Clinical trial · Interventional
Vaccine Therapy in Treating Patients With Metastatic Melanoma
Phase I Protocol for the Evaluation of the Safety and Immunogenicity of Vaccination With a Synthetic Melanoma Peptide in Patients With High Risk Melanoma
- 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 peptide 946 may make the body build an immune response to kill tumor cells. Combining these vaccines with proteins from the tetanus vaccine, and/or with either QS21 or Montanide ISA-51 may be an effective treatment for metastatic melanoma. PURPOSE: Randomized phase I trial to study the effectiveness of vaccines made from peptide 946 with or without tetanus peptide, QS21, or Montanide ISA-51 in treating patients with metastatic melanoma that cannot be surgically removed or with melanoma that is likely to recur.
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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IFA (incomplete Freund's adjuvant) | Biological | — | UNRESOLVED |
| p946 | Biological | — | UNRESOLVED |
| p946/tet-p | Biological | — | UNRESOLVED |
| QS21 | Biological | — | UNRESOLVED |
| Tet-p | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Group 1: peptide 946 plus QS-21
- description
- 100 mcg peptide gp100 \[280-288\] plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
- interventionNames
- Biological: QS21
- Biological: p946
- type
- EXPERIMENTAL
- label
- Group 2. p946 plus IFA
- description
- 100 mcg peptide gp100 \[280-288\] plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
- interventionNames
- Biological: IFA (incomplete Freund's adjuvant)
- Biological: p946
- type
- EXPERIMENTAL
- label
- Group 3: p946 plus Tet-p plus QS-21
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion criteria: * Histologically confirmed unresectable metastatic melanoma (AJCC stage III or IV) OR resected melanoma with high risk of recurrence or mortality (stage IIB and above) * Age: 18 to 79 * Performance status: ECOG 0-2 * Life expectancy: Greater than 12 months * Hematopoietic: Absolute neutrophil count greater than 1,000/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 9 g/dL * Hepatic: AST and ALT no greater than 2.5 times upper limit of normal (ULN) Bilirubin no greater than 2.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN * Renal: Creatinine no greater than 1.5 times ULN Exclusion criteria: * patients currently receiving cytotoxic chemotherapy or who have received that therapy within the preceding 3 months * known or suspected allergies to any component of the treatment vaccine * unresectable tumor llikely to cause symptoms and for which therapy is anticipated within 3 months. * receiving acute treatment for seriouis infection within 14 days. * Patients with bulky disease, or with multiple brain metastases, but solitary brain metastases treated successfully with surgery or gamma knife may be eligible. * Any of the following with 3 months: * agentes with putative immunomodulating activity (except NSAIDs) * allergy desensitizing injections * other investigational agents * interferons * corticosteroids * any growth factors * prior melanoma vaccinations * pregnancy or the possibility of becoming pregnant on study * medical contraindication or potential problems in complying with the requirements of the protocol.
References
Publications (1)
- RESULTSlingluff CL Jr, Yamshchikov G, Neese P, Galavotti H, Eastham S, Engelhard VH, Kittlesen D, Deacon D, Hibbitts S, Grosh WW, Petroni G, Cohen R, Wiernasz C, Patterson JW, Conway BP, Ross WG. Phase I trial of a melanoma vaccine with gp100(280-288) peptide and tetanus helper peptide in adjuvant: immunologic and clinical outcomes. Clin Cancer Res. 2001 Oct;7(10):3012-24. PMID 11595689