Kidney Cancer Clinical Trial
Official title:
A Randomized Controlled Phase III Adjuvant Trial of High-Dose Bolus IL-2 in Patients With High-Risk Renal Cell Carcinoma
Verified date | January 2017 |
Source | Loyola University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to assess the efficacy of post-operative high-dose bolus interleukin-2 (IL-2) in patients with high-risk renal cell carcinoma (RCC).
Status | Completed |
Enrollment | 69 |
Est. completion date | August 2002 |
Est. primary completion date | August 2002 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years and older |
Eligibility |
Inclusion Criteria - An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Adequate organ function as defined by a white blood cell (WBC) count of 4,000/L; a platelet count of 100,000/L; a Hemoglobin level of 10 g/dL; a serum creatinine of 1.5 mg/dL or creatinine clearance of 60 mL/min; and a direct bilirubin level of 1.5 mg/dL. - Forced expiratory volume at 1 second more than 2.0 L or 75% of predicted for height and age from pre-enrollment pulmonary function testing. - No history or evidence of cardiac disease on ECG - No prior systemic treatment for RCC, but patients may have received prior locoregional radiation therapy to solitary resectable metastases, which must have undergone surgical resection before enrollment. - No prior history of invasive malignancy in the past 5 years - Human immunodeficiency virus (HIV) negative - Female patients must not be pregnant or planning to become pregnant Exclusion criteria • Age younger than 16 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan |
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Our Lady of Mercy Medical Center | Bronx | New York |
United States | Carolinas Medical Center | Charlotte | North Carolina |
United States | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan |
United States | Cancer Center and Beckman Research Institute, City of Hope | Duarte | California |
United States | Indiana University Cancer Center | Indianapolis | Indiana |
United States | Norris Cotton Cancer Center | Lebanon | New Hampshire |
United States | Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California |
United States | USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California |
United States | Loyola University Medical Center | Maywood | Illinois |
United States | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee |
United States | Summit Medical Center | Oakland | California |
United States | Earle A. Chiles Research Institute at Providence Portland Medical Center | Portland | Oregon |
United States | University of Texas Health Science Center at San Antonio | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
Loyola University | Chiron Corporation |
United States,
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* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disease free survival | Disease free survival will be compared between the two cohorts (i.e., IL-2 versus Observation). Time will be calculated as the difference in months from date of treatment to date of death or recurrence (whichever occurs first). Patients remaining disease-free will be censored at the date of last follow-up. | 60 months | No |
Secondary | Overall survival | Overall survival will be compared between the two cohorts (i.e., IL-2 versus Observation). Time will be calculated as the difference in months from date of treatment to date of death. Living patients will be censored at the date of last follow-up. | 60 months | No |
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