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Clinical Protocol for Phase II Testing of ADI-PEG 20 in Patients With Metastatic Melanoma

Phase 2
18 Years
Not Enrolling
Melanoma (Skin)

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Trial Information

Clinical Protocol for Phase II Testing of ADI-PEG 20 in Patients With Metastatic Melanoma



- Determine the clinical response (complete and partial response) in patients with
unresectable metastatic melanoma treated with pegylated arginine deiminase.


- Determine the toxicity profile of this drug in these patients.

- Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.

- Determine the progression-free survival and overall survival of patients treated with
this drug.

OUTLINE: Patients receive pegylated arginine deiminase intramuscularly once or twice a week
in weeks 1-4. Courses repeat every 4 weeks for 6 courses in the absence of disease
progression or unacceptable toxicity.

Blood samples are acquired at baseline and every 2 weeks thereafter for pharmacokinetic and
pharmacodynamic studies.

After completion of study treatment, patients are followed every 3 months for 1 year, every
6 months for 5 years, and annually thereafter.

PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.

Inclusion Criteria


- Histologically confirmed metastatic melanoma, meeting any of the following criteria:

- Progressive disease after chemotherapy, radiotherapy, surgery, or immunotherapy

- No longer responding to standard therapy OR have refused standard therapy

- Unresectable disease

- Measurable or evaluable disease

- No clinical ascites

- No symptomatic pleural effusion


- Life expectancy ≥ 12 weeks

- Karnofsky performance status 70-100%

- Bilirubin ≤ 3.0 mg/dL

- Albumin ≥ 3.0 g/dL

- Alkaline phosphatase < 5 times upper limit of normal (ULN)

- Serum glucose > 60 mg/dL

- Amylase < 1.5 times ULN

- Absolute neutrophil count > 1,500/mm³

- Platelet count > 100,000/mm³

- No New York Heart Association class III-IV heart failure

- No serious infection requiring treatment with antibiotics

- No known allergy to E. coli drug products (e.g., sargramostim [GM-CSF])

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use 2 forms of effective contraception


- See Disease Characteristics

- At least 4 weeks since prior anticancer therapy

- At least 4 weeks since prior surgery and recovered

- No concurrent participation in another investigational drug study

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rate (Partial and Complete Response) in Patients With or Without ASS Expression Present in Tumor.

Outcome Description:

Response rate is defined as a partial response, PR, and complete response, CR, lasting for at least 30 days per RECIST criteria, v. 1.0. Complete response will be defined as disappearance of all target lesions. Partial response will be defined as at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference the baseline sum of LD

Outcome Time Frame:

Up to 16 months

Safety Issue:


Principal Investigator

Lynn G. Feun, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Miami Sylvester Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

June 2004

Completion Date:

February 2012

Related Keywords:

  • Melanoma (Skin)
  • recurrent melanoma
  • stage IV melanoma
  • Melanoma



University of Miami Sylvester Comprehensive Cancer Center - MiamiMiami, Florida  33136