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Investigator(s):
Antonio Tito Fojo, M.D., Ph.D. Principal Investigator Phone: 301-402-1357 tfojo@helix.nih.gov
Referral Contact(s):
Maureen Edgerly, R.N., M.A. Research Nurse Phone: 301-435-5604 Fax: 301-402-1608 edgerlym@mail.nih.gov

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Primary Eligibility:

• Histologically or cytologically confirmed renal cell carcinoma:
  • Clear cell
  • Type I or II papillary
  • Chromophobe
  • Collecting duct
  • Medullary
• Received prior, ineligible for, or refused interleukin-2
• Measurable disease
• No prior CNS metastases unless control was achieved with radiotherapy or surgical resection at least 6 months before study entry
• At least 4 weeks since prior immunotherapy
• Prior thalidomide, nexavar®, sutent®, and torisel® allowed
• Prior carboxyamidotriasole, sorafenib and sunitinib allowed
• No prior craniospinal or total body irradiation; at least 4 weeks since other prior radiotherapy
• No other concurrent investigational drugs
• No concurrent Hypericum perforatum (St. John’s Wort)
• 18 and over
• ECOG 0-2
• Platelet count at least 100,000/mm³; absolute granulocyte count at least 1,500/mm³
• Bilirubin no greater than 1.5 times normal (3 times normal if clinical evidence of Gilbert’s disease); SGPT and SGOT no greater than 2.5 times normal
• Creatinine no greater than 1.6 mg/dL or creatinine clearance at least 40 mL/min
• HIV negative
• No other serious concurrent medical illness
• No active, uncontrolled infection
• No other nonmalignant systemic disease that would preclude study participation
• No grade 2 or greater motor or sensory neuropathy
• No prior hypersensitivity reactions to agents containing Cremophor EL

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Treatment Plan:

Patients are stratified according to histologic subtype (clear cell vs. type I or II papillary vs. chromophobe, collecting duct, or medullary):

• Patients receive ixabepilone IV over 1 hour on days 1-5
• Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
• Patient undergo two biopsies during cycle 1 (optional)

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 12/4/08
Updated: 12/17/08