Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV Melanoma
Vaccination With Multiple Synthetic Melanoma Peptides Recognized by Helper T-Cells in Patients With Advanced Melanoma
NCT00089219CI-TRIAL-00016122completedPhase 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)
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: This randomized phase I/II trial is studying three different doses of a vaccine and comparing them to see how well they work in treating patients with stage IIIB, stage IIIC, or stage IV melanoma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intraocular Melanoma | Uveal Melanoma | ALIAS | 0.90 |
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 6MHP | Biological | — | UNRESOLVED |
| GM-CSF | Biological | — | UNRESOLVED |
| IFA | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm A. 6MHP vaccine 200 mcg
- description
- vaccine containing 6 melanoma helper peptides, at 200 mcg per peptide, with GM-CSF and IFA (Montanide ISA-51)
- interventionNames
- Biological: IFA
- Biological: 6MHP
- Biological: GM-CSF
- type
- EXPERIMENTAL
- label
- Arm B. 6MHP vaccine 400 mcg
- description
- vaccine containing 6 melanoma helper peptides, at 400 mcg per peptide, with GM-CSF and IFA (Montanide ISA-51)
- interventionNames
- Biological: IFA
- Biological: 6MHP
- Biological: GM-CSF
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of stage IIIB, IIIC, or IV melanoma * HLA-DR1, -DR4, -DR11, -DR13, or -DR15 positive * Brain metastases allowed at the discretion of the principle investigator PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count \> 1,000/mm\^3 * Platelet count \> 100,000/mm \^3 * Hemoglobin \> 9 g/dL Hepatic * Liver function tests ≤ 2.5 times upper limit of normal (ULN) Renal * Creatinine ≤ 1.5 times ULN Cardiovascular * No New York Heart Association class III or IV heart disease Other * Prior diagnosis of other cancer allowed * Not pregnant or nursing * Weight ≥ 110 pounds * No uncontrolled diabetes PRIOR CONCURRENT THERAPY: Biologic therapy * More than 4 weeks since prior growth factors * More than 4 weeks since prior allergy shots * More than 12 weeks since prior melanoma vaccine therapy\* NOTE: \*Prior melanoma vaccine allowed only for patients with disease progression during or after administration of the vaccine * No prior vaccination with any of the peptides used in this study Chemotherapy * More than 4 weeks since prior chemotherapy Endocrine therapy * More than 4 weeks since prior steroids Radiotherapy * More than 4 weeks since prior radiotherapy Surgery * Not specified Other * More than 1 month since prior investigational drugs or therapies * No other concurrent investigational drugs or therapies
References
Publications (3)
- RESULTSlingluff CL Jr, Petroni GR, Olson W, Czarkowski A, Grosh WW, Smolkin M, Chianese-Bullock KA, Neese PY, Deacon DH, Nail C, Merrill P, Fink R, Patterson JW, Rehm PK. Helper T-cell responses and clinical activity of a melanoma vaccine with multiple peptides from MAGE and melanocytic differentiation antigens. J Clin Oncol. 2008 Oct 20;26(30):4973-80. doi: 10.1200/JCO.2008.17.3161. Epub 2008 Sep 22. PMID 18809608
- DERIVEDShukla GS, Olson WC, Pero SC, Sun YJ, Carman CL, Slingluff CL Jr, Krag DN. Vaccine-draining lymph nodes of cancer patients for generating anti-cancer antibodies. J Transl Med. 2017 Aug 29;15(1):180. doi: 10.1186/s12967-017-1283-8. PMID 28851380
- DERIVEDDillon PM, Olson WC, Czarkowski A, Petroni GR, Smolkin M, Grosh WW, Chianese-Bullock KA, Deacon DH, Slingluff CL Jr. A melanoma helper peptide vaccine increases Th1 cytokine production by leukocytes in peripheral blood and immunized lymph nodes. J Immunother Cancer. 2014 Jul 15;2:23. doi: 10.1186/2051-1426-2-23. eCollection 2014. PMID 25126421