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Imatinib Mesylate in Treating Patients With Metastatic Melanoma
This study has been suspended.
First Received: December 7, 2001   Last Updated: April 7, 2009   History of Changes
Sponsor: M.D. Anderson Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00027586
  Purpose

RATIONALE: Imatinib mesylate may interfere with the growth of tumor cells and may be an effective treatment for metastatic melanoma.

PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have metastatic melanoma.


Condition Intervention Phase
Melanoma (Skin)
Drug: imatinib mesylate
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Trial of Gleevec (Imatinib Mesylate, STI-571) in Metastatic Melanoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Response rate [ Designated as safety issue: No ]

Study Start Date: September 2001
Detailed Description:

OBJECTIVES:

  • Determine the clinical activity of imatinib mesylate (STI571) in patients with metastatic melanoma.
  • Determine the side effects of this drug in these patients.
  • Correlate molecular studies with responsiveness to this drug in these patients.

OUTLINE: Patients receive oral imatinib mesylate (STI571) twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 21-78 patients will be accrued for this study within 6-15 months.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed melanoma
  • At least 20% of tumor cells with 1 of the following by immunohistochemistry:

    • Platelet-derived growth factor receptor alpha or beta
    • KIT (CD 117) expression documented by DAKO antibody staining c-abl, ARG
  • At least 1 unidimensionally measurable metastatic target lesion, defined by 1 of the following:

    • At least 20 mm by conventional techniques
    • At least 10 mm by spiral CT scan
    • At least 10 mm for obviously visible cutaneous tumors
  • Target lesions that have been previously embolized, perfused, or irradiated must have evidence of progression
  • At least 1 metastatic lesion other than target lesion in subcutaneous site or lymph node that can be biopsied
  • No symptomatic CNS metastases

    • Small asymptomatic CNS metastases allowed if no requirement for steroids exists and there is no associated significant edema
  • No brain metastases as only site of disease

PATIENT CHARACTERISTICS:

Age:

  • Any age

Performance status:

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9 g/dL (transfusion allowed)

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST/ALT no greater than 2.5 times ULN
  • No uncontrolled chronic liver disease

Renal:

  • Creatinine no greater than 1.5 times ULN
  • No uncontrolled chronic renal disease

Cardiovascular:

  • No symptomatic congestive heart failure
  • No myocardial infarction within the past 2 months
  • No unstable angina pectoris
  • No cardiac arrhythmia

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for 3 months after study entry
  • No other concurrent severe and/or uncontrolled illness (e.g., uncontrolled diabetes)
  • No active uncontrolled infection
  • No psychiatric illness, social situation, or medical condition that would preclude study participation
  • No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other stage I or II cancer in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior biologic therapy
  • Prior interferon therapy and/or one other systemic therapy regimen (e.g., chemotherapy, biotherapy, or biochemotherapy) allowed

    • Active immunotherapy (e.g., cancer vaccines) not included as systemic therapy regimen
  • No concurrent anticancer biologic agents

Chemotherapy:

  • See Biologic therapy
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
  • No concurrent chemotherapy

Endocrine therapy:

  • See Disease Characteristics

Radiotherapy:

  • See Disease Characteristics
  • No concurrent radiotherapy

Surgery:

  • At least 2 weeks since prior surgery

Other:

  • Recovered from any prior therapy
  • At least 28 days since prior investigational drugs
  • No other concurrent anticancer agents
  • No other concurrent investigational (i.e., non-approved) drugs
  • No concurrent therapeutic doses of warfarin as anticoagulation therapy
  • Concurrent therapeutic low-molecular weight heparin or other agents allowed
  • Concurrent mini-dose warfarin (1 mg/day) as prophylaxis allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00027586

Locations
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Kevin Kim, MD M.D. Anderson Cancer Center
Investigator: Menashe Bar-Eli, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000069045, MDA-ID-01284, NCI-5345
Study First Received: December 7, 2001
Last Updated: April 7, 2009
ClinicalTrials.gov Identifier: NCT00027586     History of Changes
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on November 27, 2009