Granulocyte-macrophage Colony-stimulating Factor, Interferon and Interleukin-2 as Adjuvant Treatment for Renal Cancer

Phase 2

Completed

• Conditions: Renal Cell Carcinoma
• Interventions: Drug: GM-CSF, IFN alpha and IL-2

• Registration Number: NCT01176552
• Lead Sponsor: Kidney Cancer Research Bureau

Brief Summary

This prospective study assesses toxicity and potential efficacy of granulocyte-macrophage colony-stimulating factor (GM-CSF), interferon (IFN) alpha and interleukin-2 (IL-2) postoperatively in patients with high-risk renal cell carcinoma (RCC).

Detailed Description

Patients with high-risk RCC have a dismal prognosis. To date, no effective adjuvant therapy exists for this patients category. We suggest that combination of granulocyte-macrophage colony-stimulating factor (GM-CSF), interferon alpha (IFN) and interleukin-2 (IL-2) stimulate immune system from dendritic cells till cytotoxic T-lymphocytes step by step and eliminate residuary tumor cells.

This prospective, non-randomized, phase II trial assessed low-dose GM-CSF, IFN and IL-2 postoperatively in patients with high-risk renal cell carcinoma.

Study Timeline

• Study Start: 2004-05
• Primary Completion: 2008-09
• Study First Submitted: 2010-04-13
• Study Completion: 2010-05
• Status Verified: 2010-08
• Study First Submitted QC: 2010-08-05
• Study First Posted: 2010-08-06
• Last Update Submitted: 2010-08-22
• Last Update Posted: 2010-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• completely resected advanced high-risk RCC
• T3b-c, T4, or N1-2, or M1 disease resected to no evidence of disease (AJCC-TNM, 2002) Patients must have recovered from any effects of surgery, which must have been - excellent performance status (Eastern Cooperative Oncology Group performance status of 0 or 1);
• adequate organ function defined as WBC count 4,000/µL, platelet count 100,000/µL, hemoglobin 10 g/dL, serum creatinine 1.5 mg/dL or creatinine clearance 60 mL/min, and direct bilirubin 1.5 mg/dL; and 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
• age 18 years and older

Exclusion Criteria

• history or evidence of cardiac disease on ECG or autoimmunity
• prior systemic treatment for RCC
• history of invasive malignancy in the past 5 years or human immunodeficiency virus positivity
• positive pregnancy test

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study group: GM-CSF, IFN, IL-2	GM-CSF, IFN alpha and IL-2	-

Primary Outcome Measures

Name	Time	Method
Disease-free survival (DFS)	3.5 years

Secondary Outcome Measures

Name	Time	Method
Progression rate	28 months
Overall survival (OS)	5 years
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	12 months

Trial Locations

Locations (1)

N.N. Blokhin Russian Cancer Research Center; 🇷🇺 Moscow, Russian Federation