Clinical trial NCT00354250 (phase 2, status: completed)
Conditions: recurrent renal cell cancer, stage iii renal cell cancer, stage iv renal cell cancer
ICD codes: C96.20, C96.29, D47.09, C96.20, C96.29, D47.09, C96.20, C96.29, D47.09
Drugs: ispinesib
SMILES: CC(C)[C@@H](N(CCCN)C(=O)C1=CC=C(C)C=C1)C1=NC2=CC(Cl)=CC=C2C(=O)N1CC1=CC=CC=C1
Eligibility criteria:

        Inclusion Criteria:

          -  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

                    -  Antibiotics: rifampin, rifabutin, rifapentine

                    -  Miscellaneous: St. John's Wort, modafinil

          -  Patients must not have a history of allergic reactions attributed to compounds of
             similar chemical or biologic composition to SB-715992

          -  Patients must not have any uncontrolled intercurrent illness including, but not
             limited to, ongoing or active infection, symptomatic congestive heart failure,
             unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/ social
             situations that would limit compliance with study requirements

          -  Patients with immune deficiency are at increased risk of lethal infections when
             treated with marrow-suppressive therapy; therefore, HIV-positive patients receiving
             combination anti-retroviral therapy are not eligible because of possible
             pharmacokinetic interactions with SB-715992

          -  No other prior malignancy is allowed except for the following: adequately treated
             basal cell or squamous cell skin cancer, adequately treated Stage I or II cancer from
             which the patient is currently in complete remission, or any other cancer from which
             the patient has been disease-free for 5 years