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RATIONALE: Drugs used in chemotherapy such as melphalan and temozolomide use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs in different ways may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of isolated hepatic (liver) perfusion with melphalan followed by temozolomide in treating patients who have unresectable liver metastases that has resulted from ocular (eye) melanoma.
- Determine the response rate and duration of response in patients with unresectable hepatic metastases secondary to ocular melanoma treated with isolated hepatic perfusion with melphalan followed by temozolomide.
- Determine the pattern of recurrence in patients treated with this regimen.
- Determine the disease-free and overall survival of patients treated with this regimen.
- Determine the quality of life of patients treated with this regimen.
OUTLINE: Patients who are otherwise eligible undergo exploration through a limited incision. Patients with peritoneal seeding or unresectable extrahepatic metastatic disease are removed from study. All other patients undergo isolated hepatic perfusion (IHP) and receive melphalan intra-arterially over 1 hour.
Within 8-12 weeks after IHP, patients are re-evaluated by MRI. Patients with stable or responding disease receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, 8-12 weeks after IHP, every 3 months during temozolomide, and at all follow-up visits.
Patients are followed every 3 months for 2 years and then every 4 months thereafter.
PROJECTED ACCRUAL: A total of 9-40 patients will be accrued for this study
Masking: Open Label, Primary Purpose: Treatment
isolated perfusion, melphalan, temozolomide, adjuvant therapy
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-07-24T14:33:39-0400
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