Clinical trial · Interventional
Booster Vaccination in Preventing Disease Recurrence in Previously Vaccinated Patients With Melanoma That Has Been Removed By Surgery
A Pilot Study to Assess the Immunologic Response to Booster Vaccination With a Modified gp100 Melanoma Peptide (209-2M) Vaccine in Previously Vaccinated HLA-A2.1+ Patients With Melanoma
NCT01989559CI-TRIAL-00016694completedPhase 1ClinicalTrials.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)
This pilot clinical trial studies booster vaccination in preventing disease recurrence in previously vaccinated patients with melanoma that has been removed by surgery. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving booster vaccinations may make a stronger immune response and prevent or delay the recurrence of cancer.
Conditions
Conditions (10)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Melanoma | Melanoma | CURATED_BROADER | 0.78 |
| Stage IA Skin Melanoma | Cutaneous Melanoma | CURATED_BROADER | 0.78 |
| Stage IB Skin Melanoma | Cutaneous Melanoma | CURATED_BROADER | 0.78 |
| Stage IIA Skin Melanoma | Cutaneous Melanoma | CURATED_BROADER | 0.78 |
| Stage IIB Skin Melanoma | Cutaneous Melanoma | CURATED_BROADER | 0.78 |
| Stage IIC Skin Melanoma | Cutaneous Melanoma | CURATED_BROADER | 0.78 |
| Stage IIIA Skin Melanoma | Cutaneous Melanoma | CURATED_BROADER | 0.78 |
| Stage IIIB Skin Melanoma | Cutaneous Melanoma | CURATED_BROADER | 0.78 |
| Stage IIIC Skin Melanoma | Cutaneous Melanoma | CURATED_BROADER |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gp100:209-217(210M) Peptide Vaccine | Biological | — | UNRESOLVED |
| HPV 16 E7:12-20 Peptide Vaccine | Biological | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (vaccine therapy)
- description
- Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine with Montanide ISA 51 VG or Montanide ISA 51 SC on day 1 and between days 25-30. After 6 months, patients free of disease receive booster injections every 6 months for 3 years in the absence of unacceptable toxicity or disease progression.
- interventionNames
- Biological: gp100:209-217(210M) Peptide Vaccine
- Biological: HPV 16 E7:12-20 Peptide Vaccine
- Other: Laboratory Biomarker Analysis
Primary outcomes (2)
- measure
- Percentage of positive CD8+ T cells
- timeFrame
- Up to 11 years
- description
- Characterized using three different in vitro assays. Fresh and cryopreserved peripheral blood mononuclear cells (PBMC) will be analyzed for gp100 peptide-specific CD8+ T cells using a fluorescinated, modified gp100, peptide-specific, A2-restricted tetramer binding assay and the interferon (IFN) gamma specific enzyme-linked immunosorbent spot (ELISPOT) and cytokine flow cytometry (CFC) assays.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Patients must have completed treatment on protocol 99-9 \[T98-0081\] "A Randomized Phase II Trial to Determine the Immune Response to a Mutated gp100 Melanoma Peptide Vaccine in HLA-A2.1+ Patients with a \> 1mm Melanoma on Initial Biopsy;" patients are not required to have received every planned vaccine as long as the reason for stopping was not disease progression or dose limiting toxicity * Patients must be \>= 12 months from their last vaccination with gp100 and be free of melanoma; patients who have remained continuously free of disease and patients who have had a recurrence that has been completely resected (stage IV no evidence of disease \[NED\]) are eligible * Patients must have a good performance status (Karnofsky performance status \[PS\] 80-100) * White blood cells (WBC) \>= 3500/mm\^3 * Platelets (plt) \>= 100,000/mm\^3 * Hemoglobin \>= 9 gm/100 ml * Serum creatinine =\< 2 mg/dl * Total bilirubin =\< 2.0 mg/dl * Patients must have recovered from any effects of major surgery and be free of significant systemic infection * Women of childbearing potential must have a negative pregnancy test and must avoid becoming pregnant while on treatment; men must avoid fathering a child while on treatment * Patients must give written informed consent prior to initiation of therapy * Patients with a history of psychiatric illness must be judged able to fully understand the investigational nature of the study and the risks associated with the therapy Exclusion Criteria: * Patients must not have clinically detectable melanoma * Patients who require or are likely to require systemic corticosteroids for intercurrent illness are ineligible * Patients with any significant medical disease other than the melanoma, which in the opinion of the investigator would significantly increase the risk of immunotherapy, are ineligible * Patients should be free of any other cancers or deemed at low risk for their recurrence
References
Publications (0)
Data not yet available
No reference posted for this study.