Clinical trial · Interventional
Trial of Autologous, Hapten-Modified Vaccine in Patients With Stage III or IV Melanoma
M-Vax: A Feasibility and Bio-Equivalence Study Using a DNP-Modified Autologous Melanoma Tumor Cell Vaccine as Therapy in Patients With Stage III or IV Melanoma
NCT00257465CI-TRIAL-00020056completedPhase 1 / Phase 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)
The purpose of this study is to determine whether a vaccine composed of patients' own melanoma cells treated with the chemical, dinitrophenyl (DNP)(called a hapten), is safe and stimulates an immune response to patients' own cancer cells.
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 | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous, DNP-Modified Melanoma Vaccine | Biological | — | UNRESOLVED |
| Autologous, DNP-Modified Vaccine | Biological | — | UNRESOLVED |
| Autologous, DNP-modified vaccine (M-Vax) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- A
- description
- 'Autologous, DNP-modified vaccine (M-Vax)'
- interventionNames
- Biological: Autologous, DNP-modified vaccine (M-Vax)
- Biological: Autologous, DNP-Modified Melanoma Vaccine
- type
- EXPERIMENTAL
- label
- B
- description
- Autologous, DNP-Modified Vaccine (MVax)
- interventionNames
- Biological: Autologous, DNP-modified vaccine (M-Vax)
- Biological: Autologous, DNP-Modified Vaccine
- type
- EXPERIMENTAL
- label
- C
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * stage III or IV melanoma at least one tumor mass of at least 2.5 cm diameter that can be excised to make vaccine good performance status Exclusion Criteria: * brain metastases need for steroids or other immunosuppressive drugs positive PPD tests positive test for HIV, hepatitis B (antigen), or hepatitis C other serious medical illnesses
References
Publications (1)
- BACKGROUNDBerd D, Sato T, Maguire HC Jr, Kairys J, Mastrangelo MJ. Immunopharmacologic analysis of an autologous, hapten-modified human melanoma vaccine. J Clin Oncol. 2004 Feb 1;22(3):403-15. doi: 10.1200/JCO.2004.06.043. Epub 2003 Dec 22. PMID 14691123