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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01176552
First Posted: August 6, 2010
Last Update Posted: August 24, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Kidney Cancer Research Bureau
  Purpose
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).

Condition Intervention Phase
Renal Cell Carcinoma Drug: GM-CSF, IFN alpha and IL-2 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Granulocyte-macrophage Colony-stimulating Factor, Interferon Alpha and Interleukin-2 as Adjuvant Treatment for High-risk Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Kidney Cancer Research Bureau:

Primary Outcome Measures:
  • Disease-free survival (DFS) [ Time Frame: 3.5 years ]

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

Estimated Enrollment: 35
Study Start Date: May 2004
Study Completion Date: May 2010
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01176552


Locations
Russian Federation
N.N. Blokhin Russian Cancer Research Center
Moscow, Russian Federation, 115478
Sponsors and Collaborators
Kidney Cancer Research Bureau
Investigators
Principal Investigator: Lev Demidov, M.D., D.Sc. N.N. Blokhin Russian Cancer Research Center
  More Information

Responsible Party: Lev Demidov, N.N. Blokhin Russian Cancer Research Center
ClinicalTrials.gov Identifier: NCT01176552     History of Changes
Other Study ID Numbers: U1111-1114-6557
First Submitted: April 13, 2010
First Posted: August 6, 2010
Last Update Posted: August 24, 2010
Last Verified: August 2010

Keywords provided by Kidney Cancer Research Bureau:
Kidney Cancer
Renal cell carcinoma
High risk
Adjuvant therapy

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Interferons
Interleukin-2
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs