Vaccine Therapy in Treating Patients With Refractory Metastatic Melanoma
Immunization Of HLA-A*0201 or HLA-DPB1*04 Patients With Metastatic Melanoma Using Epitopes From The ESO-1 Antigen
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: Randomized phase II trial to study the effectiveness of vaccine therapy in treating patients who have refractory metastatic melanoma.
調査の概要
詳細な説明
OBJECTIVES:
- Determine whether an immunologic response can be obtained after administration of ESO-1 peptide vaccine comprising class I , II, or both peptides in HLA-A*201 or HLA-DPB1*04 positive patients with refractory metastatic melanoma expressing ESO-1.
- Determine the toxicity of this vaccine in these patients.
- Determine whether prior immunization with this vaccine results in increased clinical responsiveness in patients treated with interleukin-2.
OUTLINE: Patients are assigned to 1 of 3 groups according to HLA type.
- Group 1 (HLA-A*201 and HLA-DPB1*04 positive): Patients receive ESO-1 peptide vaccine comprising class I (ESO-1:157-165 [165V]) and class II (ESO-1:161-180) peptides subcutaneously once every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
- Group 2 (HLA-A*201 positive and HLA-DPB1*04 negative):Patients receive ESO-1 peptide vaccine as in group I comprising class I peptide only.
- Group 3 (HLA-A*201 negative and HLA-DPB1*04 positive):Patients receive ESO-1 peptide vaccine as in group I comprising class II peptide only.
Patients who develop disease progression discontinue vaccinations and receive high-dose interleukin (IL-2) IV over 15 minutes every 8 hours for up to 4 days (maximum of 12 doses). Treatment with IL-2 repeats every 10-14 days for 4 courses in the absence of disease progression (after at least 2 courses) or unacceptable toxicity.
Patients who have stable disease or a mixed or partial response to vaccination or IL-2 therapy may be eligible for additional vaccine therapy. Patients who have a complete response to vaccine therapy are eligible for 1 additional treatment.
Patients are followed at 3 weeks.
PROJECTED ACCRUAL: A total of 45-90 patients (15-30 per treatment group) will be accrued for this study within 1 year.
研究の種類
段階
- フェーズ2
連絡先と場所
研究場所
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Maryland
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Bethesda、Maryland、アメリカ、20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
DISEASE CHARACTERISTICS:
- Diagnosis of metastatic melanoma that expresses ESO-1 antigen
- Must have progressed during prior standard treatment
- Measurable or evaluable disease
- HLA-A*201 or HLA-DPB1*04 positive
PATIENT CHARACTERISTICS:
Age:
- 16 and over
Performance status:
- ECOG 0-2
Life expectancy:
- More than 3 months
Hematopoietic:
- WBC at least 3,000/mm^3
- Platelet count at least 90,000/mm^3
Hepatic:
- SGOT and SGPT less than 3 times normal
- Bilirubin no greater than 1.6 mg/dL (3.0 mg/dL for patients with Gilbert's syndrome)
- Hepatitis B surface antigen negative
Renal:
- Creatinine no greater than 2.0 mg/dL
Cardiovascular:
- No cardiac ischemia*
- No myocardial infarction*
- No cardiac arrhythmias* NOTE: *For interleukin-2 (IL-2) administration
Pulmonary:
- No obstructive or restrictive pulmonary disease (for IL-2 administration)
Immunologic:
- No autoimmune disease
- No active primary or secondary immunodeficiency
- HIV negative
- No active systemic infections
Other:
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other active major medical illness (for IL-2 administration)
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior ESO-1 immunization
Chemotherapy:
- Recovered from any prior chemotherapy
Endocrine therapy:
- No concurrent systemic steroid therapy
Radiotherapy:
- Recovered from any prior radiotherapy
Surgery:
- Not specified
Other:
- At least 3 weeks since any prior systemic therapy for cancer
- No other concurrent systemic therapy for cancer
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- マスキング：なし（オープンラベル）
協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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