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

NCT01176552 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2010-08-24

No results posted yet for this study

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).

Conditions

Interventions

DRUG

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.

Sponsors & Collaborators

  • Kidney Cancer Research Bureau

    lead OTHER

Principal Investigators

  • Lev Demidov, M.D., D.Sc. · N.N. Blokhin Russian Cancer Research Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2008-09-30
Completion
2010-05-31

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01176552 on ClinicalTrials.gov