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

August 2, 2012 updated by: Case Comprehensive Cancer Center

A Phase II Trial of Celecoxib Plus Interferon Alpha in Metastatic Renal Cell Carcinoma Patients With 3+ COX-2 Tumor Immunostaining

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Criteria

  • Patients must have histologically-confirmed metastatic renal cell carcinoma
  • Patients must have 3+ (on a scale of 0 to 3+) COX-2 staining in >= 10% of the RCC tumor cells from baseline tumor tissue
  • Patients must not have received any prior cytokine therapy for renal cell carcinoma
  • Patients may have received any number of prior non-cytokine systemic therapies for metastatic RCC
  • Patients must have undergone nephrectomy (radical or partial)
  • All patients must be at least 2 weeks from prior systemic therapy, radiation or major surgery
  • Patients must have measurable disease per RECIST criteria
  • ECOG performance status 0 or 1
  • Leukocytes >= 3,000/mL
  • Absolute neutrophil count >= 1,500/mL
  • Platelets >= 75,000/mL
  • Total bilirubin =< 1.5x institutional upper limit
  • AST(SGOT)/ALT(SGPT) =< 2.5x institutional upper limit
  • Creatinine =< 2.0x institutional upper limit
  • No significant cardiovascular disease including congestive heart failure (New York Heart Association Class III or IV), active angina pectoris requiring nitrate therapy, uncontrolled dysrhythmias or recent cardiovascular event (defined as any of the following within the previous 6 months: TIA/CVA, MI, vascular surgery)
  • Ability to understand and the willingness to sign a written informed consent document
  • Patients with any untreated CNS metastases are excluded from this clinical trial; patients who have undergone surgery and/or radiation for CNS metastases are eligible for enrollment if they do not have CNS metastases that have not been treated, are at least 2 weeks from treatment of CNS metastases without evidence of CNS disease progression (stable CT scan or MRI) and are off steroids; all patients must undergo an MRI or infused CT scan of the brain prior to enrollment
  • 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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: laboratory biomarker analysis
Correlative studies
Other: flow cytometry
Correlative studies
Other: immunohistochemistry staining method
Correlative studies
Other Names:
  • immunohistochemistry
Other: immunologic technique
Correlative studies
Other Names:
  • immunological laboratory methods
  • laboratory methods, immunological
Other: reverse transcriptase-polymerase chain reaction
Correlative studies
Other Names:
  • RT-PCR
Other: polymerase chain reaction
Correlative studies
Other Names:
  • PCR
Drug: celecoxib
Given orally
Other Names:
  • Celebrex
  • SC-58635
  • YM 177
Biological: recombinant interferon alfa-2b
Given subcutaneously
Other Names:
  • Alfatronol
  • Glucoferon
  • Heberon Alfa
  • IFN alpha-2B
  • Intron A
  • interferon alfa-2B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate Assessed by RECIST Criteria.
Time Frame: at week 4 of cycle 2 and every other cycle thereafter
The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started, including baseline). The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. Objective response will be assessed by RECIST criteria.
at week 4 of cycle 2 and every other cycle thereafter

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: death
Overall survival measured in months and summarized using the Kaplan-Meier method.
death
Duration of Response
Time Frame: end of study
The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started, including baseline). The duration of overall CR is measured from the time measurement criteria are first met for CR until the first date that recurrent disease is objectively documented.
end of study
Progression-free Survival
Time Frame: to progression
Progression-free survival measured in months and summarized using the Kaplan-Meier method. Time to objective progression will be measured from the start of treatment until the criteria for progression are met, taking as reference the smallest measurements recorded since the treatment started, including baseline.
to progression
Number of Patients With Statistically Significant Change in Cellular Immune Parameters From Baseline to 2 Months
Time Frame: at two months from start of treatment
To evaluate the effect of celecoxib and interferon alpha therapy on cellular immune parameters. Absolute change following two cycles of therapy.
at two months from start of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Comprehensive Cancer Center

Investigators

  • Principal Investigator: Brian Rini, Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

July 6, 2010

First Submitted That Met QC Criteria

July 7, 2010

First Posted (Estimate)

July 8, 2010

Study Record Updates

Last Update Posted (Estimate)

August 7, 2012

Last Update Submitted That Met QC Criteria

August 2, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CASE8805
  • NCI-2010-01390 (Other Identifier: NCI/CTRP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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