Clinical trial · Interventional
Vaccine Therapy With High-Dose Interleukin-2 in Treating Patients With Metastatic Melanoma
A Randomized Phase II Trial of a Mutated gp100 Melanoma Peptide (g209-217(210M) With Hight Dose Interleukin-2 (IL-2) in HLA-A2.1+Patients With Metastatic Melanoma
NCT00003568CI-TRIAL-00011076completedPhase 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: Vaccines may make the body build an immune response that will kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy with interleukin-2 in treating patients with metastatic 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
| gp100 antigen | Biological | — | UNRESOLVED |
| incomplete Freund's adjuvant | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed clearly progressive metastatic or unresectable melanoma * Must be HLA-A2.1 positive * Measurable disease * No active brain metastases, leptomeningeal disease, or seizure disorder * More than 4 months since prior definitive therapy (surgery or radiotherapy) for brain metastases and must not have evidence of disease on brain CT scan or MRI * No ascites or pleural effusions PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-1 OR * Karnofsky 80-100% Life expectancy: * Not specified Hematopoietic: * WBC at least 3,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9 g/dL Hepatic: * Bilirubin no greater than 2.0 mg/dL Renal: * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance at least 60 mL/min Cardiovascular: * No congestive heart failure * No symptoms of coronary artery disease * No serious cardiac arrhythmias * No evidence of prior myocardial infarction on EKG * Normal cardiac stress test required for all patients over 40 years Pulmonary: * FEV\_1 greater than 2.0 liters or at least 75% of predicted * No chronic obstructive pulmonary disease Other: * HIV negative * No significant systemic infection * No contraindication to use of pressor agents * No history of major psychiatric illness * No other major illness that would significantly increase the risk of immunotherapy * No other active malignancy except surgically cured nonmelanoma skin cancer or carcinoma in situ or stage I carcinoma of the cervix * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior interleukin-2 * At least 4 weeks since prior vaccine therapy or other cytokine therapy Chemotherapy: * One prior chemotherapy regimen allowed * At least 4 weeks since prior chemotherapy (6 weeks for carmustine or lomustine) and recovered Endocrine therapy: * No concurrent steroids Radiotherapy: * See Disease Characteristics * No prior radiotherapy to areas of measurable disease unless there has been clearly progressive disease in this site or there is measurable disease outside of areas of prior radiation * At least 2 weeks since prior radiotherapy for local control or palliative therapy and recovered Surgery: * See Disease Characteristics * Recovered from prior major surgery * No prior organ allografts Other: * No antihypertensive therapy within 24 hours prior to interleukin-2
References
Publications (0)
Data not yet available
No reference posted for this study.