Clinical trial · Interventional
Interleukin-21 in Treating Patients With Metastatic or Recurrent Malignant Melanoma
A Phase II Study of Interleukin-21 (IL-21) in Patients With Metastatic or Recurrent Malignant Melanoma
NCT00514085CI-TRIAL-00068521completedPhase 2ClinicalTrials.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: Interleukin-21 may stimulate white blood cells, including natural killer cells, to kill melanoma cells. PURPOSE: This phase II trial is studying the side effects and how well interleukin-21 works in treating patients with metastatic or recurrent malignant melanoma.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
| recombinant human interleukin-21 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Recombinant human interleukin-21
- interventionNames
- Biological: recombinant human interleukin-21
- Other: immunohistochemistry staining method
- Other: laboratory biomarker analysis
- Other: pharmacological study
Primary outcomes (6)
- measure
- Objective tumor response as assessed by RECIST
- timeFrame
- after completion of treatment
- measure
- Overall response rate (complete and partial)
- timeFrame
- after completion of study
- measure
- Stable disease rate
- timeFrame
- after completion of study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed cutaneous malignant melanoma * Recurrent or metastatic disease that is not curable by surgical or other means * Clinically and/or radiologically documented disease defined as at least one site of disease unidimensionally measurable ≥ 20 mm by x-ray, physical exam, or nonspiral CT scan OR ≥ 10 mm by spiral CT scan * Must have nonbulky metastatic disease defined as the largest measurable lesion ≤ 50 mm in maximum diameter * Must have primary diagnosis tumor tissue or previously resected metastatic melanoma tissue available (i.e., paraffin block or unstained slides) * No known brain metastases PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy ≥ 12 weeks * Absolute granulocytes count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Bilirubin normal * Serum creatinine ≤ 1.5 times upper limit of normal (ULN) * AST and ALT ≤ 2.5 times ULN * Negative pregnancy test * Not pregnant or nursing * Fertile patients must use effective contraception during study therapy * No uncontrolled intercurrent illness or condition including, but not limited to, any of the following: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Psychiatric illness or social situation that would limit compliance with study requirements * No history of hemolysis or a hemolytic disorder including, but not limited to, any of the following: * Sickle cell anemia * Thalassemia * Autoimmune hemolytic anemia * No history of other malignancies within the past 5 years except adequately treated nonmelanoma skin cancer, curatively treated carcinoma in situ of the cervix, or other solid tumors curatively treated with no evidence of disease * No known HIV, hepatitis B, or hepatitis C infection * Patients must reside within a 2-hour drive from a participating center PRIOR CONCURRENT THERAPY: * No previous systemic therapy for metastatic disease * At least 3 months since prior adjuvant immunotherapy for recurrent melanoma * No prior immunotherapy for metastatic disease * No prior immunotherapy outside the adjuvant setting * At least 4 weeks since prior major surgery * At least 4 weeks since prior radiotherapy except low-dose, nonmyelosuppressive radiotherapy and recovered * More than 4 weeks since prior and no concurrent investigational agents or anticancer therapy * No prior chemotherapy including regional therapy * No concurrent systemic corticosteroids (e.g., prednisone or dexamethasone) * Concurrent topical steroids are allowed
References
Publications (1)
- RESULTPetrella TM, Tozer R, Belanger K, Savage KJ, Wong R, Smylie M, Kamel-Reid S, Tron V, Chen BE, Hunder NN, Hagerman L, Walsh W, Eisenhauer EA. Interleukin-21 has activity in patients with metastatic melanoma: a phase II study. J Clin Oncol. 2012 Sep 20;30(27):3396-401. doi: 10.1200/JCO.2011.40.0655. Epub 2012 Aug 20. PMID 22915661