Clinical trial · Interventional
Vaccine Therapy in Treating HLA-A2 Positive Patients With Melanoma
A Randomized Phase II Trial to Determine the Immune Response to a Mutated gp100 Melanoma Peptide (209-2M) Vaccine in HLA-A2 Positive Patients With a >1mm Melanoma on Initial Biopsy
NCT00003895CI-TRIAL-00026051completedPhase 2Results postedClinicalTrials.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 randomized pilot phase II trial studies how well vaccine therapy works in treating human leukocyte antigen class 1 histocompatibility, A-2 (HLA-A2) positive patients with melanoma. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells.
Conditions
Conditions (9)
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 Melanoma | Melanoma | CURATED_BROADER | 0.78 |
| Stage IB Melanoma | Melanoma | CURATED_BROADER | 0.78 |
| Stage IIA Melanoma | Melanoma | CURATED_BROADER | 0.78 |
| Stage IIB Melanoma | Melanoma | CURATED_BROADER | 0.78 |
| Stage IIC Melanoma | Melanoma | CURATED_BROADER | 0.78 |
| Stage IIIA Melanoma | Melanoma | CURATED_BROADER | 0.78 |
| Stage IIIB Melanoma | Melanoma | CURATED_BROADER | 0.78 |
| Stage IIIC Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gp100:209-217(210M) | Biological | — | UNRESOLVED |
| HPV 16 E7:12-20 | Biological | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- gp100:209-217(210M) + HPV 16 E7:12-20 (every 2 weeks)
- description
- Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine mixed with incomplete Freund's adjuvant SC every 2 weeks for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo laboratory biomarker analysis.
- interventionNames
- Biological: HPV 16 E7:12-20
- Biological: gp100:209-217(210M)
- Other: laboratory biomarker analysis
- type
- EXPERIMENTAL
- label
- gp100:209-217(210M) + HPV 16 E7:12-20 (every 3 weeks)
- description
- Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine mixed with incomplete Freund's adjuvant SC every 3 weeks for 6 months. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients undergo laboratory biomarker analysis.
- interventionNames
- Biological: HPV 16 E7:12-20
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 17 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have histologically confirmed primary melanoma of Breslow thickness 1.0-4.0 mm; patients who have had only their initial biopsy are preferred; however, those who have already undergone a wide local excision are also eligible; patients may be enrolled up to three months after their wide local excision * Patients whose melanoma is \> 4.0 mm thick who have positive or negative regional lymph nodes are also eligible * After accrual to the original 26 patient goal, all patients must be enrolled prior to sentinel lymph node dissection; patients with previous lymph node dissection will not be eligible * Patients must be HLA typed and be shown to be HLA-A2.1+ by either serologic techniques, flow cytometry, or molecular techniques * Patients must be ambulatory with good performance status (Karnofsky performance status \[PS\] 80-100) * White blood cell (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 * Patients must be negative for human immunodeficiency virus (HIV) antibody by enzyme-linked immunosorbent assay (ELISA) (or negative by Western blot if ELISA is positive) if they are considered to be at high risk; others do not require serologic testing if there are no symptoms or risk factors for HIV disease * Women of childbearing potential must have a negative pregnancy test and should avoid becoming pregnant while on treatment * Patients must give written informed consent prior to initiation of therapy; patients with a history of major 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 distant metastases * Patients who require or are likely to require systemic corticosteroids for intercurrent illness * Patients with any significant medical disease other than the malignancy (e.g. chronic obstructive pulmonary disorder \[COPD\], patients with ascites or pleural effusions) which in the opinion of the investigator would significantly increase the risk of immunotherapy * Patient 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.