NCT00104767CompletedPhase 1
A Phase I Trial to Evaluate Cyclooxygenase 2 Inhibitor-Mediated Modulation of T Regulatory Cells in Advanced Non-Small Cell Lung Cancer (NSCLC)
Jonsson Comprehensive Cancer Center1 site in 1 country7 target enrollmentStarted: January 2009Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Optimal biologic dose (OBD) necessary to decrease peripheral blood lymphocyte (PBL) CD4+ and CD25+ T-lymphocyte regulatory cells at 1 week
Study Overview
Brief Summary
RATIONALE: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also stimulate the immune system in different ways and stop tumor cells from growing.
PURPOSE: This phase I trial is studying the side effects and best dose of celecoxib in treating patients with stage IIIB or stage IV non-small cell lung cancer.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
celecoxib
Experimental
Intervention: celecoxib (Drug)
Outcomes
Primary Outcomes
Optimal biologic dose (OBD) necessary to decrease peripheral blood lymphocyte (PBL) CD4+ and CD25+ T-lymphocyte regulatory cells at 1 week
Time Frame: 7 days
Secondary Outcomes
- OBD necessary to decrease PBL FOXP3 levels at 1 week(7 dayd)
- Function of CD4+ and CD25+ T-regulatory cells at 1 week(7 days)
- Markers of cyclooxygenase-2 (COX-2) dependent gene expression before and after treatment at 1 week(7 days)
Investigators
Study Sites (1)
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