Clinical trial · Interventional
Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma
Treatment of Patients With Metastatic Melanoma Using Cloned Peripheral Blood Lymphocytes Sensitized In Vitro to the gp209-2M Immunodominant Peptide
NCT00019487CI-TRIAL-00010881completedPhase 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 made from a person's white blood cells may make the body build an immune response and kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma that has not responded to previous therapy.
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 |
| gp209-2M antigen | Biological | — | UNRESOLVED |
| incomplete Freund's adjuvant | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven metastatic melanoma that has failed therapy on protocols involving immunization against the gp100 molecule * Measurable or evaluable metastatic disease * Must be HLA-A201 positive by standard HLA typing PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Greater than 3 months Hematopoietic: * Absolute neutrophil count greater than 1,000/mm\^3 * Platelet count greater than 100,000/mm\^3 * Hemoglobin greater than 8.0 g/dL Hepatic: * Bilirubin no greater than 2.0 mg/dL * ALT/AST less than 4 times upper limit of normal Renal: * Creatinine no greater than 1.6 mg/dL Cardiovascular: * For patients randomized to receive interleukin-2: * No major medical illnesses of the cardiovascular system Pulmonary: * For patients randomized to receive interleukin-2: * No major medical illnesses of the pulmonary system Other: * HIV negative * Hepatitis B antigen negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * For patients randomized to receive interleukin-2: * No active systemic infection * No other major medical illnesses of immune system * No coagulation disorders PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior biologic therapy Chemotherapy: * At least 4 weeks since prior chemotherapy Endocrine therapy: * No concurrent steroid therapy Radiotherapy: * At least 4 weeks since prior radiotherapy Surgery: * Not specified Other: * No concurrent active treatment of brain metastases
References
Publications (1)
- BACKGROUNDDudley ME, Wunderlich J, Nishimura MI, Yu D, Yang JC, Topalian SL, Schwartzentruber DJ, Hwu P, Marincola FM, Sherry R, Leitman SF, Rosenberg SA. Adoptive transfer of cloned melanoma-reactive T lymphocytes for the treatment of patients with metastatic melanoma. J Immunother. 2001 Jul-Aug;24(4):363-73. doi: 10.1097/00002371-200107000-00012. PMID 11565838