Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Bethesda, Maryland 20892


Purpose:

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.


Study summary:

OBJECTIVES: - 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


Criteria:

DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed ocular melanoma - Metastatic disease confined to the liver - Limited sites of extrahepatic disease allowed, provided the dominant life-limiting disease is in the liver and the extrahepatic sites can be treated with local ablative measures (e.g., resection or external beam radiotherapy) - Measurable disease PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Platelet count greater than 75,000/mm^3 - Hematocrit greater than 27% - Absolute neutrophil count at least 1,500/mm^3 Hepatic - Bilirubin less than 2.0 mg/dL - PT no greater than 2 seconds above the upper limit of normal (ULN) - AST and ALT no greater than 10 times ULN - No biopsy proven cirrhosis - No evidence of significant portal hypertension by history, endoscopy, or radiologic study Renal - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance greater than 60 mL/min Cardiovascular - No history of congestive heart failure with LVEF less than 40% - No history of veno-occlusive disease Pulmonary - No chronic obstructive pulmonary disease - No other chronic pulmonary disease with pulmonary function tests less than 50% of predicted Other - Not pregnant or nursing - Negative pregnancy test - Weight greater than 30 kg - No active systemic infection - No prior hypersensitivity reaction to melphalan, dacarbazine, or temozolomide PRIOR CONCURRENT THERAPY: Biologic therapy - More than 28 days since prior biologic therapy for the malignancy Chemotherapy - More than 28 days since prior chemotherapy for the malignancy Endocrine therapy - Not specified Radiotherapy - More than 28 days since prior radiotherapy for the malignancy Surgery - Not specified Other - Recovered from all prior therapy - No concurrent chronic anticoagulation therapy - No concurrent immunosuppressive drugs


NCT ID:

NCT00066521


Primary Contact:

Study Chair
Steven K. Libutti, MD
NCI - Surgery Branch


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 18, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.