Ispinesib in Treating Patients With Metastatic or Unresectable Kidney Cancer

Completed · Phase 2

Conditions studied: Recurrent Renal Cell Cancer, Stage III Renal Cell Cancer, Stage IV Renal Cell Cancer

In brief

This phase II trial is studying how well ispinesib works in treating patients with metastatic or unresectable kidney cancer. Ispinesib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key facts

Study ID

NCT00354250

Run by

National Cancer Institute (NCI)

People needed

60

Starts

2006-05-01

Last updated by the study team

2013-06-05

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have histologically or cytologically confirmed renal cell carcinoma which is metastatic (M1); histopathology is not restricted; patients with unresectable primary tumor (but MO) are also eligible
• Patients must have measurable disease; x-rays, scans or physical examinations used for tumor measurement must have been completed within 28 days prior to registration; x-rays, scans or physical examinations for non-measurable disease must have been completed within 42 days prior to registration
• Patients with metastatic disease who have a resectable primary tumor and are deemed a surgical candidate may have undergone resection and have recovered from surgery; at least 28 days must have elapsed since surgery and patient must have recovered from any adverse effects of surgery
• Patients must have discontinued therapy due to toxicity or demonstrated progression of disease following a minimum of one prior therapy; prior therapies may include: immunotherapy with either interferon (IFN) and/or Interleukin-2 (IL-2) or prior anti-angiogenesis agents; at least 28 days must have elapsed since the last treatment; patients must have recovered from any adverse effects of prior therapy
• Patients may have received prior radiation therapy; at least 21 days must have elapsed since completion of prior radiation therapy; patients must have recovered from all associated toxicities at the time of registration
• Patients may not have received prior tubule, DNA, or mitosis targeting agents for the treatment of renal cell carcinoma
• Patients must have a ECOG performance status of 0 - 2
• Pregnant or nursing women may not participate in this trial; women and men of reproductive potential must have agreed to use an effective contraceptive method; women of child-bearing potential must have a negative urine pregnancy test
• Patients with a history of brain metastases or who currently have treated or untreated brain metastases are not eligible; patients with clinical evidence of brain metastases must have a brain CT or MRI negative for metastatic disease within 56 days prior to registration
• Absolute granulocyte count (AGC) ≥ 1,500 cells/mm3, hemoglobin ≥ 9 mg/dl, and a platelet count ≥ 100,000 cells/mm3 within 14 days prior to registration
• Patients must have a total bilirubin < 2 mg/dl obtained within 14 days prior to registration
• Patients must have SGOT and SGPT =< 2.5 x institutional upper limit of normal within 14 days prior to registration
• Patients must have a serum creatinine =< 2.0 or a calculated creatinine clearance >= 40 mL/min for patients with creatinine levels above institutional normal; this must be obtained within 14 days prior to registration
• Patients must have a corrected QT interval less than 0.47 seconds
• All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
• Prohibited medications; SB-715992 is a moderate to significant in vitro inhibitor of CYP3A4; the following lists of medications/substances are moderate to significant inhibitors/inducers of CYP3A4 that, if administered concomitantly with SB-715992, may alter study drug exposure; the use of these medications/ substances within 14 days (=< 6 months for amiodarone) prior to the administration of the first dose of SB-715992 through discontinuation from the study is prohibited
• Inhibitors of CYP3A4:
• Antibiotics: Clarithromycin, erythromycin, troleandomycin, rifabutin, rifapentine
• Antifungals: itraconazole, ketoconazole, fluconazole (doses > 200 mg/day), voriconazole
• Antidepressants: nefazodone, fluovoxamine
• Calcium channel blockers: verapamil, diltiazem
• Miscellaneous: amiodarone*, bitter orange
• Use of amiodarone within 6 months prior to the administration of the first dose of SB-715992 is prohibited.
• Inducers of CYP3A4:
• Anticonvulsants: phenytoin, carbamazepine, phenobarbital, oxcarbazepine

Where it is running

• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.