Back to results

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

Primary Purpose

Renal Cell Cancer, Stage IV Renal Cell Cancer

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

celecoxib

recombinant interferon alfa-2b

polymerase chain reaction

laboratory biomarker analysis

reverse transcriptase-polymerase chain reaction

immunologic technique

immunohistochemistry staining method

flow cytometry

About this trial

This is an interventional treatment trial for Renal Cell Cancer focused on measuring recurrent renal cell cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%

Sites / Locations

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

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.

Outcomes

Primary Outcome Measures

Objective Response Rate Assessed by RECIST Criteria.

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.

Secondary Outcome Measures

Overall Survival

Overall survival measured in months and summarized using the Kaplan-Meier method.

Duration of Response

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.

Progression-free Survival

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.

Number of Patients With Statistically Significant Change in Cellular Immune Parameters From Baseline to 2 Months

To evaluate the effect of celecoxib and interferon alpha therapy on cellular immune parameters. Absolute change following two cycles of therapy.

Full Information

NCT ID

NCT01158534

First Posted

July 6, 2010

Last Updated

August 2, 2012

Sponsor

Case Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT01158534

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Completed

Study Start Date

March 2006 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Case Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Renal Cell Cancer, Stage IV Renal Cell Cancer

Keywords

recurrent renal cell cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm I

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

celecoxib

Other Intervention Name(s)

Celebrex, SC-58635, YM 177

Intervention Description

Given orally

Intervention Type

Biological

Intervention Name(s)

recombinant interferon alfa-2b

Other Intervention Name(s)

Alfatronol, Glucoferon, Heberon Alfa, IFN alpha-2B, interferon alfa-2B, Intron A

Intervention Description

Given subcutaneously

Intervention Type

Other

Intervention Name(s)

polymerase chain reaction

Other Intervention Name(s)

PCR

Intervention Description

Correlative studies

Intervention Type

Other

Intervention Name(s)

laboratory biomarker analysis

Intervention Description

Correlative studies

Intervention Type

Other

Intervention Name(s)

reverse transcriptase-polymerase chain reaction

Other Intervention Name(s)

RT-PCR

Intervention Description

Correlative studies

Intervention Type

Other

Intervention Name(s)

immunologic technique

Other Intervention Name(s)

immunological laboratory methods, laboratory methods, immunological

Intervention Description

Correlative studies

Intervention Type

Other

Intervention Name(s)

immunohistochemistry staining method

Other Intervention Name(s)

immunohistochemistry

Intervention Description

Correlative studies

Intervention Type

Other

Intervention Name(s)

flow cytometry

Intervention Description

Correlative studies

Primary Outcome Measure Information:

Title

Objective Response Rate Assessed by RECIST Criteria.

Description

Time Frame

at week 4 of cycle 2 and every other cycle thereafter

Secondary Outcome Measure Information:

Title

Overall Survival

Description

Overall survival measured in months and summarized using the Kaplan-Meier method.

Time Frame

death

Title

Duration of Response

Description

Time Frame

end of study

Title

Progression-free Survival

Description

Time Frame

to progression

Title

Number of Patients With Statistically Significant Change in Cellular Immune Parameters From Baseline to 2 Months

Description

To evaluate the effect of celecoxib and interferon alpha therapy on cellular immune parameters. Absolute change following two cycles of therapy.

Time Frame

at two months from start of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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%

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brian Rini

Organizational Affiliation

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs