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

NCT ID: NCT01176552

Last Updated: 2010-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-05-31
• Study Completion Date: 2010-05-31

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.

Conditions

Renal Cell Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study group: GM-CSF, IFN, IL-2

Group Type: EXPERIMENTAL

GM-CSF, IFN alpha and IL-2

Intervention Type: DRUG

Treatment during 6 months: GM-CSF, 1 mcg/kg, 3 times per week, subcutaneously, first week of each month; IFN, 10 MIU, 3 times per week, subcutaneously, second week, and IL-2, 1 MIU, 3 tiw, intravenously, third week. Fourth week of each month was free from treatment.

Interventions

GM-CSF, IFN alpha and IL-2

Treatment during 6 months: GM-CSF, 1 mcg/kg, 3 times per week, subcutaneously, first week of each month; IFN, 10 MIU, 3 times per week, subcutaneously, second week, and IL-2, 1 MIU, 3 tiw, intravenously, third week. Fourth week of each month was free from treatment.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kidney Cancer Research Bureau

OTHER

Sponsor Role: lead

Responsible Party

N.N. Blokhin Russian Cancer Research Center

Principal Investigators

Lev Demidov, M.D., D.Sc.

Role: PRINCIPAL_INVESTIGATOR

N.N. Blokhin Russian Cancer Research Center

Locations

N.N. Blokhin Russian Cancer Research Center

Moscow, , Russia

Countries

Russia

Other Identifiers

U1111-1114-6557

Identifier Type: -

Identifier Source: org_study_id