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Home > "I" Clinical Trials Conditions > Imatinib Mesylate in Treating Patients With Metastatic Melanoma  Imatinib Mesylate in Treating Patients With Metastatic Melanoma
Imatinib Mesylate in Treating Patients With Metastatic Melanoma
For Condition: Stage 4 Melanoma,Recurrent Melanoma
Status: Suspended
Sponsor(s): M.D. Anderson Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
OmarEton, Study Chair, M.D. Anderson Cancer Center
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Additional Information:
Study ID Numbers: CDR0000069045; NCI-5345,MDA-ID-01284
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00027586
Other Recurrent Melanoma Studies:
1. Photodynamic Therapy in Treating Patients With Stage III or Stage IV Melanoma
2. Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Small Cell Lung, Breast, Testicular, or Kidney Cancer That is Metastatic or That Cannot Be Treated With Surgery
3. Chemotherapy Plus Bone Marrow Transplantation in Treating Patients With Metastatic Melanoma
4. Carboplatin and Temozolomide in Treating Patients With Unresectable or Metastatic Melanoma
5. Vaccine Therapy in Treating Patients With Stage IV or Recurrent Melanoma
Related Studies:
Other Recurrent Melanoma Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Imatinib Mesylate in Treating Patients With Metastatic Melanoma
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