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ABR-217620/Naptumomab Estafenatox With Interferon-alpha (IFN-alpha) Compared to IFN-alpha Alone in Patients With Advanced Renal Cell Carcinoma

NCT00420888 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 526

Last updated 2015-07-22

No results posted yet for this study

Summary

The drug ABR-217620/naptumomab estafenatox is a fusion of two proteins, one that recognizes tumor cells and one that triggers an attack on the tumor cells by activating some white blood cells belonging to the body's normal immune system. This results in an accumulation of white blood cells in the cancer that can fight the cancer. This study will compare the safety and effectiveness (assessed by tumor status and survival) of ABR-217620/naptumomab estafenatox when given with standard therapy IFN-alpha to IFN-alpha alone in patients with advanced renal cell carcinoma (RCC).

Conditions

Interventions

DRUG

ABR-217620/naptumomab estafenatox

10 mcg/kg or 15 mcg/kg, 5 minute bolus intravenous injection on 4 consecutive days / 8 week cycle repeated 3 times

DRUG

IFN-alpha

3 MIU, 6 MIU, and 9 MIU, subcutaneous or intramuscular injection 3 times / week

Sponsors & Collaborators

  • Active Biotech AB

    lead INDUSTRY

Principal Investigators

  • Thore Nederman, PhD · Active Biotech AB

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2013-01-31
Completion
2013-01-31

Countries

  • Bulgaria
  • Romania
  • Russia
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT00420888 on ClinicalTrials.gov