Clinical trial NCT01158534: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Renal Cell Cancer
Stage IV Renal Cell Cancer
Keywords: recurrent renal cell cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2010-07-08
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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%

Primary outcomes:
measure: Objective Response Rate Assessed by RECIST Criteria.
timeFrame: at week 4 of cycle 2 and every other cycle thereafter
Secondary outcomes:
measure: Overall Survival
timeFrame: death
measure: Duration of Response
timeFrame: end of study
measure: Progression-free Survival
timeFrame: to progression
measure: Number of Patients With Statistically Significant Change in Cellular Immune Parameters From Baseline to 2 Months
timeFrame: at two months from start of treatment
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
name: Brian Rini
role: PRINCIPAL_INVESTIGATOR
References: