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

August 22, 2010 updated by: Kidney Cancer Research Bureau

Granulocyte-macrophage Colony-stimulating Factor, Interferon Alpha and Interleukin-2 as Adjuvant Treatment for High-risk Renal Cell Carcinoma

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 115478
        • N.N. Blokhin Russian Cancer Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group: GM-CSF, IFN, IL-2
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease-free survival (DFS)
Time Frame: 3.5 years
3.5 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kidney Cancer Research Bureau

Investigators

  • Principal Investigator: Lev Demidov, M.D., D.Sc., N.N. Blokhin Russian Cancer Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

April 13, 2010

First Submitted That Met QC Criteria

August 5, 2010

First Posted (Estimate)

August 6, 2010

Study Record Updates

Last Update Posted (Estimate)

August 24, 2010

Last Update Submitted That Met QC Criteria

August 22, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U1111-1114-6557

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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