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A Random-Assignment Study of Hepatic Arterial Infusion of Melphalan With Venous Filtration Via Peripheral Hepatic Perfusion (PHP) (Delcath System) Versus Best Alternative Care for Ocular and Cutaneous Melanoma Metastatic to the Liver


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Intraocular Melanoma, Melanoma (Skin), Metastatic Cancer

Thank you

Trial Information

A Random-Assignment Study of Hepatic Arterial Infusion of Melphalan With Venous Filtration Via Peripheral Hepatic Perfusion (PHP) (Delcath System) Versus Best Alternative Care for Ocular and Cutaneous Melanoma Metastatic to the Liver


OBJECTIVES:

Primary

- Compare the hepatic progression-free survival of patients with unresectable liver
metastases secondary to ocular or cutaneous melanoma treated with percutaneous isolated
hepatic arterial perfusion (PHP) with melphalan with subsequent venous hemofiltration
vs the best alternative standard treatment.

Secondary

- Determine the response rate and duration of response in patients treated with melphalan
PHP.

- Determine the patterns of recurrence in patients treated with melphalan PHP.

- Compare the overall survival of patients treated with these regimens.

- Compare the safety and tolerability of these regimens in these patients.

- Determine the pharmacokinetics of melphalan after PHP.

OUTLINE: This is a multicenter study. Patients are stratified according to site of disease
(ocular vs cutaneous). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients undergo an isolated hepatic arterial infusion of melphalan over 30
minutes on day 1. Treatment repeats every 4 weeks for 4 courses in the absence of
disease progression or unacceptable toxicity. Patients with complete or partial
response undergo 2 additional courses in the absence of ongoing or increasing toxicity.

- Arm II: Patients receive the best alternative therapy comprising supportive care,
systemic or regional chemotherapy, hepatic artery (chemo)-embolization, or any other
appropriate therapy at the National Cancer Institute or therapy at the discretion of
their physician. Patients may cross over to arm I if they have evidence of disease
progression.

Blood samples are collected periodically for pharmacokinetic analysis of melphalan.

After completion of study treatment, patients are followed periodically for 4 years and then
annually for survival.

PROJECTED ACCRUAL: A total of 92 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed liver metastases secondary to cutaneous or
ocular melanoma

- Unresectable disease

- Predominantly in the parenchyma of the liver

- Measurable disease by CT scan and/or MRI

- Limited unresectable extrahepatic disease allowed provided the life-limiting
component of progressive disease is in the liver, including, but not limited to, any
of the following:

- Up to 4 pulmonary nodules, each < 1 cm in diameter

- Retroperitoneal lymph nodes < 3 cm in diameter

- Less than 10 skin or subcutaneous metastases < 1 cm in diameter

- Asymptomatic bone metastases that are eligible for or have undergone palliative
external-beam radiotherapy

- Solitary metastasis to any site that can be resected

PATIENT CHARACTERISTICS:

- Life expectancy ≥ 3 months

- ECOG performance status 0-2

- Bilirubin < 3.0 mg/dL

- PT within 2 seconds of upper limit of normal (ULN)

- AST/ALT ≤ 10 times ULN

- Platelet count > 75,000/mm^3

- Hematocrit > 27% (may be achieved with a transfusion)

- Absolute neutrophil count ≥ 1,300/mm^3

- Creatinine ≤ 1.5 mg/dL OR creatinine clearance > 60 mL/min

- Fertile patients must use effective contraception

- Not pregnant or nursing

- Negative pregnancy test

- No history of congestive heart failure

- LVEF ≥ 40%

- No significant chronic obstructive pulmonary disease (COPD) or other chronic
pulmonary restrictive disease

- FEV_1 ≥ 30%

- DLCO ≥ 40% of predicted

- Weight ≥ 35 kg

- No untreated active bacterial infection with systemic manifestations (e.g., malaise,
fever, and leucocytosis)

- No severe allergic reactions to iodine contrast unless reaction can be controlled by
antihistamines and/or steroids

- No known hypersensitivity to melphalan

- No positive serology for HIV, hepatitis B surface antigen, or hepatitis C antibody
(pharmacokinetics portion of the study only)

- No known latex allergy

- No Childs B or C cirrhosis

- No evidence of portal hypertension by history, endoscopy, or radiological study

- No prior history of gastrinoma

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- At least 1 month since prior chemotherapy, radiotherapy, or biologic therapy for this
cancer and recovered

- No prior regionally delivered melphalan

- No prior Whipple procedure

- No concurrent immunosuppressive therapy

- No concurrent chronic anticoagulation therapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Safety Issue:

No

Principal Investigator

Marybeth S. Hughes, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

NCI - Surgery Branch

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000468944

NCT ID:

NCT00324727

Start Date:

February 2006

Completion Date:

Related Keywords:

  • Intraocular Melanoma
  • Melanoma (Skin)
  • Metastatic Cancer
  • liver metastases
  • extraocular extension melanoma
  • stage IV melanoma
  • recurrent melanoma
  • recurrent intraocular melanoma
  • metastatic intraocular melanoma
  • iris melanoma
  • ciliary body and choroid melanoma, medium/large size
  • Melanoma
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Uveal Neoplasms

Name

Location

Cancer Center of Albany Medical CenterAlbany, New York  12208
Swedish Medical CenterEnglewood, Colorado  80110
University of Texas Medical BranchGalveston, Texas  77555-1329
Carol G. Simon Cancer Center at Morristown Memorial HospitalMorristown, New Jersey  07962
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical CenterColumbus, Ohio  43210-1240
UPMC Cancer CentersPittsburgh, Pennsylvania  15232
Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon  97213-2967
H. Lee Moffitt Cancer Center and Research Institute at University of South FloridaTampa, Florida  33612
St. Luke's Cancer Network at St. Luke's HospitalBethlehem, Pennsylvania  18015
John Wayne Cancer Institute at Saint John's Health CenterSanta Monica, California  90404
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral OfficeBethesda, Maryland  20892-1182