Isolated Hepatic (Liver) Perfusion With Melphalan Followed By Temozolomide in Treating Patients With Unresectable Liver Metastases From Ocular (Eye) Melanoma - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00066521

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.

Condition	Intervention	Phase
Intraocular Melanoma Metastatic Cancer	Drug: isolated perfusion Drug: melphalan Drug: temozolomide Procedure: adjuvant therapy	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
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

Resource links provided by NLM:

Genetics Home Reference related topics: retinoblastoma

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Temozolomide Melphalan Sarcolysin Melphalan hydrochloride

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Percentage of responders with response duration > 6 months [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	June 2003
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00066521

Locations

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair:

Steven K. Libutti, MD

NCI - Surgery Branch

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Featured trial article This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000316262, NCI-03-C-0221
Study First Received:	August 6, 2003
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00066521 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

liver metastases
recurrent intraocular melanoma
metastatic intraocular melanoma
extraocular extension melanoma

Additional relevant MeSH terms:

Melphalan
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Melanoma
Neoplastic Processes
Neoplasms by Site
Pathologic Processes
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Neoplasm Metastasis

Nevi and Melanomas
Alkylating Agents
Neoplasms by Histologic Type
Eye Neoplasms
Eye Diseases
Temozolomide
Immunosuppressive Agents
Pharmacologic Actions
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms
Myeloablative Agonists
Antineoplastic Agents, Alkylating

ClinicalTrials.gov processed this record on November 05, 2009