Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
University of Michigan Cancer Center National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00354250 |
RATIONALE: Ispinesib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well ispinesib works in treating patients with metastatic or unresectable kidney cancer.
Condition | Intervention | Phase |
---|---|---|
Kidney Cancer |
Drug: ispinesib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of SB-715992 (NSC-727990, IND-70273) in Advanced Renal Cell Cancer |
Estimated Enrollment: | 60 |
Study Start Date: | May 2006 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive ispinesib (SB-715992) IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 3 years.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed renal cell carcinoma (RCC)
Metastatic disease OR unresectable primary tumor
Received ≥ 1 prior therapy and meets 1 of the following criteria:
Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension
Soft tissue disease that has been irradiated in the past 2 months is not assessable as measurable disease
No prior or concurrent brain metastases (treated or untreated)
PATIENT CHARACTERISTICS:
No uncontrolled intercurrent illness including, but not limited to, any of the following:
No other prior malignancy, except for the following:
PRIOR CONCURRENT THERAPY:
More than 14 days since prior and no concurrent inhibitors or inducers of CYP3A4, including any of the following:
United States, Illinois | |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | |
Maywood, Illinois, United States, 60153 | |
Ingalls Cancer Care Center at Ingalls Memorial Hospital | |
Harvey, Illinois, United States, 60426 | |
Joliet Oncology-Hematology Associates, Limited - West | |
Joliet, Illinois, United States, 60435 | |
Oncology Hematology Associates of Central Illinois, PC - Peoria | |
Peoria, Illinois, United States, 61615-7828 | |
University of Chicago Cancer Research Center | |
Chicago, Illinois, United States, 60637-1470 | |
United States, Indiana | |
CCOP - Northern Indiana CR Consortium | |
South Bend, Indiana, United States, 46601 | |
Fort Wayne Medical Oncology and Hematology | |
Fort Wayne, Indiana, United States, 46885-5099 | |
United States, Maryland | |
Greenebaum Cancer Center at University of Maryland Medical Center | |
Baltimore, Maryland, United States, 21201 | |
United States, Michigan | |
Oncology Care Associates, PLLC | |
Saint Joseph, Michigan, United States, 49085 | |
University of Michigan Comprehensive Cancer Center | |
Ann Arbor, Michigan, United States, 48109-0942 | |
United States, Missouri | |
David C. Pratt Cancer Center at St. John's Mercy | |
Saint Louis, Missouri, United States, 63141 | |
United States, Wisconsin | |
Medical College of Wisconsin Cancer Center | |
Milwaukee, Wisconsin, United States, 53226 |
Study Chair: | Walter M. Stadler, MD, FACP | University of Chicago |
Study ID Numbers: | CDR0000485369, CCUM-14577A, NCI-7673 |
Study First Received: | July 19, 2006 |
Last Updated: | August 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00354250 |
Health Authority: | United States: Food and Drug Administration |
recurrent renal cell cancer stage III renal cell cancer stage IV renal cell cancer |
Urogenital Neoplasms Renal cancer Urologic Neoplasms Kidney cancer Recurrence Carcinoma Urologic Diseases |
Kidney Neoplasms Carcinoma, Renal Cell Kidney Diseases Adenocarcinoma Urinary tract neoplasm Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |