Clinical trial · Interventional
ADI-PEG in Patients With Metastatic Melanoma
Phase I Testing of ADI-PEG in Metastatic Melanoma
NCT00029900CI-TRIAL-00017230completedPhase 1ClinicalTrials.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)
This is a study to determine the safety and toxicity of increasing doses of arginine deiminase combined to polyethylene glycol (ADI-PEG) in patients with nonresectable metastatic melanoma.
Conditions
Conditions (2)
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 | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Neoplasm Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ADI PEG | Drug | Pegargiminase | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion criteria: * Histologically confirmed metastatic melanoma * Nonresectable disease * Measurable or evaluable disease * Progressive disease following standard chemotherapy, radiotherapy, surgery, or immunotherapy; and no longer responding to therapy * Recovered from prior surgery * Karnofsky performance status 70 or higher * Expected survival of at least 12 weeks * Bilirubin less than 2.0 mg/dL * Albumin greater than 3.0 g/dL * SGOT less than 5 times upper limit of normal (ULN) * Alkaline phosphatase less than 5 times ULN * Ammonia less than 55 microg/dL * Glucose greater than 60 mg/dL * Amylase less than 1.5 times ULN * Absolute neutrophil count greater than 1,500/mm3 * Platelet count greater than 100,000/mm3 * Patients must use 2 forms of effective contraception Exclusion criteria: * Prior therapy within the past 4 weeks * Ascites or pleural effusion * Significant cardiac disease (i.e., New York Heart Association class III or IV heart disease) * Pregnant or nursing * Concurrent enrollment in another IND study * Serious infection requiring antibiotics
References
Publications (0)
Data not yet available
No reference posted for this study.