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

Information source: Case Comprehensive Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Renal Cell Cancer; Stage IV Renal Cell Cancer

Intervention: celecoxib (Drug); recombinant interferon alfa-2b (Biological); polymerase chain reaction (Other); laboratory biomarker analysis (Other); reverse transcriptase-polymerase chain reaction (Other); immunologic technique (Other); immunohistochemistry staining method (Other); flow cytometry (Other)

Phase: Phase 2

Status: Completed

Sponsored by: Case Comprehensive Cancer Center

Official(s) and/or principal investigator(s):
Brian Rini, Principal Investigator, Affiliation: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

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.

Clinical Details

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

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

Primary outcome: Objective Response Rate Assessed by RECIST Criteria.

Secondary outcome:

Overall Survival

Duration of Response

Progression-free Survival

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

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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%

Locations and Contacts

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland, Ohio 44195, United States
Additional Information

Starting date: March 2006
Last updated: August 2, 2012

Page last updated: August 23, 2015

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