Study of Interleukin-2, Interferon-alpha and Bevacizumab in Metastatic Kidney Cancer

NCT01274273 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2014-12-02

No results posted yet for this study

Summary

The purpose of this study is to determine whether interleukin-2, interferon-alpha in combination with bevacizumab are effective in the treatment of metastatic renal cell carcinoma (mRCC).

Conditions

  • Metastatic Renal Cell Carcinoma

Interventions

DRUG

Interleukin-2

2.4 MIU/m2 s.c. two times daily, 5 days per week, weeks 1 and 2, every 28-day-cycle, for a maximum of 9 cycles (i.e.for a maximum of 9 months).

DRUG

Interferon Alfa-2b

IFN-alfa given as one priming-week of daily IFN 3.0 MIU, followed by up to 9 treatment cycles (i.e. for a maximum of 9 months) with IFN-alfa 3.0 MIU as a fixed dose s.c. once daily - 5 days per week.

DRUG

Bevacizumab

Bevacizumab doses of 10 mg per kilogram of body weight, given every two weeks i.v. until disease progression, unacceptable toxicity, withdrawal of consent or a maximum of 1 year following obtaining no evidence of disease (NED).

Sponsors & Collaborators

  • Danish Renal Cancer Study Group

    collaborator NETWORK
  • University of Aarhus

    lead OTHER

Principal Investigators

  • Frede Donskov, MD, DMSc · Aarhus University Hospital

  • Poul Geertsen, MD, PhD · University of Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Denmark

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01274273 on ClinicalTrials.gov