Clinical trial NCT00450372: Pegylated Arginine Deiminase in Treating Patients With Metastatic Melanoma That Cannot Be Removed by Surgery
Official title: Clinical Protocol for Phase II Testing of ADI-PEG 20 in Patients With Metastatic Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Melanoma (Skin)
Keywords: recurrent melanoma
stage IV melanoma
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2007-03-22
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RATIONALE: Pegylated arginine deiminase may stop the growth of tumor cells by taking away an amino acid needed for cell growth.

PURPOSE: This phase II trial is studying how well pegylated arginine deiminase works in treating patients with metastatic melanoma that cannot be removed by surgery.

Detailed description: OBJECTIVES:

Primary:

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

Secondary:

* 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.

Eligibility criteria: DISEASE CHARACTERISTICS:

* 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

PATIENT CHARACTERISTICS:

* 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

PRIOR CONCURRENT THERAPY:

* 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

Primary outcomes:
measure: Response Rate (Partial and Complete Response) in Patients With or Without ASS Expression Present in Tumor.
timeFrame: Up to 16 months
Secondary outcomes:
measure: Median Overall Survival
timeFrame: Up to 16 months
measure: Median Time to Progression
timeFrame: Up to 16 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Sylvester Comprehensive Cancer Center - Miami
state: Florida
Study officials:
affiliation: University of Miami Sylvester Comprehensive Cancer Center
name: Lynn G. Feun, MD
role: STUDY_CHAIR
References:
citation: Feun LG, Marini A, Walker G, Elgart G, Moffat F, Rodgers SE, Wu CJ, You M, Wangpaichitr M, Kuo MT, Sisson W, Jungbluth AA, Bomalaski J, Savaraj N. Negative argininosuccinate synthetase expression in melanoma tumours may predict clinical benefit from arginine-depleting therapy with pegylated arginine deiminase. Br J Cancer. 2012 Apr 24;106(9):1481-5. doi: 10.1038/bjc.2012.106.