Phase 2
N=36
Vaccine Therapy in Treating HLA-A2 Positive Patients With Melanoma
Recurrent Melanoma · Stage IA Melanoma · Stage IB Melanoma · Stage IIA Melanoma · Stage IIB Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT00003895 ↗Enrolled (actual)
36
Serious AEs
2.8%
Results posted
Feb 2017
Primary outcome: Primary: T Cell Immunity to gp100 Peptide and to E7 12-20 Papilloma Virus Peptide — 0.02; 0.01; 0.97; 0.98 % of CD8+ T cells — p=<.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- HPV 16 E7:12-20 (Biological); gp100:209-217(210M) (Biological); laboratory biomarker analysis (Other)
- Age
- Pediatric, Adult, Older Adult · 17+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY T Cell Immunity to gp100 Peptide and to E7 12-20 Papilloma Virus Peptide |
0.02; 0.01; 0.97; 0.98; 0.61; 0.1 | <.001 sig |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00003895). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.