A Phase II Trial of BMS-247550 (NSC 710428), an Epothilone B Analog, in Patients With Renal Cell Carcinoma
Protocol # 02-C-0130
- Why is this trial important?
- Who is eligible for this trial?
- What types of drugs or therapies are being used?
- What is the study outline?
- What is the frequency and duration of the visits?
- What are the costs?
- Who is the Principal Investigator?
- Where is this trial taking place?
- Who are the contacts for this trial?
- Where can additional information be found?
Why is this trial important?
Approximately 32,000 people will be diagnosed with renal carcinoma in the U.S. each year and an estimated 13,000 people will die from this disease. In recent years, progress has been made with an increase in the number of treatment options for patients with renal cell carcinoma. Nonetheless, most patients with advanced tumors will continue to succumb to their disease unless better therapies, attacking the cancer by diverse mechanisms, are developed.
Who is eligible for this trial? (PDQ)
- 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 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
What types of drugs or therapies are being used?
Ixabepilone (BMS-247550, NSC 710428), an analog of epothilone B, is a novel chemotherapeutic agent that stabilizes the microtubules of dividing cells, resulting in death of the cell. Ixabepilone works in a similar manner to another class of drugs, the taxanes (e.g. paclitaxel, docetaxel), which are currently in use in a variety of cancers. However, ixabepilone has been shown to be more potent in laboratory and human studies, may have fewer side effects, and is not as prone to tumor resistance as the taxanes.
What is the study outline? (PDQ)
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
What is the frequency and duration of the visits?
Patients who enroll in this study will receive ixabepilone for 5 consecutive days as an outpatient; patients only receive ixabepilone as an inpatient if there is an indication for them to be in the hospital. Patients receiving treatment who do not live in D.C. metro area (i.e., same-day driving distance to the NIH campus) usually arrive 1 day prior to the start of therapy. Patients who are traveling by plane are usually able to return home on the same day they complete their treatment, although they may stay until the following day. The first cycle of therapy may require a slightly longer stay (1-2 additional days) to facilitate research studies.
What are the costs?
There is no charge for medical care received at the National Institutes of Health (NIH) Clinical Center. Patients will be responsible for travel costs for their initial screening visits. In most cases, once patients are enrolled in a trial, the National Cancer Institute (NCI) will pay the transportation costs for all subsequent trial-related visits for patients who do not live in the local area. In addition, these patients will receive a small per diem to help offset the costs of meals and lodging if they are being treated as outpatients.
It will be important to maintain your current insurance plan to cover all medical care that is provided away from the NIH Clinical Center.
No U.S. citizen or permanent U.S. resident residing in the U.S. who otherwise meets the eligibility requirements will be denied enrollment in clinical research protocols because of their inability to pay the costs of travel and subsistence.
Who is the Principal Investigator?
Dr. Antonio Tito Fojo was born in Havana, Cuba, moved to the United States with his family in 1960, and became a U.S. citizen in 1970. He received his M.D. and Ph.D. from the University of Miami. He completed 3 years of training in internal medicine at Washington University/Barnes Hospital in St. Louis, and after a year as chief resident came to the NCI as a clinical associate in the Medicine Branch, now the Cancer Therapeutics Branch. After 3 years with Drs. Ira Pastan and Michael Gottesman, he assumed the position of senior investigator in the Cancer Therapeutics Branch.
Where is this trial taking place?
Warren Grant Magnuson Clinical Center
National Institutes of Health
NCI Medical Oncology Branch
10 Center Drive
Bethesda, Maryland 20892
Who are the contacts for this trial?
Antonio Tito Fojo, M.D., Ph.D.
Principal Investigator
Phone: 301-402-1357
tfojo@helix.nih.gov
Referrals:
Maureen Edgerly, R.N., M.A.
Research Nurse
Phone: 301-435-5604
Fax: 301-402-1608
edgerlym@mail.nih.gov
Where can additional information be found?
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