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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

Thank you

Trial Information

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
nuclear imaging.

OUTLINE: This is a dose-escalation study of yttrium Y 90 anti-CEA monoclonal antibody
cT84.66.

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

Inclusion Criteria


Inclusion criteria:

- Patients must be >= 18 years of age.

- Patients must have a Karnofsky performance status of >= 60%.

- Patients must have histological confirmation non-small cell lung cancer and must have
tumors that produce CEA as documented by either immunohistochemistry or by an
elevated serum CEA level.

- Patients must have American Joint Committee on Cancer (AJCC) Version 7 Stage I-IIIB
non small cell lung cancer (NSCLC) who are not a surgical candidate due to
unresectability or medical inoperability.

- Patients must have undergone radiation therapy alone, or radiation therapy plus
systemic therapy (which includes chemotherapy or tyrosine kinase inhibitors) as
treatment for their lung cancer; patients may receive up to two cycles of
consolidative chemotherapy after radiation therapy +/- chemotherapy; this therapy
must be completed within 6-12 weeks prior to starting treatment on this trial.

- Patients must have had measurable or evaluable disease prior to receiving standard
radiation therapy alone, or radiation therapy plus systemic therapy.

- Patients must have no evidence of progressive disease (therefore, must have stable
disease, partial response or complete response) to the therapy given prior to
enrollment on this study.

- No radiotherapy, immunotherapy, or chemotherapy within the last 5 years prior to the
diagnosis of locally advanced NSCLC; prior adjuvant chemotherapy or tyrosine kinase
inhibitor therapy for early stage, resected NSCLC is allowed as long as it was given
> 12 months prior to the current diagnosis of locally advanced NSCLC.

- Patients must demonstrate an forced expiratory volume in one second (FEV1) >= 0.9.

- Adequate bone marrow function as evidenced by hemoglobin >= 10 gm %, WBC >= 3500/ul,
an absolute granulocyte count of >= 1,500/mm3, and platelets >= 140,000/ul. Patients
may be transfused to reach a hemoglobin >=10 gm %.

- Patients must have a total bilirubin <= 1.5 mg/dL and liver transaminases no higher
then 2 times the upper limit of normal.

- Patients must have serum creatinine <= 1.5 x upper limit of normal (ULN) and a
creatinine clearance >= 45 cc/min (based on Cockcroft Gault formula).

- Patients must not have post-obstructive pneumonia or other serious infection.

- If a patient has previously received murine or chimeric antibody, then serum
anti-antibody testing must be negative.

- Serum HIV testing and hepatitis B surface antigen and hepatitis C antibody testing
must be negative.

- Women of childbearing potential must have a negative serum pregnancy test prior to
entry and while on study must be practicing an effective form of contraception.

Exclusion Criteria:

- Patients with any nonmalignant intercurrent illness (example cardiovascular,
pulmonary, or central nervous system disease) which is either poorly controlled with
currently available treatment or which is of such severity that the investigators
deem it unwise to enter the patient on protocol shall be ineligible.

- Metastatic disease.

- Malignant pleural effusion.

- Patients that did not receive at least 50 Gy thoracic radiation during the course of
radiation +/- systemic therapy.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose of yttrium Y 90 anti-CEA monoclonal antibody cT84.66

Outcome Time Frame:

6 weeks after treatment

Safety Issue:

Yes

Principal Investigator

Jeffrey Y. Wong, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beckman Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

07152

NCT ID:

NCT00738452

Start Date:

August 2008

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage II non-small cell lung cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

City of Hope Comprehensive Cancer CenterDuarte, California  91010