Expired Study
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Charlotte, North Carolina 28232


Purpose:

RATIONALE: Biological therapies use different ways to stimulate the immune system to try to stop cancer cells from growing. Combining interferon alfa and interleukin-2 may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of interferon alfa and interleukin-2 in treating patients with metastatic kidney cancer.


Study summary:

OBJECTIVES: - Evaluate the response and disease-free survival of patients with metastatic renal cell carcinoma treated with subcutaneous interleukin-2 and interferon alfa. - Assess the toxicity of this regimen. OUTLINE: Patients undergo nephrectomy if the diseased kidney makes up the bulk of the tumor burden. All patients receive subcutaneous interferon alfa on day 1 and interleukin-2 on days 3-5 of week 1, followed by reduced doses of interferon alfa and interleukin-2 on days 1, 3, and 5 of weeks 2-6. Patients are assessed for response approximately 2 months after initiating therapy. Patients with stable or responding disease undergo a second course; those who continue to respond may receive additional therapy provided toxicity is limited. Patients are followed for survival. PROJECTED ACCRUAL: 14 patients will be entered.


Criteria:

DISEASE CHARACTERISTICS: - Histologically proven renal cell cancer that is metastatic - No greater than 50% estimated hepatic replacement by tumor on CT or MRI - No symptomatic involvement of the CNS or a major nerve - Measurable disease required - Ineligible for treatment with low-dose interleukin-2 on another CMC protocol PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 50%-100% Life expectancy: - More than 3 months Hematopoietic: - No coagulopathy (i.e., platelet count less than 80,000/mm3) Hepatic: - AST and ALT no greater than 5 times normal Renal: - Creatinine less than 4.0 mg/dL Cardiovascular: - No symptomatic angina - No untreated coronary artery disease - No refractory arrhythmia - No abnormal left ventricular function Pulmonary: - No dyspnea on minimal exertion Other: - No site of ongoing bleeding - No systemic infection - No HIV antibody - No HBsAg - No requirement for steroids - No psychiatric disease that precludes informed consent or protocol treatment - No second malignancy except: - Basal cell skin carcinoma - Carcinoma in situ of the cervix - Not pregnant or nursing - Effective contraception required of fertile women PRIOR CONCURRENT THERAPY: Biologic therapy - No prior interleukin-2 Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified Other - At least 28 days since prior treatment for renal cell cancer


NCT ID:

NCT00002847


Primary Contact:

Study Chair
Richard L. White, MD
Blumenthal Cancer Center at Carolinas Medical Center


Backup Contact:

N/A


Location Contact:

Charlotte, North Carolina 28232
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 22, 2017

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