Clinical trial · Interventional
Pegylated Arginine Deiminase in Treating Patients With Metastatic Melanoma That Cannot Be Removed by Surgery
Clinical Protocol for Phase II Testing of ADI-PEG 20 in Patients With Metastatic Melanoma
NCT00450372CI-TRIAL-00025867completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ADI-PEG-20 | Biological | Pegargiminase | ALIAS |
| Pharmacology Studies | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ADI-PEG 20
- interventionNames
- Biological: ADI-PEG-20
- Other: Pharmacology Studies
Primary outcomes (1)
- measure
- Response Rate (Partial and Complete Response) in Patients With or Without ASS Expression Present in Tumor.
- timeFrame
- Up to 16 months
- 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
Secondary outcomes (2)
- measure
- Median Overall Survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTFeun 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. PMID 22472884