Vaccine Therapy in Treating HLA-A2 Positive Patients With Melanoma (NCT00003895) | Clinical Trial Compass
CompletedPhase 2
Vaccine Therapy in Treating HLA-A2 Positive Patients With Melanoma
United States36 participantsStarted 1999-04
Plain-language 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.
Who can participate
Age range17 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 mu…
What they're measuring
1
T Cell Immunity to gp100 Peptide and to E7 12-20 Papilloma Virus Peptide