunology


United States: Federal Government

Study ID:




Start Date:

August 2000

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • squamous cell lung cancer
  • large cell lung cancer
  • adenocarcinoma of the lung
  • adenosquamous cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Garden State Cancer Center Belleville, New Jersey  07103