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

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ClinicalTrials.gov Identifier: NCT01176552

Recruitment Status : Completed

First Posted : August 6, 2010

Last Update Posted : August 24, 2010

Sponsor:

Information provided by:

Kidney Cancer Research Bureau

Study Description

Brief 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).

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

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 Design


Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	35 participants
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
Study Start Date :	May 2004
Actual Primary Completion Date :	September 2008
Actual Study Completion Date :	May 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Interferon

Genetic and Rare Diseases Information Center resources: Renal Cell Carcinoma

U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Older Adult)
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 Posted:	August 6, 2010 Key Record Dates
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

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