Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Ispinesib in Treating Patients With Metastatic or Unresectable Kidney Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: University of Michigan Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00354250
  Purpose

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

MedlinePlus related topics: Cancer Kidney Cancer
Drug Information available for: Ispinesib
U.S. FDA Resources
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate (partial response and complete response) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
  • Time to progression [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: May 2006
Detailed Description:

OBJECTIVES:

Primary

  • 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

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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00354250

Locations
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
Sponsors and Collaborators
University of Michigan Cancer Center
Investigators
Study Chair: Walter M. Stadler, MD, FACP University of Chicago
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
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

Keywords provided by National Cancer Institute (NCI):
recurrent renal cell cancer
stage III renal cell cancer
stage IV renal cell cancer

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 14, 2009