Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Stage IV Melanoma
A Phase II Trial Of A D1/3-MAGE3-HIS Fusion Protein (NSC-719274) With Adjuvant SBAS02B (NSC-719275) For Patients With Stage IV, M1a or M1b Metastatic Melanoma
NCT00042783CI-TRIAL-00010955completedPhase 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. Vaccine therapy may be effective in treating stage IV melanoma. PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have stage IV 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| D1/3-MAGE-3-His fusion protein | Biological | — | UNRESOLVED |
| SB-AS02B adjuvant | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed stage IV melanoma that is considered incurable by surgery, radiotherapy, or limb perfusion * M1a or M1b disease * Measurable disease outside prior field of limb perfusion * Metastatic mucosal melanoma allowed * MAGE-3 positive by reverse transcription polymerase chain reaction * No uveal or choroidal primary melanoma * No prior or concurrent brain metastases by CT scan or MRI of the brain PATIENT CHARACTERISTICS: Age * Not specified Performance status * Zubrod 0-1 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Hepatitis B surface antigen negative * Hepatitis C negative * No liver cirrhosis * No unstable liver disease * No coagulation disorders Renal * Not specified Cardiovascular * No major cardiovascular illness * No myocardial infarction within the past 6 months Pulmonary * No major pulmonary illness Other * Not pregnant or nursing * Fertile patients must use effective contraception * HIV negative * No AIDS or HIV-1-associated complex * No chronic alcohol abuse or drug addiction * No systemic infections * No prior active autoimmune disease * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer from which the patient is currently disease-free PRIOR CONCURRENT THERAPY: Biologic therapy * At least 4 weeks since prior adjuvant biologic therapy * No prior biologic therapy for stage IV melanoma * No prior MAGE-3 peptide or protein vaccine preparation Chemotherapy * At least 4 weeks since prior adjuvant chemotherapy * No prior chemotherapy for stage IV melanoma Endocrine therapy * Not specified Radiotherapy * At least 4 weeks since prior adjuvant radiotherapy Surgery * At least 4 weeks since prior surgery Other * See Disease Characteristics * At least 3 weeks since prior limb perfusion and recovered * At least 4 weeks since other prior adjuvant therapy * No other prior therapy for stage IV melanoma
References
Publications (0)
Data not yet available
No reference posted for this study.