PEG-Interferon Alfa-2b and Sorafenib in Treating Patients With Unresectable or Metastatic Kidney Cancer
NCT00589550 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1
Last updated 2015-06-08
Summary
RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also stop the growth of kidney cancer by blocking blood flow to the tumor. Giving PEG-interferon alfa-2b together with sorafenib may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of PEG-interferon alfa-2b and sorafenib in treating patients with unresectable or metastatic kidney cancer.
Conditions
Interventions
- BIOLOGICAL
-
PEG-interferon alfa-2b
administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.
- DRUG
- GENETIC
-
gene expression analysis
- GENETIC
-
polymerase chain reaction
- GENETIC
-
reverse transcriptase-polymerase chain reaction
- OTHER
-
flow cytometry
- OTHER
-
immunoenzyme technique
- OTHER
-
laboratory biomarker analysis
Sponsors & Collaborators
-
Schering-Plough
collaborator INDUSTRY -
Thomas Olencki
lead OTHER
Principal Investigators
-
Thomas E. Olencki, DO · Ohio State University Comprehensive Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-02-29
- Primary Completion
- 2009-01-31
- Completion
- 2009-01-31
Countries
- United States
Study Locations
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