Expired Study
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Charlotte, North Carolina 28232


Purpose:

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill kidney cancer cells. PURPOSE: Phase II trial to study the effectiveness of low-dose interleukin-2 in treating patients with metastatic or recurrent kidney cancer.


Study summary:

OBJECTIVES: - Assess the response rate and survival of patients with metastatic renal cell carcinoma treated with low-dose intravenous interleukin-2. - Assess the toxicity associated with this treatment. OUTLINE: Patients receive low-dose intravenous interleukin-2 every 8 hours for a maximum of 15 doses in week 1 and again in week 3. Stable and responding patients receive a second course beginning approximately 2 months after initiation of the first course. Responding patients may continue therapy every 2 months provided toxicity is limited. Patients whose diseased kidney comprises the bulk of the tumor burden at entry undergo nephrectomy. Patients are followed for survival. PROJECTED ACCRUAL: A total of 14 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed renal cell carcinoma (RCC) that is metastatic or recurrent - No central nervous system or major nerve involvement - No more than 25% estimated hepatic replacement by tumor on CT or MRI - Measurable disease required PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 80%-100% Life expectancy: - Greater than 3 months Hematopoietic: - Platelet count at least 80,000/mm3 Hepatic: - Bilirubin normal - AST and ALT no greater than 3 times normal Renal: - Creatinine normal Cardiovascular: - Stress cardiac exam normal (exam performed in patients aged 50 and older and in those with potential cardiac disease suggested by history, physical exam, or EKG) Pulmonary: - FEV1 and VC greater than 65% of predicted (tests performed in patients with significant smoking history and in those with potential pulmonary disease suggested by history, physical exam, or x-ray) Other: - No sites of ongoing bleeding - No HIV antibody or AIDS - No hepatitis B antigen - No systemic infection - No requirement for steroids - No psychiatric disease that precludes informed consent or safe administration of immunotherapy - No second malignancy except: - Basal cell carcinoma - In situ cervical cancer - Other cancer provided all evaluable lesions are documented RCC - No pregnant or nursing women - Effective contraception required of fertile women PRIOR CONCURRENT THERAPY: Biologic therapy - No prior interleukin-2 therapy Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified Other - At least 28 days since therapy for RCC


NCT ID:

NCT00002846


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: October 18, 2017

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