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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:
Kidney Cancer Research Bureau
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
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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: 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| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01176552
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
| 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 |
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 |
ClinicalTrials.gov processed this record on June 23, 2017