Full Text View
Tabular View
No Study Results Posted
Related Studies
Dasatinib in Treating Patients With Stage III Melanoma That Cannot Be Removed By Surgery or Stage IV Melanoma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), April 2008
First Received: February 15, 2007   Last Updated: April 14, 2009   History of Changes
Sponsors and Collaborators: Yale University
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00436605
  Purpose

RATIONALE: Dasatinib 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 dasatinib works in treating patients with stage III melanoma that cannot be removed by surgery or stage IV melanoma.


Condition Intervention Phase
Melanoma (Skin)
Drug: dasatinib
Phase II

MedlinePlus related topics: Cancer Melanoma Surgery
Drug Information available for: Dasatinib
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: A Phase 2 Study of Dasatinib in Advanced Melanoma

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

Primary Outcome Measures:
  • Objective response rate (partial response and complete response) as measured by RECIST criteria [ Designated as safety issue: No ]
  • Progression-free survival at 6 months [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: December 2006
Estimated Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the objective response rate in patients with stage III unresectable or stage IV melanoma treated with dasatinib.
  • Determine the progression-free survival of patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for 4 weeks.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage III unresectable or stage IV melanoma
  • Measurable disease
  • Must have evidence of tumor growth or new lesions within the past 6 months
  • No large pleural effusions
  • No known brain metastases or leptomeningeal metastases

    • Previously treated brain metastases allowed provided there is no requirement for steroids AND no evidence of progression for ≥ 8 weeks after treatment

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
  • Life expectancy > 3 months
  • WBC ≥ 3,000/mm³
  • Absolute neutrophil count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Hemoglobin ≥ 9.0 g/dL (transfusions allowed)
  • Bilirubin ≤ 1.5 mg/mL
  • AST and ALT ≤ 2.5 times upper limit of normal (ULN)
  • PT/INR and PTT normal
  • Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
  • No medical condition that may affect the ability to swallow and retain dasatinib tablets, including any of the following:

    • Gastrointestinal tract disease resulting in an inability to take oral medication
    • Requirement for IV alimentation
    • Prior surgical procedures affecting absorption
    • Active peptic ulcer disease
  • No clinically significant cardiovascular disease, including any of the following:

    • Myocardial infarction or ventricular tachyarrhythmia within the past 6 months
    • Prolonged QTc > 480 msec
    • Major conduction abnormality (unless a cardiac pacemaker is present)
  • No uncontrolled intercurrent illness including, but not limited to, any of the following:

    • Ongoing or active infection
    • History of significant congenital or acquired bleeding disorder, including any of the following:

      • Von Willebrand's disease
      • Antifactor VIII antibodies
    • Dyspnea at rest or with minimal exertion
    • Uncontrolled seizure disorder
    • Psychiatric illness or social situations that would preclude study compliance
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other active malignancy within the past 3 years except curatively treated stage I malignancies or resected skin carcinomas

PRIOR CONCURRENT THERAPY:

  • Recovered from prior therapy
  • Prior adjuvant therapy for stage II or III melanoma allowed
  • No prior cytotoxic therapy for metastatic melanoma
  • No prior dasatinib or other inhibitors of src, bcr-abl, c-Kit, EPHA2, and PDGFRβ
  • No more than 2 prior immunomodulator therapies for metastatic melanoma
  • At least 1 week since prior and no concurrent warfarin or other anticoagulants or medications that inhibit platelet function (including acetylsalicylic acid)
  • At least 1 week since prior and no concurrent steroids or other immunosuppressive agents

    • Concurrent steroids to treat induced pleural effusions allowed
  • At least 3 weeks since prior immunomodulators including, but not limited to, any of the following:

    • Aldesleukin
    • Cancer vaccines
    • T-cell-activating monoclonal antibodies
  • At least 4 weeks since prior radiotherapy

    • Prior palliative radiotherapy to a single site of disease allowed (tumor is not considered evaluable for response unless there is tumor progression at the site of radiation)
  • More than 7 days since prior and no concurrent CYP3A4 inhibitors
  • At least 7 days since prior and no concurrent agents with proarrhythmic potential
  • No other concurrent investigational agents
  • No other concurrent anticancer agents or therapies
  • No concurrent enzyme-inducing anticonvulsant agents
  • No concurrent grapefruit or grapefruit juice
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent CYP3A4 inducers
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00436605

Locations
United States, Connecticut
Yale Cancer Center Recruiting
New Haven, Connecticut, United States, 06520-8028
Contact: Clinical Trials Office - Yale Cancer Center     203-785-5702        
United States, Minnesota
Masonic Cancer Center at University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Clinical Trials Office - Masonic Cancer Center at University o     612-624-2620        
Sponsors and Collaborators
Yale University
Investigators
Study Chair: Harriet Kluger, MD Yale University
  More Information

Additional Information:
No publications provided

Responsible Party: Yale Cancer Center ( Harriet Kluger )
Study ID Numbers: CDR0000528937, YALE-HIC-0608001765, UMN-2007UC009
Study First Received: February 15, 2007
Last Updated: April 14, 2009
ClinicalTrials.gov Identifier: NCT00436605     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage III melanoma
stage IV melanoma
recurrent melanoma

Study placed in the following topic categories:
Neuroectodermal Tumors
Dasatinib
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Nevus
Protein Kinase Inhibitors
Recurrence
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Neoplasms, Nerve Tissue
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms
Neoplasms, Germ Cell and Embryonal
Dasatinib
Nevi and Melanomas

ClinicalTrials.gov processed this record on May 07, 2009