Celecoxib and Recombinant Interferon Alfa-2b in Metastatic Kidney Cancer Who Have Undergone Surgery
Condition: Renal Cell Cancer; Stage IV Renal Cell Cancer
MeSH terms: Carcinoma, Renal Cell
Intervention: celecoxib; recombinant interferon alfa-2b; polymerase chain reaction; laboratory biomarker analysis; reverse transcriptase-polymerase chain reaction; immunologic technique; immunohistochemistry staining method; flow cytometry
Intervention description: Given orally; Given subcutaneously; Correlative studies; Correlative studies; Correlative studies; Correlative studies; Correlative studies; Correlative studies
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Celecoxib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: recurrent renal cell cancer

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.
    

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%