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

• Status: Terminated
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thomas Olencki
• Collaborator: Schering-Plough
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Niacinamide; Peginterferon alfa-2b; Sorafenib

Criteria

Inclusion Criteria:

• 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

• No requirement for adrenal replacement

• No angina (controlled or uncontrolled)

• No uncontrolled hypertension

• No history of other major medical illnesses including, but not limited to, any of the following:

• Cardiac ischemia

• Myocardial infarction

• Major cardiac arrhythmias

• Inflammatory bowel disorders

• No other prior malignancy except for previously treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 3 years

• No significant psychiatric disease that, in the opinion of the principal investigator, would preclude giving adequate informed consent or render immunotherapy unsafe

PRIOR CONCURRENT THERAPY:

• No prior treatment for RCC except sunitinib malate

• Patients may have progressed or have been intolerant to sunitinib malate

• No prior systemic treatment for metastatic disease (other than sunitinib malate)

• No prior organ allografts

• At least 2 weeks since prior laparoscopic/robotic surgery

• At least 4 weeks since prior open nephrectomy

• More than 4 weeks since prior and no concurrent radiotherapy or other surgery

• More than 4 weeks since prior systemic steroids

• More than 2 weeks since prior topical, injected, or inhaled steroids

• No concurrent steroid therapy

• No concurrent Hypericum perforatum (St. John's wort)