Full Text View
Tabular View
No Study Results Posted
Related Studies
Isolated Hepatic (Liver) Perfusion With Melphalan Followed By Temozolomide in Treating Patients With Unresectable Liver Metastases From Ocular (Eye) Melanoma
This study has been completed.
Study NCT00066521   Information provided by National Cancer Institute (NCI)
First Received: August 6, 2003   Last Updated: February 6, 2009   History of Changes

August 6, 2003
February 6, 2009
June 2003
January 2008   (final data collection date for primary outcome measure)
Percentage of responders with response duration > 6 months [ Designated as safety issue: No ]
Percentage of responders with response duration > 6 months
Complete list of historical versions of study NCT00066521 on ClinicalTrials.gov Archive Site
 
 
 
Isolated Hepatic (Liver) Perfusion With Melphalan Followed By Temozolomide in Treating Patients With Unresectable Liver Metastases From Ocular (Eye) Melanoma
A Phase II Study of Isolated Hepatic Perfusion (IHP) With Melphalan Followed by Temozolomide for Subjects With Unresectable Hepatic Metastases From Ocular Melanoma

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.

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

Phase II
Interventional
Treatment, Open Label
  • Intraocular Melanoma
  • Metastatic Cancer
  • Drug: isolated perfusion
  • Drug: melphalan
  • Drug: temozolomide
  • Procedure: adjuvant therapy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
40
 
January 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00066521
 
CDR0000316262, NCI-03-C-0221
National Cancer Institute (NCI)
 
Study Chair: Steven K. Libutti, MD NCI - Surgery Branch
National Cancer Institute (NCI)
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP