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View Clinical Trial (Medical Research Study)
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Dasatinib in Treating Patients With Locally Advanced or Metastatic Mucosal Melanoma, Acral Melanoma, or Solar Melanoma That Cannot Be Removed By Surgery - NCT00700882-54601 (Clinical Trial 228178)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy228178.aspx
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| City: |
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La Crosse |
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State:
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WI |
| Zip Code: |
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54601 |
| Conditions: |
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Melanoma (Skin) |
| Purpose: |
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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
locally advanced or metastatic mucosal melanoma, acral melanoma, or solar melanoma that
cannot be removed by surgery.
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| Study summary: |
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OBJECTIVES:
Primary
- To estimate the objective tumor response rate in patients with unresectable locally
advanced or metastatic acral, mucosal, or solar melanoma treated with dasatinib
monotherapy.
Secondary
- To estimate the response duration in patients treated with this drug.
- To estimate the progression-free survival of patients treated with this drug.
- To evaluate the safety profile of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral dasatinib twice daily on days 1-21. Courses repeat every 21 days in
the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed periodically for up to 5 years. |
| Criteria: |
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DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed melanoma of 1 of the following subtypes:
- Acral melanoma (defined as occurring on the palms, soles, or subungual sites)
- Mucosal melanoma (defined as arising on surfaces of the body such as the mouth,
sinuses, rectum, or vagina)
- Cutaneous melanoma with chronic sun damage (defined as the presence of solar
elastosis in the skin adjacent to the melanoma)
- Primary tumor blocks are required to confirm the presence of solar
elastosis
- Unresectable locally advanced or metastatic disease
- Metastatic tumor blocks are required for the evaluation of KIT mutations or
amplifications
- Measurable disease, defined as at least one measurable lesion by RECIST criteria
- Prior radiotherapy to a measurable lesion allowed provided there is radiographic
evidence of progression of that lesion
- No ocular melanoma
- Baseline bone scan required for patients with known bone metastases, elevated
alkaline phosphatase, or symptoms raising suspicion of bone metastases
- History or clinical evidence of brain metastasis allowed provided the following
criteria are met:
- Completed radiotherapy or surgical treatment of brain lesions AND there is no
evidence of CNS progression for ≥ 8 weeks
- Must not require corticosteroids for treatment of cerebral edema from brain
metastases
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- WBC ≥ 3,000/mm³
- Absolute granulocyte count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Creatinine ≤ 2.0 times upper limit of normal (ULN) OR creatinine clearance ≥ 40
mL/min
- Total bilirubin ≤ 1.5 times ULN (< 3.0 times ULN in the presence of Gilbert's
disease)
- AST and ALT ≤ 2.5 times ULN (≤ 5.0 times ULN in the presence of liver metastases)
- Serum potassium and magnesium normal (repletion allowed)
- Total serum calcium or ionized calcium normal
- INR ≤ 1.5 and PTT normal
- Therapeutic anticoagulation with warfarin allowed provided INR ≤ 1.5 or PTT
normal prior to initiating anticoagulation therapy
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No evidence of bleeding diathesis
- No other malignancies except basal cell or squamous cell skin cancer, carcinoma in
situ of the cervix, ductal or lobular carcinoma in situ of the breast, or other
malignancies from which the patient has been continuously disease-free for ≥ 5 years
- No clinically significant cardiovascular disease (i.e., myocardial infarction or
unstable angina), New York Heart Association class II-IV congestive heart failure,
ventricular arrhythmia requiring medication, or peripheral vascular disease ≥ grade 2
within the past year
- No uncontrolled hypertension, defined as systolic blood pressure ≥ 150 mm Hg or
diastolic blood pressure ≥ 90 mm Hg
- Hypertension that is adequately controlled with medication allowed
- No QTc prolongation, defined as a QTc interval ≥ 450 msecs
- No concurrent serious illness including, but not limited to, ongoing or active
infection requiring parenteral antibiotics
- No psychiatric illness or social situation that would limit compliance with study
requirements
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Recovered from prior therapy
- No prior treatment with targeted therapies directed to C-KIT/PDGFR (e.g., imatinib
mesylate or sunitinib malate)
- Prior limb perfusion allowed
- Prior systemic therapy allowed
- At least 4 weeks since prior chemotherapy or immunotherapy
- Prior adjuvant or neoadjuvant chemotherapy or immunotherapy allowed
- At least 4 weeks since prior radiotherapy
- No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (i.e., phenytoin,
carbamazepine, or phenobarbital), rifampin, or Hypericum perforatum (St. John's wort) |
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| Study is available at: |
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Gundersen Lutheran Center for Cancer and Blood
La Crosse, WI 54601
United States
Primary Contact:
Clinical Trials Office - Gundersen Lutheran Cancer Center
Email: cancerctr@gundluth.org
Phone: 608-775-2385 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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