NCT00738452

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1 lung-cancer

Timeline
Completed

Started Aug 2008

Longer than P75 for phase_1 lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 6, 2008

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 19, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 20, 2008

Completed
9.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2018

Completed
Last Updated

February 13, 2018

Status Verified

February 1, 2018

Enrollment Period

9.5 years

First QC Date

August 19, 2008

Last Update Submit

February 9, 2018

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancerstage II non-small cell lung cancerstage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancer

Outcome Measures

Primary Outcomes (2)

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

    6 weeks after treatment

  • Dose-limiting toxicity

    6 weeks after treatment

Secondary Outcomes (3)

  • Progression-free survival

    6 months after treatment

  • Overall survival

    6 months after treatment

  • Sites of recurrence

    6 months after treatment

Study Arms (1)

Treatment (chemo, monoclonal antibody therapy, radiation)

EXPERIMENTAL

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 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.

Other: high performance liquid chromatographyOther: pharmacological studyProcedure: radionuclide imagingProcedure: single photon emission computed tomographyRadiation: radiation therapyRadiation: yttrium Y 90 anti-CEA monoclonal antibody cT84.66

Interventions

high performance liquid chromatographyOTHER

Blood evaluation 0 minutes, 1 hour, 4 hours, 1 day, 2 days, 3-5 days and 6-7 days post start of antibody infusion. 24 hour urine sample evaluation daily for 5 consecutive days post antibody infusion.

Treatment (chemo, monoclonal antibody therapy, radiation)
pharmacological studyOTHER

Blood evaluation 0 minutes, 1 hour, 4 hours, 1 day, 2 days, 3-5 days and 6-7 days post start of antibody infusion. 24 hour urine sample evaluation daily for 5 consecutive days post antibody infusion.

Treatment (chemo, monoclonal antibody therapy, radiation)
radionuclide imagingPROCEDURE

Approximately 1-3 hours, 1 day, 2 days, 3-5 days and 6-7 days post infusion.

Treatment (chemo, monoclonal antibody therapy, radiation)
single photon emission computed tomographyPROCEDURE

Approximately 2 days and 3-5 days post infusion

Treatment (chemo, monoclonal antibody therapy, radiation)
radiation therapyRADIATION

3-6 mCi Indium-111 labeled cT84.66(5mg) and dose escalation (depending on toxicities observed from previous dosages) from a starting dose of 8mCi/m2 Y-90-cT84.66.

Treatment (chemo, monoclonal antibody therapy, radiation)
yttrium Y 90 anti-CEA monoclonal antibody cT84.66RADIATION

Dose escalation (depending on toxicities observed from previous dosages) from a starting dose of 8mCi/m2 Y-90-cT84.66.

Treatment (chemo, monoclonal antibody therapy, radiation)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • +1 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

Chromatography, High Pressure LiquidRadiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Chromatography, LiquidChromatographyChemistry Techniques, AnalyticalInvestigative TechniquesTherapeutics

Study Officials

  • Jeffrey Y. Wong, MD

    City of Hope Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

  • Marianna Koczywas, MD

    City of Hope Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2008

First Posted

August 20, 2008

Study Start

August 6, 2008

Primary Completion

February 7, 2018

Study Completion

February 7, 2018

Last Updated

February 13, 2018

Record last verified: 2018-02

Locations

US(1)