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

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. |
- Disease-free survival (DFS) [ Time Frame: 3.5 years ]
- 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 ]

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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 |
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

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
Russian Federation | |
N.N. Blokhin Russian Cancer Research Center | |
Moscow, Russian Federation, 115478 |
Principal Investigator: | Lev Demidov, M.D., D.Sc. | N.N. Blokhin Russian Cancer Research Center |
Responsible Party: | Lev Demidov, N.N. Blokhin Russian Cancer Research Center |
ClinicalTrials.gov Identifier: | NCT01176552 |
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 |
Kidney Cancer Renal cell carcinoma High risk Adjuvant therapy |
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 Interferon-alpha Interferon alpha-2 Interferon-alfa-1b Antiviral Agents Anti-Infective Agents Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents |