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SB-715992 in Treating Patients With Metastatic or Unresectable Solid Tumors or Hodgkin's or Non-Hodgkin's Lymphoma
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00101244
  Purpose

RATIONALE: Drugs used in chemotherapy, such as SB-715992, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase I trial is studying the side effects and best dose of SB-715992 in treating patients with metastatic or unresectable solid tumors or Hodgkin's or non-Hodgkin's lymphoma.


Condition Intervention Phase
Lymphoma
Unspecified Adult Solid Tumor, Protocol Specific
Drug: ispinesib
Phase I

MedlinePlus related topics: Cancer Lymphoma
Drug Information available for: Ispinesib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase I, Open-Label, Dose-Escalation Study Of SB-715992 Administered Days 1-3 Of A 21-Day Cycle In Patients With Solid Tumors

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

Estimated Enrollment: 31
Study Start Date: March 2005
Detailed Description:

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose and dose-limiting toxicity of SB-715992 in patients with metastatic or unresectable solid tumor or Hodgkin's or non-Hodgkin's lymphoma.
  • Determine the safety and tolerability of this drug in these patients.

Secondary

  • Determine clinical response in patients treated with this drug.
  • Determine the pharmacokinetics of this drug in these patients.
  • Determine drug metabolism and biomarkers of efficacy of this drug in these patients.
  • Determine the toxicity of this drug in these patients.
  • Determine the potential interaction of the study drug with other drugs in these patients.

OUTLINE: This is an open-label, dose-escalation, multicenter study.

Patients receive SB-715992 IV over 1 hour on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of SB-715992 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 10 additional patients are treated at the MTD

Patients are followed for 4 weeks.

PROJECTED ACCRUAL: A total of 18-31 patients will be accrued for this study within 11-19 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed malignancy of 1 of the following types:

    • Solid tumor
    • Hodgkin's or non-Hodgkin's lymphoma

      • Bone marrow assessment must have been performed within the past 6 weeks
  • Metastatic or unresectable disease
  • Standard curative or palliative therapy does not exist or is no longer effective
  • No known symptomatic or untreated brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • More than 12 weeks

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin normal
  • AST and ALT ≤ 2.5 times upper limit of normal (ULN)

Renal

  • Creatinine ≤ 1.5 times ULN OR
  • Creatinine clearance ≥ 60 mL/min

Cardiovascular

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other uncontrolled illness
  • No active or ongoing infection
  • No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 4 weeks since prior immunotherapy
  • No concurrent colony-stimulating factors (CSFs) during the first course of study drug administration
  • No concurrent prophylactic CSFs
  • No concurrent anticancer biologic therapy

Chemotherapy

  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

Endocrine therapy

  • Male patients receiving treatment for prostate cancer must continue luteinizing hormone-releasing hormone agonist therapy to maintain castrate levels of testosterone
  • Concurrent hormone replacement therapy allowed
  • Concurrent megestrol for supportive care allowed provided started ≥ 1 month before study entry
  • No concurrent dexamethasone
  • No concurrent anticancer hormonal therapy

Radiotherapy

  • More than 4 weeks since prior radiotherapy
  • No prior radiotherapy to ≥ 50% of total marrow volume
  • No concurrent anticancer radiotherapy

Surgery

  • Not specified

Other

  • Recovered from all prior therapy
  • More than 4 weeks since prior epidermal growth factor receptor inhibitors
  • More than 7 days since prior and no concurrent grapefruit juice
  • More than 14 days since prior and no concurrent moderate to significant inhibitors or inducers of CYP3A4, including the following:

    • Clarithromycin
    • Erythromycin
    • Troleandomycin
    • Itraconazole
    • Ketoconazole
    • Fluconazole (dose > 200 mg/day)
    • Voriconazole
    • Nefazodone
    • Fluvoxamine
    • Verapamil
    • Diltiazem
    • Bitter orange
    • Phenytoin
    • Carbamazepine
    • Phenobarbital
    • Rifampin
    • Rifabutin
    • Rifapentine
    • Hypericum perforatum (St. John's wort)
    • Modafinil
    • Oxcarbazepine
  • No other investigational agents within 28 days before, during, and for at least 14 days after study treatment
  • More than 6 months since prior and no concurrent amiodarone
  • Concurrent bisphosphonates for supportive care allowed provided started ≥ 1 month before study entry
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent cytotoxic anticancer therapy
  • No other concurrent anticancer therapy
  • No concurrent use of any of the following:

    • Ajmaline
    • Cimetidine
    • Clotrimazole
    • Cyclosporine
    • Fluoxetine
    • Indinavir
    • Nelfinavir
    • Paroxetine
    • Quinidine
    • Ritonavir
    • Saquinavir
    • Sertraline
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00101244

Locations
United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
Study Chair: Patricia M. LoRusso, DO Barbara Ann Karmanos Cancer Institute
  More Information

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

Study ID Numbers: CDR0000404369, WSU-C-2818, NCI-6785
Study First Received: January 7, 2005
Last Updated: May 23, 2008
ClinicalTrials.gov Identifier: NCT00101244  
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
recurrent adult Hodgkin lymphoma
unspecified adult solid tumor, protocol specific
stage IV adult Hodgkin lymphoma
adult grade III lymphomatoid granulomatosis
recurrent adult grade III lymphomatoid granulomatosis
splenic marginal zone lymphoma
recurrent adult Burkitt lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent mantle cell lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
stage IV adult Burkitt lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV adult lymphoblastic lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV mantle cell lymphoma
stage IV marginal zone lymphoma
stage IV small lymphocytic lymphoma

Study placed in the following topic categories:
Hodgkin's disease
Hodgkin lymphoma, adult
Lymphoma, Mantle-Cell
Lymphoma, Follicular
Lymphoma, small cleaved-cell, diffuse
Lymphoma, B-Cell, Marginal Zone
Lymphoma, large-cell, immunoblastic
Lymphoma, large-cell
Lymphoma, B-Cell
Lymphomatoid granulomatosis
Burkitt's lymphoma
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Large-Cell, Immunoblastic
Waldenstrom macroglobulinemia
Hodgkin Disease
Lymphoma
Chronic lymphocytic leukemia
Lymphomatoid Granulomatosis
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Leukemia, B-cell, chronic
Lymphoblastic lymphoma
Mantle cell lymphoma
Recurrence
Lymphatic Diseases
Waldenstrom Macroglobulinemia
Burkitt Lymphoma
B-cell lymphomas
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

ClinicalTrials.gov processed this record on January 14, 2009