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Celecoxib and Recombinant Interferon Alfa-2b in Metastatic Kidney Cancer Who Have Undergone Surgery

NCT ID: NCT01158534

Last Updated: 2012-08-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2010-10-31

Brief Summary

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RATIONALE: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Recombinant interferon alfa-2b may interfere with the growth of cancer cells and slow the growth of kidney cancer. Giving celecoxib together with recombinant interferon alpha-2b may kill more tumor cells and be an effective treatment for metastatic kidney cancer.

PURPOSE: This phase II trial is studying how well giving celecoxib together with recombinant interferon alfa-2b works in treating patients with metastatic kidney cancer who have undergone surgery.

Detailed Description

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PRIMARY OBJECTIVES:

I. To estimate the objective response rate of interferon alpha plus celecoxib in metastatic RCC patients with 3+ COX-2 tumor immunostaining.

SECONDARY OBJECTIVES:

I. To compare cellular immune parameters in metastatic RCC patients with 3+ COX-2 tumor immunostaining to patients with \< 1+ tumor immunostaining.

II. To evaluate the effect of celecoxib and interferon alpha therapy on cellular immune parameters in metastatic RCC patients with 3+ COX-2 tumor immunostaining.

OUTLINE:

Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Conditions

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Renal Cell Cancer Stage IV Renal Cell Cancer

Keywords

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recurrent renal cell cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm I

Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group Type EXPERIMENTAL

celecoxib

Intervention Type DRUG

Given orally

recombinant interferon alfa-2b

Intervention Type BIOLOGICAL

Given subcutaneously

polymerase chain reaction

Intervention Type OTHER

Correlative studies

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

reverse transcriptase-polymerase chain reaction

Intervention Type OTHER

Correlative studies

immunologic technique

Intervention Type OTHER

Correlative studies

immunohistochemistry staining method

Intervention Type OTHER

Correlative studies

flow cytometry

Intervention Type OTHER

Correlative studies

Interventions

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celecoxib

Given orally

Intervention Type DRUG

recombinant interferon alfa-2b

Given subcutaneously

Intervention Type BIOLOGICAL

polymerase chain reaction

Correlative studies

Intervention Type OTHER

laboratory biomarker analysis

Correlative studies

Intervention Type OTHER

reverse transcriptase-polymerase chain reaction

Correlative studies

Intervention Type OTHER

immunologic technique

Correlative studies

Intervention Type OTHER

immunohistochemistry staining method

Correlative studies

Intervention Type OTHER

flow cytometry

Correlative studies

Intervention Type OTHER

Other Intervention Names

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Celebrex SC-58635 YM 177 Alfatronol Glucoferon Heberon Alfa IFN alpha-2B interferon alfa-2B Intron A PCR RT-PCR immunological laboratory methods laboratory methods, immunological immunohistochemistry

Eligibility Criteria

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Inclusion Criteria

* Patients may not be concurrently receiving any other investigational agents
* Pregnant women; women of childbearing potential must have a negative pregnancy test prior to enrollment and use adequate contraception while on study and for one month thereafter
* Concurrent systemic steroid therapy is prohibited (inhaled or topical steroids as well as physiologic replacement doses of steroids are permitted)
* Patients with a history of a severe allergic reaction (defined as a grade 4 rash, a reaction requiring steroids or epinephrine or any degree of airway compromise) to sulfonamide or sulfonamide derivatives drugs are excluded; this includes, but is not limited to, sulfonamide antibiotics such as sulfadiazine, sulfamethoxazole, sulfisoxazole and sulfacetamide and sulfonamide derivatives such as celecoxib, valdecoxib, diuretics (HCTZ, furosemide), sulfonylureas, dorzolamide and sumatriptan
* Karnofsky \>= 70%
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Case Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brian Rini

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Locations

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Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2010-01390

Identifier Type: OTHER

Identifier Source: secondary_id

CASE8805

Identifier Type: -

Identifier Source: org_study_id