The drug ABR-217620/naptumomab estafenatox is a fusion of two proteins, one that recognizes tumor cells and one that triggers an attack on the tumor cells by activating some white blood cells belonging to the body's normal immune system. This results in an accumulation of white blood cells in the cancer that can fight the cancer. This study will compare the safety and effectiveness (assessed by tumor status and survival) of ABR-217620/naptumomab estafenatox when given with standard therapy IFN-alpha to IFN-alpha alone in patients with advanced renal cell carcinoma (RCC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
526
10 mcg/kg or 15 mcg/kg, 5 minute bolus intravenous injection on 4 consecutive days / 8 week cycle repeated 3 times
3 MIU, 6 MIU, and 9 MIU, subcutaneous or intramuscular injection 3 times / week
Department of Chemotherapy, University General Hospital for Active Treatment "Georgi Stranski"
Pleven, Bulgaria
1st Internal Department District Dispensary for Cancer Diseases with Inpatient Hospital
Plovdiv, Bulgaria
Multifile Hospital "Aleksandrovska", Urology Clinic, Department of Oncourology
Sofia, Bulgaria
Oncology Clinic, University General Hospital for Active Treatment "Tzaritza Yoanna"
Sofia, Bulgaria
Urology Clinic, General Hospital for Active Treatment "St. Anna"
Varna, Bulgaria
Time to death
Time frame: every 12 weeks, including after a maximum of 18 months of study treatment
Progression-free survival time
Time frame: every 12 weeks for the 18-month treatment period and also every 12 weeks after the treatment period
Objective tumor response rate
Time frame: every 12 weeks for the 18-month treatment period
Best overall response
Time frame: every 12 weeks for the 18-month treatment period
Duration of response
Time frame: every 12 weeks for the 18-month treatment period
Changes in sum of target lesions
Time frame: every 12 weeks for the 18-month treatment period
Immunological response in patients on combined treatment of ABR-217620/naptumomab estafenatox and IFN-alpha
Time frame: Weeks 1, 9, 17, 25, 73
Vital signs
Time frame: every visit through Week 25, plus Week 73
Physical measurements
Time frame: Weeks 1, 9, 17, 25, 73
Adverse events
Time frame: every visit through Week 73
Laboratory safety assessments
Time frame: Weeks 1, 2, 3, 5, 9, 10, 13, 17, 18, 21, 25, and 73
Pharmacokinetic parameters of ABR-217620/naptumomab estafenatox
Time frame: Weeks 1, 9, and 17
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Department of Chemotherapy, Inter-district Dispensary for Cancer Diseases with Inpatient Hospital
Veliko Tarnovo, Bulgaria
Fundeni Clinical Institute - Urology Department
Bucharest, Romania
Dinu Uromedica
Bucharest, Romania
"Prof. Dr. Th. Burghele" Clinical Hospital, Urology Clinic
Bucharest, Romania
"I. Chiricuta" Institute of Oncology
Cluj-Napoca, Romania
...and 41 more locations