Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Ispinesib in Treating Patients With Metastatic or Unresectable Kidney Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed Not specified NCI CCUM-14577A 7673, NCI-7673, NCT00354250

Objectives

Primary

1. Assess the efficacy of ispinesib (SB-715992), in terms of complete or partial response rate, in patients with metastatic or unresectable renal cell cancer who have received at least 1 prior therapy.

Secondary

1. Assess the overall survival of these patients.
2. Assess the time to progression in these patients.
3. Evaluate the qualitative and quantitative toxicities of this regimen.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed renal cell carcinoma (RCC)
  • Metastatic disease OR unresectable primary tumor
    • Patients with metastatic disease who have a resectable primary tumor and are deemed a surgical candidate may have undergone prior resection



• Received ≥ 1 prior therapy and meets 1 of the following criteria:
  • Discontinued therapy due to toxicity
  • Evidence of disease progression after therapy



• 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
    • Soft tissue disease within a prior irradiated field must have progressed to be considered assessable
    • Patients must also have measurable disease outside of the irradiated field



• No prior or concurrent brain metastases (treated or untreated)
  • Patients with clinical concern for brain metastases must have a negative brain CT scan or MRI within the past 56 days

Prior/Concurrent Therapy:

• See Disease Characteristics
• No prior tubule, DNA, or mitosis-targeting agents for RCC
• At least 28 days since prior surgery and recovered
• At least 28 days since prior antiangiogenesis agents or immunotherapy comprising interferon and/or aldesleukin and recovered
• At least 21 days since prior radiotherapy and recovered
• More than 28 days since prior investigational agents
• More than 6 months since prior and no concurrent amiodarone
• More than 14 days since prior and no concurrent inhibitors or inducers of CYP3A4, including any of the following:
  • Rifapentine
  • Rifabutin
  • Rifampin
  • Troleandomycin
  • Erythromycin
  • Clarithromycin
  • Itraconazole
  • Ketoconazole
  • Voriconazole
  • Fluconazole (doses > 200 mg/day)
  • Nefazodone
  • Fluvoxamine
  • Verapamil
  • Diltiazem
  • Bitter orange
  • Phenytoin
  • Carbamazepine
  • Phenobarbital
  • Oxcarbazepine
  • Hypericum perforatum (St. John's wort)
  • Modafinil
• No concurrent colony-stimulating factors
• No other concurrent investigational agents during and for ≥ 14 days after the last dose of study drug or after post-treatment blood draws are completed, whichever is earlier
• No concurrent combination antiretroviral therapy for HIV-positive patients

Patient Characteristics:

• ECOG performance status 0-2
• Platelet count ≥ 100,000/mm³
• Absolute granulocyte count ≥ 1,500/mm³
• Hemoglobin ≥ 9 g/dL
• SGOT and SGPT ≤ 2.5 times upper limit of normal
• Bilirubin < 2 mg/dL
• Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 40 mL/min
• Corrected QT interval < 0.47 seconds
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No psychiatric illness or social situation that would preclude study compliance
• No uncontrolled intercurrent illness including, but not limited to, any of the following:
  • Ongoing or active infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • Cardiac arrhythmia
• No other prior malignancy, except for the following:
  • Adequately treated basal cell or squamous cell skin cancer
  • Adequately treated stage I or II cancer for which patient is currently in complete remission
  • Any other cancer for which patient has been disease free for 5 years
• No history of allergic reaction attributed to compounds of similar chemical or biological composition to study drug

Expected Enrollment

A total of 60 patients will be accrued for this study.

Outcomes

Response rate (partial response and complete response)

Overall survival
Time to progression
Toxicity

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.

Lee RT, Beekman KE, Hussain M, et al.: A University of Chicago consortium phase II trial of SB-715992 in advanced renal cell cancer. Clin Genitourin Cancer 6 (1): 21-4, 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

University of Michigan Comprehensive Cancer Center

Walter Stadler, MD, FACP, Protocol chair		Ph: 773-702-4400; 888-824-0200 Email: wstadler@medicine.bsd.uchicago.edu

Registry Information
Official Title		A Phase II Study of SB-715992 (NSC-727990, IND-70273) in Advanced Renal Cell Cancer
Trial Start Date		2006-05-10
Registered in ClinicalTrials.gov		NCT00354250
Date Submitted to PDQ		2006-05-10
Information Last Verified		2006-09-11
NCI Grant/Contract Number		CA46592