Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Kidney Cancer Research Bureau
ClinicalTrials.gov Identifier:
NCT01176552
First received: April 13, 2010
Last updated: August 22, 2010
Last verified: August 2010
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Kidney Cancer Research Bureau:

Primary Outcome Measures:
  • Disease-free survival (DFS) [ Time Frame: 3.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression rate [ Time Frame: 28 months ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: April 13, 2010
Last Updated: August 22, 2010
Health Authority: Russia: Ministry of Health of the Russian Federation

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
Adjuvants, Immunologic
Interferons
 Interleukin-2
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 17, 2013