Vaccination With Synthetic Melanoma Peptides Administered With GM-CSF-in-Adjuvant in Patients With Advanced Melanoma
Data Collection
Melanoma+8
+ Neoplasms
+ Neoplasms by Histologic Type
Treatment Study
Summary
Study start date: August 1, 2002
Actual date on which the first participant was enrolled.OBJECTIVES: * Determine the antitumor immune response in patients with unresectable stage III or IV melanoma treated with vaccine comprising multiple synthetic melanoma peptides, sargramostim (GM-CSF), and Montanide ISA-51. OUTLINE: Patients receive vaccine comprising multiple synthetic melanoma peptides, sargramostim (GM-CSF), and Montanide ISA-51 on days 1, 8, 15, 29, 36, and 43. Patients undergo removal of the lymph node draining the vaccination site on day 22 to assess immune response. PROJECTED ACCRUAL: A maximum of 29 patients will be accrued for this study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.7 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 12 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: * Diagnosis of melanoma * Unresectable stage III or IV disease * Mucosal or ocular disease allowed * Positive HLA-A1, -A2, or -A3 expression PATIENT CHARACTERISTICS: Age * 12 and over Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count \> 1,000/mm\^3 * Platelet count \> 100,000/mm\^3 * Hemoglobin \> 9 g/dL Hepatic * Liver function tests ≤ 2.5 times upper limit of normal (ULN) Renal * Creatinine ≤ 1.5 times ULN Cardiovascular * No New York Heart Association class III or IV heart disease Other * Weight ≥ 100 pounds * Not pregnant or nursing * No other malignancy within the past 5 years except squamous cell or basal cell skin cancer without known metastasis, carcinoma in situ of the breast, or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy * No prior vaccination with any of the peptides used in this protocol * More than 1 year since prior melanoma vaccine therapy * More than 4 weeks since prior immunotherapy * More than 4 weeks since prior growth factors * More than 4 weeks since prior allergy shots Chemotherapy * More than 4 weeks since prior chemotherapy Endocrine therapy * More than 4 weeks since prior steroid therapy Radiotherapy * More than 4 weeks since prior radiotherapy Surgery * Prior tumor resection allowed
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location