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

Stage IV Renal Cell Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01158534
• Other study ID #: CASE8805
• Secondary ID: NCI-2010-01390
• Status: Completed
• Phase: Phase 2
• First received: July 6, 2010
• Last updated: August 2, 2012
• Start date: March 2006
• Est. completion date: October 2010

Study information

• Verified date: August 2012
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: October 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Renal Cell Cancer
• Stage IV Renal Cell Cancer

Intervention

Drug:
• celecoxib
Given orally

Biological:
• recombinant interferon alfa-2b
Given subcutaneously

Other:
• polymerase chain reaction
Correlative studies
• laboratory biomarker analysis
Correlative studies
• reverse transcriptase-polymerase chain reaction
Correlative studies
• immunologic technique
Correlative studies
• immunohistochemistry staining method
Correlative studies
• flow cytometry
Correlative studies

Locations

Country	Name	City	State
United States	Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at week 4 of cycle 2 and every other cycle thereafter	No
Secondary	Overall Survival	Overall survival measured in months and summarized using the Kaplan-Meier method.	death	No
Secondary	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.	end of study	No
Secondary	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.	to progression	No
Secondary	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.	at two months from start of treatment	No