Clinical trial · Interventional
Vaccine Therapy in Treating Patients With High-Risk Stage III or Completely Resected Metastatic Melanoma
Phase II Randomized Study of CD34+ Derived or Peripheral Monocyte Derived Dendritic Cells Pulsed With MART-1 and gp100 Melanoma Antigens in Patients With High Risk Stage III or Completely Resected Metastatic Melanoma
NCT00019890CI-TRIAL-00074620completedPhase 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 to kill tumor cells. PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy in treating patients who have high-risk stage III or completely resected metastatic melanoma.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dendritic cell-gp100-MART-1 antigen vaccine | Drug | — | UNRESOLVED |
| sargramostim | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- High risk stage III melanoma (greater than 3 lymph nodes positive) OR completely resected metastatic melanoma within 6 months of surgery Disease free by CT scan HLA-A201 positive --Prior/Concurrent Therapy-- Biologic therapy: At least 4 weeks since prior biologic therapy No prior MART-1 or gp100 peptide immunization No concurrent biologic therapy Chemotherapy: At least 4 weeks since prior chemotherapy No concurrent chemotherapy Endocrine therapy: At least 4 weeks since prior endocrine therapy No concurrent systemic steroid therapy Radiotherapy: At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics No concurrent surgery --Patient Characteristics-- Age: 16 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 90,000/mm3 No coagulation disorder Hepatic: Bilirubin no greater than 1.6 mg/dL AST or ALT less than 3 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No major cardiac disease Pulmonary: No major pulmonary disease Other: Not pregnant or nursing Fertile patients must use effective contraception No active systemic infection No autoimmune disorders HIV negative Hepatitis B surface antigen negative
References
Publications (0)
Data not yet available
No reference posted for this study.