A Phase I Trial of Radioimmunotherapy (Y-90-Mx-DTPA-cT84.66) After Completion of Radiation Therapy Alone, or Radiation Therapy Plus Systemic Therapy in Unresectable or Medically Inoperable, Non-metastatic CEA-Producing Stage I-IIIB Non-Small Cell Lung Cancer
PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) and associated
toxicities of intravenous yttrium-90 (90Y) chimeric T84.66 (cT84.66) anti-carcinoembryonic
antigen (CEA) antibody targeted radiotherapy delivered after carboplatin/paclitaxel or
cisplatin/etoposide and external beam radiotherapy in patients with CEA positive stage III
unresectable or medically inoperable non-small cell lung cancer.
SECONDARY OBJECTIVES: I. To collect data on the biodistribution, clearance and metabolism of
90Y (yttrium-90) and 111In (indium-111) chimeric T84.66 administered intravenously. II. To
collect data on radiation doses to whole body, normal organs, and tumor through serial
OUTLINE: This is a dose-escalation study of yttrium Y 90 anti-CEA monoclonal antibody
CHEMORADIOTHERAPY: Patients undergo external beam radiation therapy 5 days a week for 45
days. Beginning within 24 hours of the start of radiation therapy, patients receive
paclitaxel intravenously (IV) over 1 hour and carboplatin IV over 30 minutes on days 1, 8,
15, 22, 29, and 36 OR cisplatin IV over 60 minutes on days 1, 8, 29, and 36 and etoposide IV
over 60 minutes on days 1-5 and 29-33.
CONSOLIDATION RADIOIMMUNOTHERAPY: Beginning 6-10 weeks after completion of
chemoradiotherapy, patients with stable disease, partial response, or complete response
receive a therapeutic dose of yttrium Y 90 anti-CEA monoclonal antibody cT84.66 IV.
Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for up to 6 months
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of yttrium Y 90 anti-CEA monoclonal antibody cT84.66
6 weeks after treatment
Jeffrey Y. Wong, MD
Beckman Research Institute
United States: Food and Drug Administration
|City of Hope Comprehensive Cancer Center||Duarte, California 91010|