SB-715992 in Treating Patients With Metastatic or Recurrent Malignant Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00095953
Recruitment Status : Completed
First Posted : November 9, 2004
Last Update Posted : May 17, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
National Cancer Institute (NCI) ( NCIC Clinical Trials Group )

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as SB-715992, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well SB-715992 works in treating patients with metastatic or recurrent malignant melanoma.

Condition or disease Intervention/treatment Phase
Melanoma (Skin) Drug: ispinesib Phase 2

Detailed Description:


  • Determine the efficacy of SB-715992, in terms of response rate, in patients with previously untreated metastatic or recurrent malignant melanoma.
  • Determine the toxic effects of this drug in these patients.
  • Determine the early progression rate and response duration in patients treated with this drug.
  • Determine the pharmacokinetics of this drug in these patients.
  • Correlate pharmacokinetics with safety and efficacy endpoints of this drug in these patients.
  • Correlate β-tubulin and kinesin spindle protein expression in tumor tissue with clinical outcomes in patients treated with this drug.

OUTLINE: This is a nonrandomized, multicenter study.

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

All patients are followed at 4 weeks after completion of protocol therapy. Patients with ongoing complete response, partial response, or stable disease are followed every 3 months thereafter until relapse.

PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study within 12-14 months.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of SB-715992 (NSC 727990) in Previously Untreated Patients With Metastatic or Recurrent Malignant Melanoma
Study Start Date : November 2004
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Intervention Details:
  • Drug: ispinesib
    SB-715992 will be given as a 1 hour intravenous infusion in a dose of 18 mg/m2 once every 3 weeks.

Primary Outcome Measures :
  1. Response [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Toxicity [ Time Frame: 2 years ]
  2. Pharmacokinetics at day 1 of course 1 (day 1 of course 2 if dose is changed) [ Time Frame: 2 years ]
  3. Molecular correlates on archival tissue, fresh tumor tissue, and peripheral blood mononuclear cells (PVMCs) [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed malignant melanoma

    • Previously untreated metastatic or recurrent disease
    • Considered incurable by standard therapies
  • Measurable disease

    • At least one unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
    • Bone metastases are not considered measurable disease
    • Outside any previously irradiated area

      • Patients whose sole site of measurable disease is in a previously irradiated area are ineligible unless there is evidence of progression or new lesions documented in the irradiated field
  • No known CNS metastases

    • CT scans or MRI are not required to rule out CNS metastases unless patient exhibits neurological signs or symptoms
    • Patients with a prior solitary brain metastasis surgically resected with no evidence of residual disease are eligible provided CT scan or MRI confirms no evidence of disease within the past 28 days
  • Archival paraffin tumor specimen available



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 12 weeks


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


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


  • Creatinine ≤ 1.5 times ULN


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


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other malignancy except adequately treated nonmelanoma skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively treated solid tumors with no evidence of disease for ≥ 5 years
  • No other uncontrolled illness
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study participation
  • No history of allergic reactions attributed to compounds of similar chemical or biological composition to SB-715992


Biologic therapy

  • At least 3 months since prior adjuvant immunotherapy
  • No prior immunotherapy for metastatic or recurrent disease


  • No prior chemotherapy, including regional therapy

Endocrine therapy

  • Not specified


  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy except for low-dose, non-myelosuppressive radiotherapy


  • See Disease Characteristics
  • At least 4 weeks since prior major surgery


  • More than 28 days since prior investigational agents
  • More than 14 days since prior and no concurrent use of any of the following CYP3A4 inhibitors or inducers:

    • Clarithromycin
    • Erythromycin
    • Troleandomycin
    • Itraconazole
    • Ketoconazole
    • Fluconazole (≤ 200 mg/day allowed)
    • Voriconazole
    • Nefazodone
    • Fluvoxamine
    • Verapamil
    • Diltiazem
    • Grapefruit juice
    • Bitter orange
    • Phenytoin
    • Carbamazepine
    • Phenobarbital
    • Oxcarbazepine
    • Rifampin
    • Rifabutin
    • Rifapentine
    • Hypericum perforatum (St. John's wort)
    • Modafinil
  • At least 6 months since prior and no concurrent amiodarone
  • No concurrent antiretroviral therapy for HIV-positive patients
  • No other concurrent anticancer treatment
  • No other concurrent investigational therapies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00095953

Canada, British Columbia
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
Fraser Valley Cancer Centre at British Columbia Cancer Agency
Surrey, British Columbia, Canada, V3V 1Z2
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Nova Scotia
Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Toronto Sunnybrook Regional Cancer Centre at Sunnybrook and Women's College Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2L-4M1
Sponsors and Collaborators
NCIC Clinical Trials Group
National Cancer Institute (NCI)
Study Chair: Christopher Lee, MD BCCA - Fraser Valley Cancer Centre

Publications of Results:
Responsible Party: NCIC Clinical Trials Group Identifier: NCT00095953     History of Changes
Other Study ID Numbers: I169
CDR0000391842 ( Other Identifier: PDQ )
First Posted: November 9, 2004    Key Record Dates
Last Update Posted: May 17, 2013
Last Verified: September 2011

Keywords provided by National Cancer Institute (NCI) ( NCIC Clinical Trials Group ):
recurrent melanoma
stage IV melanoma

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas