Know Cancer

forgot password

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

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 Small Cell Lung Cancer (SCLC)


- 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

Inclusion Criteria


- 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

- 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

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 small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma



Garden State Cancer Center Belleville, New Jersey  07103