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Tyrosine Kinase Inhibitor

Sorafenib Tosylate With or Without Recombinant Interferon Alfa-2b in Treating Patients With Metastatic Kidney Cancer

Phase 2
Waitlist Available
Led By Eric Jonasch
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up tumor restaging performed at 8 weeks following baseline, responding or stable participants restaged at 8 week intervals, up to 12 months.
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This randomized phase II trial is studying sorafenib and interferon alfa-2b to see how well they work compared to sorafenib alone in treating patients with metastatic kidney cancer. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Interferon alfa-2b may interfere with the growth of tumor cells. Sorafenib and interferon alfa-2b may also block blood flow to the tumor. Giving sorafenib together with interferon alfa-2b may kill more tumor cells.

Eligible Conditions
  • Kidney Cancer
  • Renal Cell Carcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~tumor restaging performed at 8 weeks following baseline, responding or stable participants restaged at 8 week intervals, up to 12 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and tumor restaging performed at 8 weeks following baseline, responding or stable participants restaged at 8 week intervals, up to 12 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective Response Rate (ORR) Evaluated Using Response Evaluation Criteria in Solid Tumors (RECIST)
Secondary study objectives
Duration of Response for Participants With Stable Disease (N=37) Following Treatment
Median Overall Survival (OS)
Progression-free Survival
+1 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Sorafenib Tosylate, Recombinant interferon alfa-2bExperimental Treatment3 Interventions
Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
Group II: Sorafenib TosylateExperimental Treatment2 Interventions
Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sorafenib
FDA approved
Interferon alfa-2b
FDA approved

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterOTHER
3,071 Previous Clinical Trials
1,803,101 Total Patients Enrolled
National Cancer Institute (NCI)Lead Sponsor
13,955 Previous Clinical Trials
41,111,844 Total Patients Enrolled
Eric JonaschPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
171 Total Patients Enrolled
~4 spots leftby Dec 2025
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