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
  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:


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

ClinicalTrials.gov processed this record on April 17, 2014