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

NCT01176552 | Completed Phase 2 DMC

• 1 other identifier: U1111-1114-6557
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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).

Conditions

Renal Cell Carcinoma

Keywords

Kidney Cancer; Renal cell carcinoma; High risk; Adjuvant therapy

Outcome Measures

Primary Outcomes (1)

• Disease-free survival (DFS)

  3.5 years

Secondary Outcomes (3)

• Progression rate

  28 months

• Overall survival (OS)

  5 years

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  12 months

Study Arms (1)

Study group: GM-CSF, IFN, IL-2

EXPERIMENTAL

Drug: GM-CSF, IFN alpha and IL-2

Interventions

GM-CSF, IFN alpha and IL-2 DRUG

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.

Study group: GM-CSF, IFN, IL-2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kidney Cancer Research Bureau: lead

Study Sites (1)

N.N. Blokhin Russian Cancer Research Center

Moscow, 115478, Russia

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms

Interventions

Granulocyte-Macrophage Colony-Stimulating Factor; Interferon-alpha; Interleukin-2

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Interferon Type I; Interferons; Interleukins; Lymphokines

Study Officials

• Lev Demidov, M.D., D.Sc.

  N.N. Blokhin Russian Cancer Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 13, 2010
• First Posted: August 6, 2010
• Study Start: May 1, 2004
• Primary Completion: September 1, 2008
• Study Completion: May 1, 2010
• Last Updated: August 24, 2010

Record last verified: 2010-08

Locations

RU (1)