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A Phase I Trial to Evaluate Cyclooxygenase 2 Inhibitor-Mediated Modulation of T Regulatory Cells in Advanced Non-Small Cell Lung Cancer (NSCLC)


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

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Trial Information

A Phase I Trial to Evaluate Cyclooxygenase 2 Inhibitor-Mediated Modulation of T Regulatory Cells in Advanced Non-Small Cell Lung Cancer (NSCLC)


OBJECTIVES:

Primary

- Determine the optimal biologic dose (OBD) of celecoxib that is necessary to decrease
peripheral blood lymphocyte CD4+ and CD25+ T-lymphocyte regulatory cells in patients
with stage IIIB or IV non-small cell lung cancer.

Secondary

- Determine the OBD of this drug that is necessary to decrease peripheral blood
lymphocyte FOXP3 levels in these patients.

OUTLINE: This is a nonrandomized, dose-escalation study.

Patients receive oral celecoxib twice daily on days 1-7 in the absence of unacceptable
toxicity.

Cohorts of 3 patients receive escalating doses of celecoxib until the optimal biologic dose
(OBD) is determined. The OBD is defined as the lowest dose that results in the maximum
decrease in peripheral blood lymphocyte CD4+ and CD25+ T-lymphocyte regulatory cells and
FOXP3 levels where no dose-limiting toxicity occurs. An additional 15 patients are treated
at the OBD.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.


Inclusion Criteria:



- Histologically confirmed non-small cell lung cancer

- Stage IIIB or IV disease

- Radiographically measurable disease

- 18 and over

- Performance status: ECOG 0-2

- Renal: Creatinine ≤ 2 mg/dL

- Negative pregnancy test

- Fertile patients must use effective contraception

- More than 4 weeks since prior chemotherapy

- Endocrine therapy: More than 4 weeks since prior corticosteroids; No concurrent
corticosteroids, including chronic corticosteroids, except for medically-indicated
topical steroids

- Radiotherapy: More than 4 weeks since prior radiotherapy

- More than 4 weeks since other prior anticancer therapy

- More than 4 weeks since prior non-cytotoxic investigational agents

- At least 72 hours since prior nonsteroidal anti-inflammatory drugs (NSAIDs)

Exclusion Criteria:

- pregnant or nursing

- comorbid disease, psychiatric condition, chronic medical condition, or laboratory
abnormality that would preclude study treatment or compliance with study requirements

- hypersensitivity to celecoxib, sulfonamides, aspirin, other NSAIDs, or any study
reagent

- history of gastrointestinal ulceration, bleeding, or perforation

- other concurrent cyclooxygenase-2 or -3 inhibitors

- other concurrent NSAIDs

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Optimal biologic dose (OBD) necessary to decrease peripheral blood lymphocyte (PBL) CD4+ and CD25+ T-lymphocyte regulatory cells at 1 week

Outcome Time Frame:

7 days

Safety Issue:

Yes

Principal Investigator

Edward Garon, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000415733

NCT ID:

NCT00104767

Start Date:

January 2009

Completion Date:

Related Keywords:

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

Name

Location

Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781