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Status:

COMPLETED

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

Lead Sponsor:

NCIC Clinical Trials Group

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Melanoma (Skin)

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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-71...

Detailed Description

OBJECTIVES: * 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 d...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • 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
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • ECOG 0-2
  • Life expectancy
  • At least 12 weeks
  • Hematopoietic
  • Absolute granulocyte 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
  • 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 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
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • At least 3 months since prior adjuvant immunotherapy
  • No prior immunotherapy for metastatic or recurrent disease
  • Chemotherapy
  • No prior chemotherapy, including regional therapy
  • Endocrine therapy
  • Not specified
  • Radiotherapy
  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy except for low-dose, non-myelosuppressive radiotherapy
  • Surgery
  • See Disease Characteristics
  • At least 4 weeks since prior major surgery
  • Other
  • 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

Exclusion

    Key Trial Info

    Start Date :

    November 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    September 1 2008

    Estimated Enrollment :

    17 Patients enrolled

    Trial Details

    Trial ID

    NCT00095953

    Start Date

    November 1 2004

    End Date

    September 1 2008

    Last Update

    May 17 2013

    Active Locations (7)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (7 locations)

    1

    British Columbia Cancer Agency - Centre for the Southern Interior

    Kelowna, British Columbia, Canada, V1Y 5L3

    2

    Fraser Valley Cancer Centre at British Columbia Cancer Agency

    Surrey, British Columbia, Canada, V3V 1Z2

    3

    British Columbia Cancer Agency - Vancouver Cancer Centre

    Vancouver, British Columbia, Canada, V5Z 4E6

    4

    Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre

    Halifax, Nova Scotia, Canada, B3H 1V7