PEG-Interferon Alfa-2b and Sorafenib in Treating Patients With Unresectable or Metastatic Kidney Cancer

Stopped early · Phase 1

Conditions studied: Kidney Cancer

In brief

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.

Key facts

Study ID

NCT00589550

Run by

Thomas Olencki

People needed

1

Starts

2008-02-01

Expected to finish

2009-01-01

Last updated by the study team

2015-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must have histologically or cytologically confirmed clear cell renal cell carcinoma (RCC)
• Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension and is ≥ 1.0 cm by spiral CT scan
• No prior treatment except
• PATIENT CHARACTERISTICS:
• ECOG performance status 0-1
• Life expectancy > 6 months
• Good/intermediate Motzer prognostic status
• ANC ≥ 1,000/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 10.0 g/dL
• Total bilirubin ≤ 2.0 mg/dL
• AST and ALT < 2.5 times normal
• Creatinine ≤ 1.8 mg/dL OR creatinine clearance > 50 mL/min
• Calcium < 12 mg/dL (when corrected for serum albumin)
• INR < 1.5 times upper limit of normal
• Adequate cardiac function, defined as left ventricular ejection fraction ≥ 40% by 2D echo
• Pulse oximetry ≥ 90% at rest on room air
• Not pregnant
• Negative pregnancy test
• Fertile patients must use effective contraception
• No evidence of bleeding diathesis
• No uncontrolled coagulation disorders
• No active infections requiring IV antibiotics
• No known HIV, hepatitis C, or hepatitis B
• No autoimmune disease requiring ongoing therapy

Where it is running

• Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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