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Status:

COMPLETED

Sorafenib in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed By Surgery

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Stage III Melanoma

Stage IV Melanoma

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. This phase II trial is studying how well sorafenib works in...

Detailed Description

PRIMARY OBJECTIVES: I. Determine the efficacy of sorafenib, in terms of anti-tumor effects and proportion of clinical responses, in patients with previously untreated unresectable stage III or stage ...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Histologically or cytologically confirmed unresectable melanoma
  • Stage III or IV disease
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion \> 20 mm by conventional techniques OR \> 10 mm by spiral CT scan
  • Disease amenable to biopsy (first 13 patients in each stratum only)
  • Brain metastases allowed provided the following criteria are met:
  • Disease has remained radiologically stable for ≥ 6 weeks after completion of whole-brain radiotherapy and remains stable at the time of study entry
  • No mass effect present by radiology
  • No requirement for steroid therapy to control symptoms of brain metastases
  • Performance status - ECOG 0-2
  • Performance status - Karnofsky 60-100%
  • At least 3 months
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • No evidence of bleeding diathesis
  • AST and ALT ≤ 2.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 2 times ULN
  • Creatinine ≤ 1.5 times ULN
  • No uncontrolled hypertension
  • 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 psychiatric illness that would preclude study compliance
  • No pre-existing non-hematological dysfunction ≥ grade 2
  • No ongoing or active infection
  • No history of serious allergic reaction to eggs
  • Able to swallow pills
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or other non-invasive carcinoma
  • No other uncontrolled illness
  • Not specified
  • No prior systemic chemotherapy for metastatic disease
  • See Disease Characteristics
  • See Disease Characteristics
  • No other concurrent investigational agents
  • No concurrent therapeutic anticoagulation
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent anticancer therapy

Exclusion

    Key Trial Info

    Start Date :

    June 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    74 Patients enrolled

    Trial Details

    Trial ID

    NCT00119249

    Start Date

    June 1 2005

    Last Update

    January 15 2013

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Montefiore Medical Center

    The Bronx, New York, United States, 10467-2490