Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

Isolated Hepatic (Liver) Perfusion With Melphalan Followed By Temozolomide in Treating Patients With Unresectable Liver Metastases from Ocular (Eye) Melanoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	NCI-03-C-0221 NCT00066521

Special Category: NCI Web site featured trial

Objectives

1. 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.
2. Determine the pattern of recurrence in patients treated with this regimen.
3. Determine the disease-free and overall survival of patients treated with this regimen.
4. Determine the quality of life of patients treated with this regimen.

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Platelet count greater than 75,000/mm³
• Hematocrit greater than 27%
• Absolute neutrophil count at least 1,500/mm³

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

Expected Enrollment

A total of 9-40 patients will be accrued for this study

Outcomes

Percentage of responders with response duration > 6 months

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.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Steven Libutti, MD, Protocol chair		Ph: 301-496-5049 Email: steven_Libutti@nih.gov

Related Information

Featured trial article

Registry Information
Official Title		A Phase II Study of Isolated Hepatic Perfusion (IHP) with Melphalan Followed by Temozolomide for Subjects with Unresectable Hepatic Metastases from Ocular Melanoma
Trial Start Date		2003-06-18
Trial Completion Date		2008-01-25
Registered in ClinicalTrials.gov		NCT00066521
Date Submitted to PDQ		2003-06-18
Information Last Verified		2008-02-04

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