CompletedPhase 1NCT00738452

Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Stage I-IIIB Non-Small Cell Lung Cancer After Completion of Radiation Therapy Alone or Combined Radiation Therapy and Chemotherapy

RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as carboplatin, paclitaxel, cisplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiolabeled monoclonal antibodies can find tumor cells and carry tumor-killing substances to them without harming normal cells. Giving radiation therapy and combination chemotherapy together before radiolabeled monoclonal antibody therapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of radiolabeled monoclonal antibody therapy when given after radiation therapy and combination chemotherapy in treating patients with stages I-IIIB non-small cell lung cancer.

Checked against the public recordLast updated Feb 13, 2018 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 1
U.S. locations1
SponsorCity of Hope Medical Center
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
City of Hope Medical Center
Interventions being studied
Other: high performance liquid chromatography; Other: pharmacological study; Procedure: radionuclide imaging; Procedure: single photon emission computed tomography; Radiation: radiation therapy; Radiation: yttrium Y 90 anti-CEA monoclonal antibody cT84.66
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • City of Hope Comprehensive Cancer CenterDuarte, California

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 13, 2018. Always confirm current availability with the study team.

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